Label: REACTHEAT HEAT BAUME- menthol, capsicum annum extract cream

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph 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 27, 2012

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  • ACTIVE INGREDIENT

    Active Ingredients                Purpose

    Menthol (5%)                       External Analgesic

    Capsicum Annum Extract (0.5)     External Analgesic

    Uses

    For temporary relief of minor aches and pains of muscles such as: simple backache, lumbago, arthritis, neuralgia, strains, bruises and sprains.

    Keep out of reach of children


    Consult a doctor and discontinue use if condition worsens or persists for more than 7 days.

    For external use only. When using this product, avoid contact with eyes. Wash hands completely after each use. If swallowed seek medical assistance immediately or contact poison control. If you are pregnant or nursing, seeking the advice of your doctor before using this product.

    Directions for use

    Apply cream to sore muscles and joints and massage into skin as needed. For adults and children 2 years of age and older apply to affected area no more than 3 to 4 times daily. Children under 2 years of age consult a doctor.

    Water, DImethyl Sulfone, Clove Bud Oil, Peppermint Oil, Eucalyptus Oil, Aloe vera, Ascorbic Acid, Tocopherol, Glycine, Wintergreen Oil, Jojoba Oil, Arnica Montana Flower Extract, Polyarylamide, C13-14 Isoparaffin, Laureth 7, Sodium Hydroxymethylglycinate, glycerol.



    image of back label
  • PRINCIPAL DISPLAY PANEL



    Reactheat
    Reactivating Heat Baume

    4 fl. oz./ 118.29ml






    image of front label

  • INGREDIENTS AND APPEARANCE
    REACTHEAT  HEAT BAUME
    menthol, capsicum annum extract cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:75963-126
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL5 mL  in 100 mL
    BIRD PEPPER (UNII: JLH5RT8O28) (BIRD PEPPER - UNII:JLH5RT8O28) BIRD PEPPER0.5 mL  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    DIMETHYL SULFONE (UNII: 9H4PO4Z4FT)  
    CLOVE OIL (UNII: 578389D6D0)  
    PEPPERMINT OIL (UNII: AV092KU4JH)  
    EUCALYPTUS OIL (UNII: 2R04ONI662)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    ASCORBIC ACID (UNII: PQ6CK8PD0R)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    GLYCINE (UNII: TE7660XO1C)  
    JOJOBA OIL (UNII: 724GKU717M)  
    ARNICA MONTANA FLOWER (UNII: OZ0E5Y15PZ)  
    C13-14 ISOPARAFFIN (UNII: E4F12ROE70)  
    LAURETH-7 (UNII: Z95S6G8201)  
    SODIUM HYDROXYMETHYLGLYCINATE (UNII: DIG6BWZ9XT)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:75963-126-01118 mL in 1 BOTTLE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34808/20/2011
    Labeler - Rejuventus (032186703)
    Registrant - Rejuventus (032186703)
    Establishment
    NameAddressID/FEIBusiness Operations
    RWM techologies003215779manufacture
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