Label: PAIN RELIEF (menthol, unspecified form, methyl salicylate, and camphor- synthetic patch
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Contains inactivated NDC Code(s)
NDC Code(s): 71391-135-03 - Packager: Unexo Life Sciences, Private Limited
- Category: HUMAN OTC DRUG LABEL
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, 2021
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- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- ACTIVE INGREDIENT
- Uses
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Warnings
For External Use Only.
Do not use otherwise than as directed.
Ask Your Doctor Before Use if you have
- redness over the affected area
- have sensitive skin
- are pregnant or breast-feeding
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Directions
- For use by Adults and Children 12 years of age and older
- Apply to the affected area no more than 2 times a day
- Dry skin completely at application area, before applying the patch
- Open pouch and remove patch
- Peel of protective film and apply sticky side to affected area
- If applied on hairy skin, remove gently using mild warm water
- Patch once used, cannot be re-pasted or reused
- Dispose properly after use
- Children under 12 years of age, consult a doctor
- Other Information
- Inactive Ingredients
- SPL UNCLASSIFIED SECTION
- PRINCIPAL DISPLAY PANEL - 3 Patch Pouch
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INGREDIENTS AND APPEARANCE
PAIN RELIEF
menthol, unspecified form, methyl salicylate, and camphor (synthetic) patchProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:71391-135 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A) (MENTHOL, UNSPECIFIED FORM - UNII:L7T10EIP3A) MENTHOL, UNSPECIFIED FORM 78 mg METHYL SALICYLATE (UNII: LAV5U5022Y) (SALICYLIC ACID - UNII:O414PZ4LPZ) METHYL SALICYLATE 78 mg CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET) (CAMPHOR (SYNTHETIC) - UNII:5TJD82A1ET) CAMPHOR (SYNTHETIC) 78 mg Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:71391-135-03 3 in 1 POUCH; Type 0: Not a Combination Product 01/19/2019 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH NOT FINAL part348 01/19/2019 Labeler - Unexo Life Sciences, Private Limited (872260479) Establishment Name Address ID/FEI Business Operations Unexo Life Sciences, Private Limited 872260479 MANUFACTURE(71391-135)