Label: FYZICAL SPORTS PAIN RELIEF- capsaicin cream

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not final

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.

Drug Label Information

Updated January 10, 2017

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  • 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, 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.

  • Additional Information:

    Store at room temperature.

  • Package Labeling:

    Label7

  • INGREDIENTS AND APPEARANCE
    FYZICAL SPORTS PAIN RELIEF 
    capsaicin cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71178-777
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CAPSAICIN (UNII: S07O44R1ZM) (CAPSAICIN - UNII:S07O44R1ZM) CAPSAICIN0.75 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    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)  
    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)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:71178-777-021 in 1 BOX01/04/2017
    160 mL in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34801/04/2017
    Labeler - S.P.O.R.T.S., LLC (809986016)
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