EAGLE BALM- camphor menthol ointment 
Eagle Indo Pharma, PT

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.

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Eagle Balm Pharma

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

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)

Revised: 7/2021
Document Id: c8453b30-7103-5731-e053-2995a90a8eb6
Set id: 87614869-9675-2c76-e053-2a95a90a48a9
Version: 2
Effective Time: 20210729
 
Eagle Indo Pharma, PT