Label: CMC PAIN RELIEVING- .alpha.,.alpha.-dibromo-d-camphor, menthol, unspecified form, and capsaicin patch
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Contains inactivated NDC Code(s)
NDC Code(s): 71391-125-01, 71391-125-06 - Packager: Unexo Life Sciences, Private Limited
- 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 May 26, 2020
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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. Avoid contact with eyes.
Do not use
- On wounds or damaged skin
- With a bandage or heating pad
- On sensitive skin
- if allergic to any ingredient in this product
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Directions
- Adults and children 12 years of age and older: apply to the affected area not more than 3 to 4 times daily
- Children under 12 years of age consult a doctor
- clean and dry affected area
- remove patch from film
- apply sticky side of patch to affected area
- use one patch at a time
- leave patch on affected area for up to 8 hours at a time
- Other Information
- Inactive Ingredients
- Questions
- SPL UNCLASSIFIED SECTION
- PRINCIPAL DISPLAY PANEL - 6 Pouch Box
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INGREDIENTS AND APPEARANCE
CMC PAIN RELIEVING
.alpha.,.alpha.-dibromo-d-camphor, menthol, unspecified form, and capsaicin patchProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:71391-125 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength .ALPHA.,.ALPHA.-DIBROMO-D-CAMPHOR (UNII: F89Z8SAG3O) (.ALPHA.,.ALPHA.-DIBROMO-D-CAMPHOR - UNII:F89Z8SAG3O) .ALPHA.,.ALPHA.-DIBROMO-D-CAMPHOR 129.6 mg MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A) (MENTHOL, UNSPECIFIED FORM - UNII:L7T10EIP3A) MENTHOL, UNSPECIFIED FORM 54 mg CAPSAICIN (UNII: S07O44R1ZM) (CAPSAICIN - UNII:S07O44R1ZM) CAPSAICIN 1.08 mg Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:71391-125-01 1 in 1 POUCH; Type 0: Not a Combination Product 06/01/2020 2 NDC:71391-125-06 6 in 1 BOX 06/01/2020 2 1 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 06/01/2020 Labeler - Unexo Life Sciences, Private Limited (872260479) Establishment Name Address ID/FEI Business Operations Unexo Life Sciences, Private Limited 872260479 MANUFACTURE(71391-125)