NDC | 67510-0280-1 |
Set ID | 66b4fa17-7b2f-b12d-e053-2991aa0a52fc |
Category | HUMAN OTC DRUG LABEL |
Packager | Kareway Product, Inc. |
Generic Name | |
Product Class | Amide Local Anesthetic, Antiarrhythmic |
Product Number | |
Application Number | PART348 |
- Active ingredient
- Purposes
- Uses
- Warnings
- Do Not Use
-
When Using This Product
- use only as directed. Read and follow all directions and warnings on this label.
- rare cases of serious burns have been reported with products of this type
- do not apply to wounds or damaged, broken or irritated skin
- do not allow contact with the eyes and mucous membranes
- do not bandage tightly or apply local heat (such as heating pads) to the area of use
- do not use at the same time as other topical analgesics
- dispose of used patch in manner that always keeps product away from children and pets. Used patches still contain the drug product that can produce serious adverse effects if a child or pet chews or ingests this patch.
- Stop Use and Ask a Doctor if
- If Pregnant or Breast-Feeding
- Keep Out of Reach of Children and Pets
-
Directions
adults and children over 12 years:
- clean and dry affected area
- remove backing from patch by firmly grasping both ends and gently pulling until backing separates in middle
- carefully remove smaller portion of backing from patch and apply exposed portion of patch to affected area
- once exposed portion of patch is positioned, carefully remove remaining backing to completely apply patch to affected area
- use 2 patch for up to 24 hours
children 12 years or younger: ask a doctor
- Inactive Ingredients
- Package/Label Principal Display Panel
-
INGREDIENTS AND APPEARANCE
PURE-AID
lidocaine, menthol patchProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:67510-0280 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987) LIDOCAINE 240 mg Inactive Ingredients Ingredient Name Strength POLYSORBATE 80 (UNII: 6OZP39ZG8H) DIHYDROXYALUMINUM AMINOACETATE (UNII: DO250MG0W6) GLYCERIN (UNII: PDC6A3C0OX) METHYLPARABEN (UNII: A2I8C7HI9T) KAOLIN (UNII: 24H4NWX5CO) PROPYLPARABEN (UNII: Z8IX2SC1OH) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) TARTARIC ACID (UNII: W4888I119H) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) WATER (UNII: 059QF0KO0R) POLYACRYLIC ACID (8000 MW) (UNII: 73861X4K5F) SODIUM POLYACRYLATE (8000 MW) (UNII: 285CYO341L) POVIDONE (UNII: FZ989GH94E) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:67510-0280-1 1 in 1 POUCH; Type 0: Not a Combination Product 03/02/2018 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part348 03/02/2018 Labeler - Kareway Product, Inc. (121840057)