Label: PAINKOOLERS- menthol, capsaicin patch
- NDC Code(s): 65121-828-05
- Packager: Pure Source, 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.
Updated November 12, 2021
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- DRUG FACTS
- 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.
- in combination with any other external analgesic products.
- in combination with any external heat source.
- on irritated or broken skin, or use in combination with any bandage, wrap, stocking or similar device or garment.
- if you are allergic to Menthol.
- 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 the area of pain
- Apply to affected area not more than 3 times daily
- Wash hands with soap after applying patch
- Reseal pouch containing unsed patches
- OTHER INGREDIENTS:
- Product Label
INGREDIENTS AND APPEARANCE
menthol, capsaicin patch
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:65121-828 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) GLYCERIN (UNII: PDC6A3C0OX) POLYSORBATE 80 (UNII: 6OZP39ZG8H) ALOE VERA LEAF (UNII: ZY81Z83H0X) EDETATE DISODIUM (UNII: 7FLD91C86K) DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4) METHYLPARABEN (UNII: A2I8C7HI9T) IODOPROPYNYL BUTYLCARBAMATE (UNII: 603P14DHEB) PROPYLPARABEN (UNII: Z8IX2SC1OH) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:65121-828-05 5 in 1 BOX 02/10/2017 1 8 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 12/30/2014 Labeler - Pure Source, LLC (080354456)