FDA Label for Frankie Avalons Zero Pain Roll-on Pain Reliever

View Indications, Usage & Precautions

Frankie Avalons Zero Pain Roll-on Pain Reliever Product Label

The following document was submitted to the FDA by the labeler of this product Why Enterprises Llc. 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.

Drug Facts:




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:




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