Label: PAIN RELIEF GEL-PATCH- lidocaine, menthol patch
- NDC Code(s): 83016-171-01, 83016-171-07
- Packager: R & Y Group, LLC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not final
DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
Drug Label Information
Updated June 15, 2023
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- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Active Ingredients
- Purpose
- Use
- Warnings
- Do not use
- When using this product
- Stop use and consult a doctor if
- If pregnant or breast-feeding,
- Keep out of reach of children.
- Directions
- Other Information
- Inactive Ingredients
- Package label. Principal display panel
-
INGREDIENTS AND APPEARANCE
PAIN RELIEF GEL-PATCH
lidocaine, menthol patchProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:83016-171 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL 0.12 g in 12 g LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987) LIDOCAINE 0.48 g in 12 g Inactive Ingredients Ingredient Name Strength KAOLIN (UNII: 24H4NWX5CO) TARTARIC ACID (UNII: W4888I119H) WATER (UNII: 059QF0KO0R) DIHYDROXYALUMINUM AMINOACETATE ANHYDROUS (UNII: 1K713C615K) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) POLYACRYLIC ACID (250000 MW) (UNII: 9G2MAD7J6W) SODIUM POLYACRYLATE (2500000 MW) (UNII: 05I15JNI2J) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) MINERAL OIL (UNII: T5L8T28FGP) POLYSORBATE 80 (UNII: 6OZP39ZG8H) GLYCERIN (UNII: PDC6A3C0OX) EDETATE DISODIUM (UNII: 7FLD91C86K) POVIDONE K90 (UNII: RDH86HJV5Z) HYDROXYACETOPHENONE (UNII: G1L3HT4CMH) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:83016-171-07 7 in 1 POUCH 06/15/2023 1 NDC:83016-171-01 12 g in 1 PACKET; 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 06/15/2023 Labeler - R & Y Group, LLC (968585765) Registrant - Shanghai Chuangshi Medical Technology (Group) Co., Ltd. (546872672) Establishment Name Address ID/FEI Business Operations Shanghai Chuangshi Medical Technology (Group) Co., Ltd. 546872672 manufacture(83016-171)