Label: TOPCARE PAIN RELIEF PATCH- lidocaine, menthol patch
- NDC Code(s): 76162-007-05
- Packager: Topco Associates 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 January 12, 2022
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- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Active ingredients
- Purposes
- Use
- Warnings
- Do not use
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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 ask a doctor if
- If pregnant or breast-feeding,
- Keep out of reach of children and pets.
- Directions
- Inactive ingredients
- Package/Label Principal Display Panel
-
INGREDIENTS AND APPEARANCE
TOPCARE PAIN RELIEF PATCH
lidocaine, menthol patchProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:76162-007 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 MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A) (MENTHOL, UNSPECIFIED FORM - UNII:L7T10EIP3A) MENTHOL, UNSPECIFIED FORM 1 g in 100 g Inactive Ingredients Ingredient Name Strength DIHYDROXYALUMINUM AMINOACETATE ANHYDROUS (UNII: 1K713C615K) SODIUM POLYACRYLATE (2500000 MW) (UNII: 05I15JNI2J) POVIDONE, UNSPECIFIED (UNII: FZ989GH94E) GLYCERIN (UNII: PDC6A3C0OX) METHYLPARABEN (UNII: A2I8C7HI9T) KAOLIN (UNII: 24H4NWX5CO) POLYSORBATE 80 (UNII: 6OZP39ZG8H) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) POLYACRYLIC ACID (250000 MW) (UNII: 9G2MAD7J6W) TARTARIC ACID (UNII: W4888I119H) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) PROPYLPARABEN (UNII: Z8IX2SC1OH) WATER (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:76162-007-05 5 in 1 CARTON 01/01/2022 1 1 g in 1 POUCH; 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 01/01/2022 Labeler - Topco Associates LLC (006935977) Establishment Name Address ID/FEI Business Operations Foshan Aqua Gel Biotech Co., Ltd 529128763 manufacture(76162-007)