Label: EAGLE BALM- camphor menthol ointment

  • NDC Code(s): 60954-010-01, 60954-010-19
  • Packager: Eagle Indo Pharma, PT
  • 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 July 29, 2021

If you are a consumer or patient please visit this version.

View All Sections
  • Active Ingredients

    Menthol 15%

    Camphor 11%

  • Purpose

    External Analgesic

    External Analgesic

  • Uses

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

  • Warnings

    For External Use Only

  • When using this product

    ■ Avoid getting itno the eyes or on mucous membranes ■do not apply to wounds or damaged skin ■do not bandage tightly or use with a heating pad ■do not use otherwise than as directed

  • Stop use and ask a doctor if

    ■Conditions worsens ■symptoms persist for more than 7 days or clear up and occur again within a few days ■redness is present

  • Keep out of reach of children

    In case of accidental ingestion contact a doctor or Poison Control Center immediately.

  • Directions

    ■ Adults and children 12 years of age: apply to affected area not more than 3 - 4 times daily. ■children under 12 years of age, consult a doctor before using

  • Other Information

    ■ Store in a a cool, dry place

  • Inactive Ingredients

    fragrance, paraffin, peppermint oil, petrolatum

  • Package Label

    package label

  • INGREDIENTS AND APPEARANCE
    EAGLE BALM 
    camphor menthol ointment
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:60954-010
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET) (CAMPHOR (SYNTHETIC) - UNII:5TJD82A1ET) CAMPHOR (SYNTHETIC)11 g  in 100 g
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL15 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    PARAFFIN (UNII: I9O0E3H2ZE)  
    PETROLATUM (UNII: 4T6H12BN9U)  
    PEPPERMINT OIL (UNII: AV092KU4JH)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:60954-010-011 in 1 BOX04/15/2019
    1NDC:60954-010-1919.8 g in 1 JAR; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34804/15/2019
    Labeler - Eagle Indo Pharma, PT (728682519)
    Establishment
    NameAddressID/FEIBusiness Operations
    Eagle Indo Pharma, PT728682519manufacture(60954-010)
View All Sections

Find additional resources

(also available in the left menu)

Safety

Report Adverse Events, FDA Safety Recalls, Presence in Breast Milk

Related Resources

Medline Plus, Clinical Trials, PubMed, Biochemical Data Summary

More Info on this Drug

View Labeling Archives, RxNorm, Get Label RSS Feed, View NDC Code(s)NEW!