FDA Label for Menthol, Capsaicin
View Indications, Usage & Precautions
Menthol, Capsaicin Product Label
The following document was submitted to the FDA by the labeler of this product Mas Management Group Inc.. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
Active Ingredients
Menthol 5%
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
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