This disclosure relates to pharmacy and medicinal labels.
Labels units can be used to convey brand identity as well as relevant information such as portion or dose size, recommended use frequency, expiration date, contraindications and the like. In certain products, including but not limited to prescription and non-prescription, an extensive amount of information must be made available to the end consumer. The vast amount of information cannot be easily placed on a conventional two-dimensional label. In certain situations this information is presented on package inserts that are placed lose in boxes or other packaging associated with the container or other delivery device such as an inhaler injection unit or the like. This information can easily become separated from the container or delivery device and be unavailable to the end user when needed.
Materials such as prescription and over-the-counter pharmaceuticals are typically produced by pharmaceutical manufacturers and packagers distributed through a multilayer distribution chain before reaching the end use consumer. In many situations, the pharmaceutical manufacturer and/or packager is charged with the responsibility to see that the appropriate information regarding the compound to be administered reaches the end use consumer. In certain situations, it has been found that package inserts present in an associated box or outer package is not fully effective to this end.
Label configurations have been proposed that can integrate some or all of the desired dosing instruction, contraindications, potential side effects, efficacy, etc., much of which can be required by relevant state and federal regulatory agencies, to the end-use consumer. In many situations, the associated label can be affixed to the container or other dispenser in an essentially permanent manner and can include a folded insert that includes the required information in a pocket defined therein. In certain instances, depending on the associated material being conveyed, the insert can be a multi-folded unit that having multiple faces that bear written indicia associated with information important to the user. In the situations associated with pharmaceutical compositions, the label and associated insert will be sized to fit the associated container. It is desirable that this insert be positioned in the associated label in a manner to permit the user to access and/or remove the insert when desired or required. It is important that the associated label be tamper-resistant and that any attempted tampering be readily apparent. Thus it is desirable to provide a label that can provide indication of tampering and can maintain a folded label member in secure relationship thereto.
Disclosed herein are implementations of a label having a base label member, a fold label member that is in overlying relationship to the base label member. The base label member has a first base label face and a second base label face opposed to the first face. When the fold label member is in the folded state, the folded label member has a first outwardly oriented fold label member face and a second outwardly oriented fold label member face opposed to the first outwardly oriented fold label member face. The label also includes a lamination layer in overlying relationship with the base label member and the fold label member. The lamination layer has a first lamination layer face and a second lamination layer face opposed to the first lamination layer face. The label has a glue hinge that is interposed between the base label member and the lamination layer. In certain embodiments, the glue hinge is positioned in overlaying relationship to a region that is defined on the first base label face and in contact with the fold label member and the lamination layer.
The disclosure is best understood from the following detailed description when read in conjunction with the accompanying drawings. It is emphasized that, according to common practice, the various features of the drawings are not to-scale. On the contrary, the dimensions of the various features are arbitrarily expanded or reduced for clarity.
Disclosed is a label that can be employed to identify products such as medicinal products such as prescription pharmaceuticals, over-the-counter pharmaceuticals as well as other products and/or compounds that require dosing or use instructions. The label as broadly described includes a base label member, a fold label member, and a lamination layer that overlies the base label member and the fold label member. A glue hinge is interposed between the base label member and the fold label member in a manner that contacts both the base label member and the fold label member and is also in contact with the lamination layer. In certain embodiments, the label can also include a support substrate such as a liner layer or the like.
An embodiment of the label 10 is depicted in the various drawing figures. Turning first to
In the embodiment depicted in the various drawing figures, the label 10 and its various component elements are depicted as rectilinear planar members. It is within the purview of this disclosure that the one of more of the elements can have other suitable configuration(s) based upon considerations that include but are not limited to the desired location on the container in question.
The base label member 12 can be of any size and shape suitable to be affixed to the associated container. In certain embodiments, the base label member 12 can have a square or rectilinear configuration however other configurations are considered to be with in the purview of this disclosure. The base label member 12 can have an area AB between 0.2 square inches and 30 square inches in certain embodiments. The base member 12 can have a suitable thickness sufficient to provide structural support the associated label 10.
In certain embodiments, the base label member can be rectilinear and have dimensions up to 5 inches by up to 8 inches, with dimensions between 0.5 and 2 inches by between 0.5 and 4 inches in certain applications. In certain applications, the base label 12 can have dimensions between 0.5 and 1 inch×between 0.5 and 2 inches.
At least one of the first base label face 14 or the second base label face 16 can be configured with indicia 50 that can include artwork, writing or the like. The indicia 50 can be imparted on the first base label face 14 and/or the second base label face 16 by any suitable method such as printing embossing and the like. In certain embodiments, it is contemplated that the indicia 50 will be imparted on the base label face 14, 16 that will be outwardly oriented when the label 10 is in position on the associated substrate such as the desired container. In the various drawing figures base label face 14 is depicted being outwardly oriented in various drawing figures.
