Label: REACTICE REACTIVATING ICE BAUME- menthol 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 27, 2012

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  • ACTIVE INGREDIENT

    Active ingredients              Purpose

    Menthol (5%)                   External Analgesic        

    Uses

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

    Keep out of reach of children

    Consult a doctor and discontinue use if conditions worsen or persist 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,seek 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 not 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, Polyacrylamide, C13-14 Isoparaffin, Laureth 7, Sodium Hydroxymethylglycinate, glycerol.





    image of back label



  • PRINCIPAL DISPLAY PANEL

    Reactice

    Reactivating Ice Baume

    external analgesic

    16 fl oz./473ml






    image of front label

  • INGREDIENTS AND APPEARANCE
    REACTICE  REACTIVATING ICE BAUME
    menthol cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:75963-125
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL118.29 mL  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    DIMETHYL SULFONE (UNII: 9H4PO4Z4FT)  
    CLOVE (UNII: K48IKT5321)  
    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:75963-125-01118.29 mL in 1 JAR
    2NDC:75963-125-02473 mL in 1 JAR
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34807/21/2011
    Labeler - Rejuventus, Inc. (032186703)
    Registrant - Rejuventus, Inc. (032186703)
    Establishment
    NameAddressID/FEIBusiness Operations
    Rwm Technologies003215779manufacture
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