Label: THERACARE PAIN RELIEVING PATCH WITH LIDOCAINE- lidocaine patch
- NDC Code(s): 71101-918-12
- Packager: Veridian Healthcare
- 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 April 13, 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
- 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 or 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
- Other Information
- Inactive Ingredients
- TheraCare Pain Relieving Patch with Lidocaine
-
INGREDIENTS AND APPEARANCE
THERACARE PAIN RELIEVING PATCH WITH LIDOCAINE
lidocaine patchProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:71101-918 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 GLYCERIN (UNII: PDC6A3C0OX) POLYSORBATE 80 (UNII: 6OZP39ZG8H) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) POVIDONE (UNII: FZ989GH94E) ETHYLHEXYLGLYCERIN (UNII: 147D247K3P) TARTARIC ACID (UNII: W4888I119H) KAOLIN (UNII: 24H4NWX5CO) IODOPROPYNYL BUTYLCARBAMATE (UNII: 603P14DHEB) WATER (UNII: 059QF0KO0R) POLYACRYLIC ACID (8000 MW) (UNII: 73861X4K5F) CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311) SODIUM POLYACRYLATE (8000 MW) (UNII: 285CYO341L) DIHYDROXYALUMINUM AMINOACETATE (UNII: DO250MG0W6) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) PETROLATUM (UNII: 4T6H12BN9U) PHENOXYETHANOL (UNII: HIE492ZZ3T) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:71101-918-12 1 g in 1 POUCH; Type 0: Not a Combination Product 04/01/2023 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part348 04/01/2023 Labeler - Veridian Healthcare (830437997) Establishment Name Address ID/FEI Business Operations Foshan Aqua Gel Biotech Co., Ltd. 529128763 manufacture(71101-918)