Label: BANALG- methyl salicylate lotion

  • 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 February 15, 2011

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  • Active ingredient

    Methyl Salicylate 14.0%

    Menthol 3.0%

  • PURPOSE

  • Keep Out of Reach of Children

  • Uses

    For the temporary relief of minor ach3es and pains of muscles and joints associated with arthritis and rheumatism. Also good for simple backache, strains and sprains.

  • Warnings

    Use only as directed. If pain persists more than 10 days, or redness is present, or in conditions affecting children under 12 years of age, consult your physician immediately. Discontinue use if excessive irritation of the skin develops. Avoid getting into the eyes or on mucous membranes.

    For external use only. Use only as directed. Do not apply to wounds, broken or irritated skin. Do not use with a heating pad. Do not bandage tightly.

    If swallowed, induce vomiting and contact a physician or poison control center immediately.

  • Directions

    Apply fast vanishing lotion with gentle massage to affected area not more than 3 to 4 times daily.

  • INACTIVE INGREDIENT

  • Package/Label Principal Display Panel

    Banalg Hospital Strength

  • INGREDIENTS AND APPEARANCE
    BANALG 
    methyl salicylate lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:21695-440(NDC:0456-0525)
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    METHYL SALICYLATE (UNII: LAV5U5022Y) (METHYL SALICYLATE - UNII:LAV5U5022Y) METHYL SALICYLATE140 mg  in 1 g
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL30 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    1,3-DIMETHYLBUTYL SALICYLATE (UNII: 47OL39K42M)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:21695-440-0260 g in 1 BOTTLE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34801/01/2007
    Labeler - Rebel Distributors Corp (118802834)
    Establishment
    NameAddressID/FEIBusiness Operations
    Rebel Distributors Corp118802834RELABEL, REPACK
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