In the embodiments depicted in the various drawing figures, the base label member 12 has a rectilinear configuration with a base member length (LB) and a base label member width (WB). In certain embodiments, the base member length (LB) can have a value between 0.2 and 8 inches while the base label member width (WB) can be between about 0.2 and 6 inches. In certain embodiments, the base label member can have a length (LB) between 0.5 and 4 inches and a width (WB) between 0.5 and 3 inches.
The base label member 12 can also include suitable means for attaching the base label member 12 to a suitable substrate such as substrate S as depicted in
The label 10 also includes a fold label member 18 that is located in overlying relationship to the base label member 12. The fold label member 18 can include at least one leaf or page. In many applications, the fold label member 18 can include a plurality of leaves or pages that are connected to one another. The plurality of leaves or pages can be connected to one another by binding as a codex, by folding, by pleating or the like such that, when the fold label member 18 is in the folded state, it includes a first outwardly oriented fold label member face 20 and a second outwardly oriented fold label member face 22 that is opposed to the first outwardly oriented fold label member face 20. The various pages or leaves can include printed material related to dosing instructions, use instructions, adverse indications, etc. as required. In certain embodiments, it is contemplated that at least one of the first outwardly oriented fold label member face 20 or the second outwardly oriented fold label member face 22 can include indicia 52 so located that the indicia 52 can be identified when he associated label 10 is in the use position. The fold label member 18 can be composed of any suitable material. In certain embodiments, the fold label member 18 can be composed of a suitable paper.
The fold label member 18 can have dimensions in either length, width or both, that are equal to or are less than corresponding dimensions of the associated base label member 12 as illustrates can be seen in the embodiment depicted in
In the various embodiments, the fold label member 18 can be contact with at least a portion of the first base label face 14 of the base label member 12. In certain embodiments, the two respective members are oriented in parallel planar alignment with one another. In the embodiment as illustrated, the fold label member 18 is in direct contact with the base label member 12.
The label 10 also includes a lamination layer 24 that is in overlying relationship with the base label member 12 and the fold label member 18 such that the fold label member 18 is interposed between the base label member 12 and the lamination layer 24. In certain embodiments, the lamination layer 24 is an elongate body that has a first lamination layer face 26 and an opposed second lamination layer face 28. The lamination layer 12 can be composed of any suitable material such as a polymeric film or the like. In certain embodiments, it is contemplated that the polymer film material can be a transparent material that will permit visibility of any layers and/or indicia that underlie the lamination layer, for example indicia 54 present on the first outwardly oriented face 20 of the fold label member 18. This can facilitate user identification of the label 10 and the presence and nature of the fold label member 18.
The lamination layer 24 can include means for affixing the lamination layer 24 to the base label member 12 with the fold label member 18 interposed in between. The affixing means can be a suitable adhesive layer positioned on the second lamination layer face 28 at suitable locations. The adhesive employed in the adhesive layer can be one suitable for attaching the lamination layer 24 to the base layer member 12. The adhesive employed can be one that provides a sufficient prying force to permit disengagement of the lamination layer 24 from the base member layer 12 when access to the fold label member 18 is desired.
As illustrated in
The label 10 also includes a glue hinge 30 that is positioned in overlaying relationship with a region defined on the first base label face 14 of the base label member 12. The glue hinge 30 is in contact with the first base label face 14 at a location and in a manner that facilitates contact with and connection to both the lamination layer 24 and the fold label member 18 when the components of the label 10 are in their assembled state.
In the embodiment as depicted in the various drawing figures, the glue hinge 30 can be a suitably configured member that has a glue hinge area (AG) that is less than the value of base label member area (AB). In certain embodiments, the glue hinge 30 can be an elongated rectilinear member that has a length LG that is less than the length LB of base label member 12. The length LG of glue hinge 30 will be sufficient to permit visibility of indicia 50 when fold label member 18 is not in overlying relationship thereto.
The glue hinge 30 can be positioned in offset relationship relative to a central region defined in the base label member 12. Where desired or required, the glue hinge 30 can be located on the base label member 12 at a position proximate to the base label member leading edge 38 of base label member 12 in spaced relationship there from to define an offset length O1. In certain embodiments, the offset length O1 can have a value that is between 5% and 20% of the length LB of the base label member 12. Where desired or required, the glue hinge 30 can have a leading edge and an opposed trailing edge.
