EAGLE BALM- camphor menthol ointment

Eagle Balm by

Drug Labeling and Warnings

Eagle Balm by is a Otc medication manufactured, distributed, or labeled by Eagle Indo Pharma, PT. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

INGREDIENTS AND APPEARANCE

EAGLE BALM 
camphor menthol ointment

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 60954-010
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET) (CAMPHOR (SYNTHETIC) - UNII:5TJD82A1ET)	CAMPHOR (SYNTHETIC)	11 g  in 100 g
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	15 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
PARAFFIN (UNII: I9O0E3H2ZE)
PETROLATUM (UNII: 4T6H12BN9U)
PEPPERMINT OIL (UNII: AV092KU4JH)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 60954-010-01	1 in 1 BOX	04/15/2019
1	NDC: 60954-010-19	19.8 g in 1 JAR; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	04/15/2019

Labeler - Eagle Indo Pharma, PT (728682519)

Establishment
Name	Address	ID/FEI	Business Operations
Eagle Indo Pharma, PT		728682519	manufacture(60954-010)