Label: ANALGESIC BALM ointment

  • 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 September 19, 2017

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  • Drug Facts

    Menthol-6%, Methyl Salicylate-14%
    Purpose: External analgesic

  • Uses

    For the temporary relief of
    minor aches and pain of muscles
    and joints.

  • Directions

    Adults and children
    2 years of age and older: Apply
    generously to affected area not
    more than 3 to 4 times daily.
    Children under 2 years of age:
    Consult a doctor.

  • DOSAGE & ADMINISTRATION

    Apply generously to affected area not
    more than 3 to 4 times daily.
    Children under 2 years of age:
    Consult a doctor.

  • WARNINGS

    Avoid contact with eyes or
    mucous membranes. Discontinue
    use if excessive irritation of the
    skin develops.
    • Do not: bandage tightly; apply
    to wounds, damaged skin, or
    use with a heating pad.
    • If condition worsens, or if
    symptoms persist more than
    7 days or clear-up and reoccur
    again within a few days,
    discontinue use of this product
    and consult a doctor. If
    swallowed, get medical help
    or contact a Poison Control
    Center immediately.

  • INACTIVE INGREDIENT

    Acylates Copolymer, DMDM Hydantoin,
    Lanolin, Paraffin Wax,
    Peg-40 Hydrogenated Castor Oil,
    Petrolatum, Phenoxyethanol, Water.

  • STORAGE

    At room temperature
    20º-25º C (68º-77º F). Close cap
    tightly after use.

  • OTC - KEEP OUT OF REACH OF CHILDREN

    Children under 2 years of age:
    Consult a doctor.

  • PRINCIPAL DISPLAY PANEL

    image description

  • INGREDIENTS AND APPEARANCE
    ANALGESIC BALM 
    analgesic balm ointment
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:54162-555
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL1.74 g  in 29 g
    METHYL SALICYLATE (UNII: LAV5U5022Y) (SALICYLIC ACID - UNII:O414PZ4LPZ) METHYL SALICYLATE4.06 g  in 29 g
    Inactive Ingredients
    Ingredient NameStrength
    DMDM HYDANTOIN (UNII: BYR0546TOW)  
    WATER (UNII: 059QF0KO0R)  
    LANOLIN (UNII: 7EV65EAW6H)  
    PARAFFIN (UNII: I9O0E3H2ZE)  
    POLYOXYL 40 HYDROGENATED CASTOR OIL (UNII: 7YC686GQ8F)  
    PETROLATUM (UNII: 4T6H12BN9U)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    CARBOMER COPOLYMER TYPE A (UNII: 71DD5V995L)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:54162-555-0129 g in 1 TUBE; Type 0: Not a Combination Product07/31/2015
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34803/09/2012
    Labeler - Geritrex LLC (112796248)
    Establishment
    NameAddressID/FEIBusiness Operations
    Geritrex LLC112796248manufacture(54162-555)
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