Label: AMERIPATCH- menthol and capsaicin patch
- 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.
Updated November 18, 2015
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- ACTIVE INGREDIENTS:
- For external use only. Use only as directed. Avoid contact with eyes and mucous membranes.
- Do not cover with bandage.
- Do not use on wounds or damaged skin.
- Do not use if you are allergic to Menthol.
- Stop use and ask a doctor if conditions worsen, symptoms persist for more than 7 days or clear up and occur again within a few days.
- or a rash, itching or excessive skin irritation occurs.
- Adults and children 12 years and over apply to affected area; change patch 1 to 2 times daily.
- Children under 12 years, consult physician before use
- How to apply:
Clean and dry affected area
Cut open pouch and remove patch
Remove protective film and apply directly to area of pain
Apply to affected area not more than 3 times daily
Wash hands with soap after applying patch
Reseal pouch containing unused patches
- OTHER INGREDIENTS:
- Package Label - AmeriPatch (69418-003-15)
INGREDIENTS AND APPEARANCE
menthol and capsaicin patch
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:69418-003 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL 5 g in 100 g CAPSAICIN (UNII: S07O44R1ZM) (CAPSAICIN - UNII:S07O44R1ZM) CAPSAICIN 0.0375 g in 100 g Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) SODIUM POLYACRYLATE (2500000 MW) (UNII: 05I15JNI2J) PROPYLPARABEN (UNII: Z8IX2SC1OH) ALOE VERA LEAF (UNII: ZY81Z83H0X) EDETATE DISODIUM (UNII: 7FLD91C86K) DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4) METHYLPARABEN (UNII: A2I8C7HI9T) IODOPROPYNYL BUTYLCARBAMATE (UNII: 603P14DHEB) GLYCERIN (UNII: PDC6A3C0OX) POLYSORBATE 80 (UNII: 6OZP39ZG8H) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:69418-003-15 3 in 1 BOX 1 5 in 1 POUCH 1 15 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 01/31/2015 Labeler - Meds Direct Rx, Inc. (064053428) Establishment Name Address ID/FEI Business Operations Foshan Aqua Gel Biotech Co. Ltd 529128763 manufacture(69418-003)