![FYZICAL SPORTS PAIN RELIEF 1-COOL (MENTHOL, CAPSAICIN) CREAM [S.P.O.R.T.S., LLC]](https://medic.hrt.org//dailymed/images/45c47849-9c9b-069b-e054-00144ff8d46c/Label5.jpg)
- DRUG FACTS
- Active Ingredients
- Indications:
For the temporary relief of minor aches and pains of the muscles and joints associated with arthritis, simple backache, sprains, bruises and strains.
Close - Warnings:
- For external use only.
- Avoid contact with eyes.
- If symptoms persist for more than seven days, discontinue use and consult physician.
CloseKeep out of reach of children.
- If swallowed, consult physician.
- Do not apply to wounds or damaged skin.
- Do not bandage tightly.
- 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.
Close - Additional Information:
- Package Labeling:
- INGREDIENTS AND APPEARANCE
FYZICAL SPORTS PAIN RELIEF 1-COOL
menthol, capsaicin creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:71178-775 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL 40 mg in 1 mL CAPSAICIN (UNII: S07O44R1ZM) (CAPSAICIN - UNII:S07O44R1ZM) CAPSAICIN 0.35 mg in 1 mL Inactive Ingredients Ingredient Name Strength CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO) ALLANTOIN (UNII: 344S277G0Z) ALOE VERA LEAF (UNII: ZY81Z83H0X) WATER (UNII: 059QF0KO0R) ARNICA MONTANA FLOWER (UNII: OZ0E5Y15PZ) INDIAN FRANKINCENSE (UNII: 4PW41QCO2M) BUTYLENE GLYCOL (UNII: 3XUS85K0RA) MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U) POLYOXYL 20 CETOSTEARYL ETHER (UNII: YRC528SWUY) CETYL ALCOHOL (UNII: 936JST6JCN) ETHYLHEXYLGLYCERIN (UNII: 147D247K3P) EUCALYPTUS OIL (UNII: 2R04ONI662) GLYCERIN (UNII: PDC6A3C0OX) GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4) HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER (100000 MPA.S AT 1.5%) (UNII: 86FQE96TZ4) ILEX PARAGUARIENSIS LEAF (UNII: 1Q953B4O4F) DIMETHYL SULFONE (UNII: 9H4PO4Z4FT) MINERAL OIL (UNII: T5L8T28FGP) PEG-100 STEARATE (UNII: YD01N1999R) PHENOXYETHANOL (UNII: HIE492ZZ3T) POLYSORBATE 20 (UNII: 7T1F30V5YH) POLYSORBATE 60 (UNII: CAL22UVI4M) ALMOND OIL (UNII: 66YXD4DKO9) SQUALANE (UNII: GW89575KF9) STEARIC ACID (UNII: 4ELV7Z65AP) TROLAMINE (UNII: 9O3K93S3TK) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) TROLAMINE SALICYLATE (UNII: H8O4040BHD) FD&C BLUE NO. 1 (UNII: H3R47K3TBD) FD&C RED NO. 40 (UNII: WZB9127XOA) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:71178-775-02 1 in 1 BOX 01/03/2017 1 60 mL in 1 TUBE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part348 01/03/2017 CloseLabeler - S.P.O.R.T.S., LLC (809986016)
