País: Estados Unidos
Idioma: inglés
Fuente: NLM (National Library of Medicine)
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A), CAPSAICIN (UNII: S07O44R1ZM) (CAPSAICIN - UNII:S07O44R1ZM)
S.P.O.R.T.S., LLC
TOPICAL
OTC DRUG
For the temporary relief of minor aches and pains of the muscles and joints associated with arthritis, simple backache, sprains, bruises and strains.
OTC monograph not final
FYZICAL SPORTS PAIN RELIEF 1-COOL- MENTHOL, CAPSAICIN CREAM S.P.O.R.T.S., LLC _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._ ---------- FYZICAL SPORTS PAIN RELIEF CREAM 1-COOL _DRUG FACTS_ _ACTIVE INGREDIENTS_ Menthol 4.00% Capsaicin 0.035% _PURPOSE_ Topical Analgesic INDICATIONS : For the temporary relief of minor aches and pains of the muscles and joints associated with arthritis, simple backache, sprains, bruises and strains. _WARNINGS:_ FOR EXTERNAL USE ONLY. Avoid contact with eyes. If symptoms persist for more than seven days, discontinue use and consult physician. KEEP OUT OF REACH OF CHILDREN. If swallowed, consult physician. Do not apply to wounds or damaged skin. Do not bandage tightly. IF PREGNANT OR BREAST FEEDING, contact physician prior to use. _DIRECTIONS:_ Adults and children two-years of age or older:Apply to affected area not more than three to four times daily, Children under two-years of age: consult a physician. _OTHER INGREDIENTS:_ Acrylates/c10-30 Alkyl Acrylate Crosspolymer, Allantoin, Aloe Barbadensis Leaf (Aloe Vera Gel) Juice, Aqua (Deionized Water), Arnica Montana Flower Extract, Boswellia Serrata Extract, Butylene Glycol, Caprylic/Capric Triglyceride, Ceteareth-20, Cetyl Alcohol, Ethylhexylglycerin, Eucalyptus Globulus Oil, Glycerin, Glyceryl Stearate, Hydroxyethyl Acrylate/Sodium Acryloyldimethyl Taurate Copolymer, Iles Paraguayensis (Yerba Mate) Extract, Methylsulfonylmethane (MSM), Mineral Oil, PEG-100 Stearate, Phenoxyethanol, Polysorbate-20, Polysorbate-60, Prunus Amygdalus Dulcis (Sweet Almond) Oil, Squalane, Stearic Acid, Triethanolamine, Tocopheryl Acetate (Vitamin E), Trolamine Salicylate, FD&C Blue #1, FD&C Red #40. _ADDITIONAL INFORMATION:_ Store at room temperature. PACKAGE LABELING: FYZICAL SPORTS PAIN RELIEF 1-COOL menthol, capsaicin cream PRODUCT INFORMATION PRODUCT T YPE HUMAN OTC DRUG ITE M CODE (SOURCE ) NDC: Leer el documento completo