FYZICAL SPORTS PAIN RELIEF 2 MILD (CAPSAICIN) CREAM [PENSIVY SPORTS PRODUCTS LLC]

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FYZICAL SPORTS PAIN RELIEF 2 MILD (CAPSAICIN) CREAM [PENSIVY SPORTS PRODUCTS LLC]
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NDC 71178-776-02
Set ID 45c4567d-786c-6459-e054-00144ff88e88
Category HUMAN OTC DRUG LABEL
Packager Pensivy Sports Products LLC
Generic Name
Product Class
Product Number
Application Number PART348
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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:

    Label6

  • INGREDIENTS AND APPEARANCE
    FYZICAL SPORTS PAIN RELIEF 2 MILD 
    capsaicin cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71178-776
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CAPSAICIN (UNII: S07O44R1ZM) (CAPSAICIN - UNII:S07O44R1ZM) CAPSAICIN0.35 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:71178-776-021 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 - Pensivy Sports Products LLC (809986016)
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