Active Ingredients
Menthol 5%
Menthol, Capsaicin
FDA Label NDC 69677-011
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Mas Management Group Inc. for the product Menthol, Capsaicin (NDC 69677-011). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding active ingredients, purpose, uses, warnings, keep out of reach of children, pregnancy or breast feeding, directions, inactive ingredients, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
External Analgesic
Uses
For the temporary relief of minor aches and pains of the muscles and joints associated with simple backache, arthritis, sprains, bruises and strains.
Warnings
- 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.
Pregnancy Or Breast Feeding
If pregnant or breast-feeding, ask a health professional before use.
Directions
- 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
WATER, GLYCERINE, SODIUM POLYACRYLATE, POLYSORBATE 80, ALOE BARBADESIS LEAF (ALOE VERA
GEL) JUICE, EDTA DISODIUM SALT, DIAZOLIDINYL UREA, METHYLPARABEN, LODOPROYNYL BUTYLCABAMATE, PROPYLPARABEN.
Storage And Handling
Store in dry area between 59-79 F(15-26 C)
Questions Or Comments
Please call (800) 768-3518
Dosage & Administration
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.
Vitacin Patch
Vitacin Patch (69677 011 15 Vitacin Patches)
* Please review the disclaimer below.
