Label: LIDOCAINE PAIN RELIEVING GEL-PATCH- lidocaine 4% patch
- NDC Code(s): 81533-201-05
- Packager: Noble OTC LLC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated March 1, 2024
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Active Ingredient
- Purpose
- INDICATIONS & USAGE
- Warnings
- Stop use and ask a doctor
- Keep out of the reach of children
- Do Not Use
- If Pregnant or Breast-Feeding
- When Using this product
-
Directions
Adult and children 12 years of age and over:
- Clean and dry affected area
- Remove film from patch and apply to the skin
- Apply 1 patch at a time to affected area, not more than 3 to 4 times daily
- Remove patch from teh skin after at most 8-hour application
- Children under 12 years of age. Consult a doctor
- Other information
- Inactive Ingredients
- Questions or Comments
- Distributed By
- PRINCIPAL DISPLAY PANEL
-
INGREDIENTS AND APPEARANCE
LIDOCAINE PAIN RELIEVING GEL-PATCH
lidocaine 4% patchProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:81533-201 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987) LIDOCAINE 4 g in 100 g Inactive Ingredients Ingredient Name Strength METHYLPARABEN (UNII: A2I8C7HI9T) POLYACRYLIC ACID (8000 MW) (UNII: 73861X4K5F) POLYSORBATE 80 (UNII: 6OZP39ZG8H) TARTARIC ACID (UNII: W4888I119H) SODIUM POLYACRYLATE (8000 MW) (UNII: 285CYO341L) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) WATER (UNII: 059QF0KO0R) GLYCERIN (UNII: PDC6A3C0OX) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) DIHYDROXYALUMINUM AMINOACETATE (UNII: DO250MG0W6) KAOLIN (UNII: 24H4NWX5CO) EDETATE SODIUM (UNII: MP1J8420LU) POVIDONE K90 (UNII: RDH86HJV5Z) PROPYLPARABEN (UNII: Z8IX2SC1OH) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:81533-201-05 5 in 1 BOX 02/28/2024 1 1 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 Drug M017 02/28/2024 Labeler - Noble OTC LLC (041836435) Registrant - Trifecta Pharmaceuticals USA, LLC. (079424163)