Frankie Avalons Zero Pain Roll-on Pain Reliever Liquid
FDA Label NDC 84413-481
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Why Enterprises Llc for the product Frankie Avalons Zero Pain Roll-on Pain Reliever (NDC 84413-481). 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 drug facts:, active ingredient, uses:, warnings:, keep out of reach of children, directions:, other information:, other ingredients:, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Active Ingredient
Capsaicin 0.025%
Uses:
For the temporary relief of minor aches and pains of muscles and joints associated with simple backache, arthritis, strains, bruises, and sprains.
Warnings:
For external use only. Avoid contact with the eyes. If condition worsens, or if symptoms persist for more than 7 days, or clear up and occur again within a few days, discontinue use of this product and consult a doctor. Do not apply to wounds or damaged skin. Do not bandage tightly.
Keep Out Of Reach Of Children
Directions:
Adults and children 2 years of age and older: Apply to affected area not more than 3 to 4 times daily. Children under 2 years of age: consult a doctor.
Other Information:
Products containing capsaicin may cause a burning, stinging or tingling sensation where applied. This is a natural reaction and varies with each individual and usually decreases or disappears after continued use. Read all information on the box and the opposite panel before use.
Other Ingredients:
Aloe Barbadensis Leaf (Aloe Vera Gel) Juice, Aqua (Deionized Water), Arnica Montana (Arnica) Extract, Boswella Serrata Extract, C13-14 Isoparaffin, Chamomilla Recutitta (Chamomile) Extract, Cimicifuga Racemosa (Black Cohosh) Extract, DMDM Hydantoin, Glycerin, Hydrastis Canadensis (Goldenseal) Root Extract, Isopropyl Alcohol, Laureth-7, Medicago Sativa (Alfalfa) Extract, Polyacrylamide, Polysorbate-20, Yucca Schidegera Extract.
Package Labeling:
Label (Label)
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