Label: MENTHOL, CAPSAICIN- vitacin 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 August 30, 2016
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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 in combination with any other external analgesic products.
- 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.
If swallowed, get a medical help or contact Poison Control Center right away.
- Adults and children 12 years and over apply to affected area; change patch 1 to 2 times daily.
- Children under 12years, consult physician before use
- Clean and dry affected area
- 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
- INACTIVE INGREDIENTS
- Storage and Handling
- Questions or Comments
- DOSAGE & ADMINISTRATION
- VitaCin Patch
INGREDIENTS AND APPEARANCE
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:69677-011 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength CAPSAICIN (UNII: S07O44R1ZM) (CAPSAICIN - UNII:S07O44R1ZM) CAPSAICIN 0.375 mg in 1 g MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL 50 mg in 1 g Inactive Ingredients Ingredient Name Strength EDETATE DISODIUM (UNII: 7FLD91C86K) DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4) WATER (UNII: 059QF0KO0R) GLYCERIN (UNII: PDC6A3C0OX) METHYLPARABEN (UNII: A2I8C7HI9T) PROPYLPARABEN (UNII: Z8IX2SC1OH) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:69677-011-15 15 in 1 BOX 09/01/2016 1 8 g in 1 PATCH; Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.) Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part348 09/01/2016 Labeler - MAS Management Group Inc. (079363782) Establishment Name Address ID/FEI Business Operations MAS MANAGEMENT GROUP INC. 079363782 label(69677-011)