NDC | 0363-9116-06 |
Set ID | 204b96bc-af4e-4842-8b57-7b416feb4dd9 |
Category | HUMAN OTC DRUG LABEL |
Packager | Walgreen Company |
Generic Name | |
Product Class | Amide Local Anesthetic, Antiarrhythmic |
Product Number | |
Application Number | PART348 |
- Active Ingredients
- Purpose
- Dosage and Administration
- Warnings
- Idications and Usage
-
When using this product
■ use only as directed
■ read and follow all directions and warnings on this carton
■ do not allow contact with the eyes
■ do not use at the same time as other topical analgesics
■ do not bandage tightly or apply local heat (such as heating pads) to the area of use
■ do not microwave
■ 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 consult a doctor
- PREGNANCY OR BREAST FEEDING
- Do not Use
- Keep out of reach of children and pets.
- Other Safety Information
- Inactive Ingredients
- Questions
- PRINCIPAL DISPLAY PANEL
-
INGREDIENTS AND APPEARANCE
PAIN RELIEF PATCHES
lidocaine kitProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:0363-9116 Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0363-9116-06 1 in 1 KIT 04/01/2019 Quantity of Parts Part # Package Quantity Total Product Quantity Part 1 2 PATCH 18 g Part 2 2 PATCH 18 g Part 3 2 PATCH 18 g Part 1 of 3 SMALL PAIN RELIEF PATCHES
lidocaine patchProduct Information Item Code (Source) NDC:0363-9117 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987) LIDOCAINE 9 g in 100 g Inactive Ingredients Ingredient Name Strength Aluminum (UNII: CPD4NFA903) Glycerin (UNII: PDC6A3C0OX) Kaolin (UNII: 24H4NWX5CO) Methylparaben (UNII: A2I8C7HI9T) POLYACRYLIC ACID (300000 MW) (UNII: A8371R0U5J) POLYSORBATE 80 (UNII: 6OZP39ZG8H) Propylene Glycol (UNII: 6DC9Q167V3) Propylparaben (UNII: Z8IX2SC1OH) COPOVIDONE K25-31 (UNII: D9C330MD8B) SODIUM POLYACRYLATE (2500000 MW) (UNII: 05I15JNI2J) TARTARIC ACID (UNII: W4888I119H) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) WATER (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 1 in 1 POUCH 1 9 g in 1 PATCH; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part348 Part 2 of 3 MEDIUM PAIN RELIEF PATCHES
lidocaine patchProduct Information Item Code (Source) NDC:0363-9118 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987) LIDOCAINE 9 g in 100 g Inactive Ingredients Ingredient Name Strength Aluminum (UNII: CPD4NFA903) Glycerin (UNII: PDC6A3C0OX) Kaolin (UNII: 24H4NWX5CO) Methylparaben (UNII: A2I8C7HI9T) POLYACRYLIC ACID (300000 MW) (UNII: A8371R0U5J) POLYSORBATE 80 (UNII: 6OZP39ZG8H) Propylene Glycol (UNII: 6DC9Q167V3) Propylparaben (UNII: Z8IX2SC1OH) COPOVIDONE K25-31 (UNII: D9C330MD8B) SODIUM POLYACRYLATE (2500000 MW) (UNII: 05I15JNI2J) TARTARIC ACID (UNII: W4888I119H) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) WATER (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 1 in 1 POUCH 1 9 g in 1 PATCH; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part348 Part 3 of 3 LARGE PAIN RELIEF PATCHES
lidocaine patchProduct Information Item Code (Source) NDC:0363-9119 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987) LIDOCAINE 9 g in 100 g Inactive Ingredients Ingredient Name Strength Aluminum (UNII: CPD4NFA903) Glycerin (UNII: PDC6A3C0OX) Kaolin (UNII: 24H4NWX5CO) Methylparaben (UNII: A2I8C7HI9T) POLYACRYLIC ACID (300000 MW) (UNII: A8371R0U5J) POLYSORBATE 80 (UNII: 6OZP39ZG8H) Propylene Glycol (UNII: 6DC9Q167V3) Propylparaben (UNII: Z8IX2SC1OH) COPOVIDONE K25-31 (UNII: D9C330MD8B) SODIUM POLYACRYLATE (2500000 MW) (UNII: 05I15JNI2J) TARTARIC ACID (UNII: W4888I119H) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) WATER (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 1 in 1 POUCH 1 9 g in 1 PATCH; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part348 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part348 04/01/2019 Labeler - Walgreen Company (008965063) Establishment Name Address ID/FEI Business Operations Foshan Aqua Gel Biotech Co.,Ltd. 529128763 manufacture(0363-9116)