Label: EAGLE BRAND MEDICATED OIL AROMATIC- camphor, menthol, methyl salicylate oil

  • NDC Code(s): 60954-014-24, 60954-014-36
  • Packager: PT. EAGLE INDO PHARMA
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated May 13, 2024

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  • Active Ingredients

    • Camphor 7%
    • Menthol 16%
    • Methyl Salicylate 35%
  • Purpose

    External Analgesic

  • Uses

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

  • Warnings

    For external use only

    When using this product

    • Avoid getting into the eyes or on mucous membranes.
    • Do not apply to wounds or damaged skin.
    • Do not bandage tightly.
    • Do not use otherwise than as directed.

    Stop use and ask doctor if

    Condition worsens, or if symptoms persist for more than 7 days or clear up and occur again within a few days, discontinue use of this product and consult a doctor.

    If pregnant or breast-feeding

    Ask a health professional before use.

    Keep out of reach of children

    If swallowed, get medical help or contact a Poison Control Centre right away.

  • Directions

    • 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: do not use, consult a doctor.

  • Other Information

    Store below 86 oF (30 oC).

  • Inactive Ingredients

    eucalyptus oil, light mineral oil, lavender spike oil

  • Questions?

    If there are any questions or to report serious side effects, call 1-800-777-6717 or 1-800-645-0769.

  • Package Label

    24ml NDC: 60954-014-24

    24ml Unit Box

    36ml NDC: 60954-014-36

    36ml Unit Box

  • INGREDIENTS AND APPEARANCE
    EAGLE BRAND  MEDICATED OIL AROMATIC
    camphor, menthol, methyl salicylate oil
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:60954-014
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL16 g  in 100 mL
    METHYL SALICYLATE (UNII: LAV5U5022Y) (SALICYLIC ACID - UNII:O414PZ4LPZ) METHYL SALICYLATE35 g  in 100 mL
    CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET) (CAMPHOR (SYNTHETIC) - UNII:5TJD82A1ET) CAMPHOR (SYNTHETIC)7 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    LIGHT MINERAL OIL (UNII: N6K5787QVP)  
    EUCALYPTUS OIL (UNII: 2R04ONI662)  
    SPIKE LAVENDER OIL (UNII: 7S2HYV1VJQ)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:60954-014-241 in 1 BOX11/01/2023
    124 mL in 1 BOTTLE, GLASS; Type 0: Not a Combination Product
    2NDC:60954-014-361 in 1 BOX11/01/2023
    236 mL in 1 BOTTLE, GLASS; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01711/01/2023
    Labeler - PT. EAGLE INDO PHARMA (728682519)
    Establishment
    NameAddressID/FEIBusiness Operations
    PT. EAGLE INDO PHARMA728682519manufacture(60954-014)
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