Label: BUDPACK MUSCLE RUB- menthol gel

  • Category: HUMAN OTC DRUG LABEL

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 June 8, 2012

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  • ACTIVE INGREDIENT

    Active Ingredients
    Menthol 2.5%

  • PURPOSE

    Purpose
    Topical Analgesic

  • INDICATIONS & USAGE

    Uses ▪ Provides soothing relief of minor arthritis pain, aching muscles, joints and backache.

  • WARNINGS

    Warnings

    ▪ Avoid contact with eyes or mucous membranes. ▪ Discontinue use if excessive irritation of the skin develops. ▪ Do not bandage tightly, apply to wounds, broken or irritated skin, or use with a heating pad. ▪ If condition worsens, or if symptoms persist for more than 10 days or clear-up and occur again within a few days, if skin redness or irritation develops, discontinue use of this product and consult a doctor. For arthritis like conditions in children under 12, do not use. Consult a doctor.

  • KEEP OUT OF REACH OF CHILDREN

    ▪For external use only.Use only as directed. Keep out of the reach of children to avoid accidental poisoning.
    ▪If swallowed, get medical help or contact a Poison Control Center right away

  • DOSAGE & ADMINISTRATION

    Directions

    ▪ Adults and children12 years of age and older: apply to affected area not more than 3-4 times daily and gently massage until gel disappears. ▪ Children under 12 years of age: do not use, consult a doctor

  • SPL UNCLASSIFIED SECTION

    Other Information

    ▪Store at controlled room temperature 15 to 30C (59 to 86F) ▪ Lot No. Exp. Date: see box or see crimp of tube.

  • INACTIVE INGREDIENT

    Inactive Ingredients Camphor, Carbomer, DMDM Hydantoin, Isoceteth, Isopropyl Alcohol,PEG-40 Hydrogenated Castor Oil, Sodium Hydroxide and Water

  • PRINCIPAL DISPLAY PANEL

    Package Label
    image of package label


  • INGREDIENTS AND APPEARANCE
    BUDPACK  MUSCLE RUB
    menthol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:27293-030
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL2.5 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET)  
    DMDM HYDANTOIN (UNII: BYR0546TOW)  
    ISOPROPYL ALCOHOL (UNII: ND2M416302)  
    POLYOXYL 40 HYDROGENATED CASTOR OIL (UNII: 7YC686GQ8F)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:27293-030-3535 g in 1 TUBE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34806/30/2012
    Labeler - Budpack Inc. (183224849)
    Establishment
    NameAddressID/FEIBusiness Operations
    Ausmetics Daily Chemicals (Guangzhou) Co. Ltd.529836561manufacture
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