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Reactheat (Rejuventus)

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CREAM 118 mL in 1 BOTTLE (75963-126-01) Label Information

Complete Reactheat Information

  • 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.



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  • 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 Type HUMAN OTC DRUG Item Code (Source) NDC:75963-126
    Route of Administration TOPICAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL 5 mL  in 100 mL
    BIRD PEPPER (UNII: JLH5RT8O28) (BIRD PEPPER - UNII:JLH5RT8O28) BIRD PEPPER 0.5 mL  in 100 mL
    Inactive Ingredients
    Ingredient Name Strength
    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 Code Package Description Marketing Start Date Marketing End Date
    1 NDC:75963-126-01 118 mL in 1 BOTTLE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph final part348 08/20/2011
    Labeler - Rejuventus (032186703)
    Registrant - Rejuventus (032186703)
    Establishment
    Name Address ID/FEI Business Operations
    RWM techologies 003215779 manufacture