Label: NUDROXICIN- menthol, capsaicin patch
- NDC Code(s): 70859-022-15
- Packager: NuCare Pharmaceuticals, Inc.
- 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 October 11, 2019
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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
- Do not use in combination with and other external analgesic products.
- Avoid contact with eyes and mucous membranes.
- Do not use on irritated or broken skin, or use in combination with any bandage, wrap, stocking or similar device or garment.
Keep out of reach of children.
- Consult physician for children under 12.
- Do not use 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 area of pain
- Apply to affected area not more than 3 times daily
- wash hands with soap after applying patch
- Reseal pouch containing unused patched
- OTHER INGREDIENTS
- Package Labeling:
INGREDIENTS AND APPEARANCE
menthol, capsaicin patch
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:70859-022 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL 50 mg in 1 g CAPSAICIN (UNII: S07O44R1ZM) (CAPSAICIN - UNII:S07O44R1ZM) CAPSAICIN 0.375 mg in 1 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:70859-022-15 15 in 1 CARTON 08/16/2017 1 10 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 08/16/2017 Labeler - NuCare Pharmaceuticals, Inc. (010632300) Establishment Name Address ID/FEI Business Operations NuCare Pharmaceuticals, Inc. 010632300 repack(70859-022) , relabel(70859-022) Establishment Name Address ID/FEI Business Operations Pure Source, LLC 080354456 manufacture(70859-022)