Label: CMX TOPICAL PAIN- menthol, capsaicin patch
- NDC Code(s): 69889-027-15
- Packager: Unik 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 February 10, 2017
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- DRUG FACTS:
- Active Ingredient:
• For external use only. Use only as directed.
• Avoid contact with eyes and mucous membranes.
• Do not apply to open wounds or damaged skin.
Do not use
• in combination with any external heat source.
• 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 allergic to Menthol.
Stop use and consult physician
• if symptoms worsen or persist for more than 7 days.
• Stop use if itching to excessive skin irritation occurs.
• Adults and children 12-years and over: Apply to affected area; change patch 1-2 times daily.
• Children under 12, consult a physician before use.
• How to Apply:
• Clean and dry affected area.
• Remove patch from backing and apply directly to area of pain.
• Do not apply to affected area more than three times daily.
• Use only on patch at a time.
• Wash hands with soap and water immediately after application.
• Reseal pouch containing unused patches.
- Other Ingredients:
- Store at room temperature.
- Package Labeling:
INGREDIENTS AND APPEARANCE
CMX TOPICAL PAIN
menthol, capsaicin patch
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:69889-027 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:69889-027-15 15 in 1 BOX 09/15/2016 1 8 g in 1 PACKAGE; 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 09/15/2016 Labeler - Unik Pharmaceuticals, Inc (079835464)