In certain embodiments, the glue hinge 30 can have a width WG that is between 60% and 95% of the width WB of the base label member 12. In embodiments in which the glue hinge is an elongate rectilinear member, it is contemplated that the width WG will be sufficient to permit the glue hinge 30 to affix to the base label member 12. In certain embodiments, the length LG of the glue hinge 30 can have a value that is between 10% and 40% greater than the length LB of base label member 12. The glue hinge 30 can have an offset value O3 as measured from the leading edge 38 of the base label member 12 to the trailing edge of the glue hinge 30 that is between 40 and 80% of the value of O1.
The glue hinge 30 can be composed of a suitable adhesive material or materials sufficient to affix the fold label member 18 to the base label member 12 in a manner that facilitates access to the multiple pages or leaves present in the fold label member 18. In certain embodiments, the glue hinge 30 can include one or more suitable hot melt adhesive(s). Non-limiting examples of suitable hot melt adhesives include one or more of the following: various ethylene vinyl acetate copolymeric resin compositions, ethylene acetate copolymeric resins, polyolefins, polyamides and the like. The hot melt adhesive may also include one or more of the following additive: tackifying resins, waxes, plasticizers and the like.
The fold label member 18 can be configured as an elongated member with a fold label member attachment edge 42 and a fold label member trailing edge 44 that is opposed to the fold member attachment edge 42. In an embodiment of the label 10 as disclosed herein, the attachment edge 42 and a region proximate thereto are adhesively connected to an outwardly oriented face of the glue hinge 30 such that the fold label member 18 overlays a portion of the outwardly oriented face of the glue hinge 30 and a portion of the adhesive material that makes up the glue hinge 30 remains exposed when the fold label member 18 is in position and is in direct contact with the associated region of second lamination layer face 28.
In certain embodiments, the fold label member attachment edge 42 is positioned at a region central to the elongate body of the glue hinge 30 and defines an offset value O2 as measured from the leading edge 38 of the base label member 12 to the attachment edge 42 of the fold label member 18 in which the value of O2 is less that O3 and greater than O1. The generally elongate region of the glue hinge 30 that is exposed when the fold label member 18 is affixed to the glue hinge 30 will have a value O4. In the embodiment depicted in
In certain embodiments, the width WF of the fold label member 18 can have a value that is equal to or less than the width WG of glue hinge 18. In certain embodiments, the ratio of the width WF of fold layer member 18 to the width WG of glue hinge 18 can be between 0.5:1 and 1:1. In various embodiments, the fold layer member 18 can be centered relative to the glue hinge 18. In embodiments where the width WF of fold layer member 18 is less than the width WG of glue hinge 18, it is contemplated that the resulting assembly of glue hinge 18 and fold label member 18 will include side tab regions 31 defined on the glue hinge 18.
Where desired or required, the glue hinge 18 can be configured with suitable tamper indicators that would indicate that the label has been altered from its as manufactured state. Such alterations can include removal and/or replacement of the fold label member 18, etc. Non-limiting examples of tamper indicators can include stress indicators integrated in the glue hinge that are triggered by movement/removal of the overlying lamination layer 24.
The lamination layer 24 that overlays the base layer member 12 and fold label member 18 can have dimensions equal to the dimensions of the base label member 12 if desired or required. When the lamination layer 24 is in position overlaying the glue hinge 30 and the fold label member 18, one or more outer edges of the lamination layer 24 can extend beyond one or more outer edges defined in the fold label member 12 and the glue hinge 18 when the various members are assembled together as can be seen in
The trailing edges of the respective members of the label 10 can be configures such that the fold label member 18 is encased between the lamination layer 24. One non-limiting example of such encasement is the embodiment depicted in
The label 10 is configured to be attached to a suitable support surface. As discussed previously in the use position, the label 10 can be affixed to a suitable container device such as that depicted in
It is also within the purview of this disclosure that label 10 include a suitable support surface such a liner layer 34 which may be employed as a transfer or storage aid prior to affixing the label 10 to the container substrate S. The liner layer 34 can have a support face 36 that is in releasable contact with the second base label face 16 of the base label member 12. The liner layer 34 can be an elongate body configured to carry one or more labels 10 thereon and to facilitate transfer of individual labels 10 to respective containers S. In the embodiment illustrated in
While the disclosure has been described in connection with certain embodiments, it is to be understood that the disclosure is not to be limited to the disclosed embodiments but, on the contrary, is intended to cover various modifications and equivalent arrangements included within the scope of the appended claims, which scope is to be accorded the broadest interpretation so as to encompass all such modifications and equivalent structures as is permitted under the law.
This application claims priority to and the benefit of U.S. Provisional Application Patent Ser. No. 62/440,611, filed Dec. 30, 2016, the entire disclosure of which is hereby incorporated by reference.
Number | Date | Country | |
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62440611 | Dec 2016 | US |