Label: TOPCARE HEALTH PAIN RELIEF- menthol, camphor, and methyl salicylate patch
- NDC Code(s): 36800-670-40
- 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 July 5, 2022
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- ACTIVE INGREDIENT
- PURPOSE
- WARNINGS
- DO NOT USE
- ASK DOCTOR
- WHEN USING
- STOP USE
- PREGNANCY OR BREAST FEEDING
- KEEP OUT OF REACH OF CHILDREN
- INDICATIONS & USAGE
- STORAGE AND HANDLING
- INACTIVE INGREDIENT
- DOSAGE & ADMINISTRATION
- PRINCIPAL DISPLAY PANEL
-
INGREDIENTS AND APPEARANCE
TOPCARE HEALTH PAIN RELIEF
menthol, camphor, and methyl salicylate patchProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:36800-670 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET) (CAMPHOR (SYNTHETIC) - UNII:5TJD82A1ET) CAMPHOR (SYNTHETIC) 0.012 mg in 1 g MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL 0.057 mg in 1 g METHYL SALICYLATE (UNII: LAV5U5022Y) (SALICYLIC ACID - UNII:O414PZ4LPZ) METHYL SALICYLATE 0.063 mg in 1 g Inactive Ingredients Ingredient Name Strength GLYCERYL ROSINATE (UNII: SD112V492J) NATURAL LATEX RUBBER (UNII: 2LQ0UUW8IN) PETROLATUM (UNII: 4T6H12BN9U) ZINC OXIDE (UNII: SOI2LOH54Z) POLYISOBUTYLENE (1000 MW) (UNII: 5XB3A63Y52) LANOLIN (UNII: 7EV65EAW6H) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:36800-670-40 40 in 1 CARTON 03/08/2022 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 not final part348 03/08/2022 Labeler - Topco Associates LLC (006935977)