Label: ACTIBEAU SPORTS MASSAGE- niacinamide, adenosine gel

  • 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 April 1, 2019

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  • ACTIVE INGREDIENT

    Menthol 3.5%

    Camphor 0.5%


  • PURPOSE

    Topical Analgesic

  • INDICATIONS & USAGE

    For temporary relief of minor aches and pains of
    muscles and joints associated with • simple backache • arthritis • strains• bruises • sprains

  • DOSAGE & ADMINISTRATION

    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.

  • WARNINGS


    For external use only

    Flammable keep away from fire or flame

    When using this product, • avoid contact with eyes or mucous membranes • do not bandage tightly • do not apply to wound or damaged or irritated skin

    Stop use and consult a doctor if • condition worsens • symptoms persist for more than 7 days • clear up and occur again within a few days
    If pregnant or breast-feeding, ask a health professional before use

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of the children. If product is swallowed, get medical help or contact a poison control center right away.

  • INACTIVE INGREDIENT

    Water, Isopropyl Alcohol, Glycerin, Glycyrrhiza Glabra Root Extract, Methyl sulfonyl methane, Carbomer, PEG-60 Hydrogenated Caster Oil, Methylparaben, Sodium Hydroxide, FD&C blue No. 1, Flavoring

  • PRINCIPAL DISPLAY PANEL

    image description

  • INGREDIENTS AND APPEARANCE
    ACTIBEAU SPORTS MASSAGE 
    niacinamide, adenosine gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:73016-002
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL, UNSPECIFIED FORM4.2 g  in 120 g
    CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET) (CAMPHOR (SYNTHETIC) - UNII:5TJD82A1ET) CAMPHOR (SYNTHETIC)0.6 g  in 120 g
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    ISOPROPYL ALCOHOL (UNII: ND2M416302)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    GLYCYRRHIZA GLABRA (UNII: 2788Z9758H)  
    DIMETHYL SULFONE (UNII: 9H4PO4Z4FT)  
    CARBOXYPOLYMETHYLENE (UNII: 0A5MM307FC)  
    PEG-60 HYDROGENATED CASTOR OIL (UNII: 02NG325BQG)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:73016-002-021 in 1 CARTON04/01/2019
    1NDC:73016-002-01120 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34804/01/2019
    Labeler - ACTIVEBEUTY CO.,LTD. (695911007)
    Registrant - ACTIVEBEUTY CO.,LTD. (695911007)
    Establishment
    NameAddressID/FEIBusiness Operations
    JJindustry.Co.Ltd689605084manufacture(73016-002)
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