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NDC 60954-0010-01 Eagle Balm 11; 15 g/100g; g/100g Details

Eagle Balm 11; 15 g/100g; g/100g

Eagle Balm is a TOPICAL OINTMENT in the HUMAN OTC DRUG category. It is labeled and distributed by Eagle Indo Pharma, PT. The primary component is CAMPHOR (SYNTHETIC); MENTHOL.

Product Information

NDC	60954-0010
Product ID	60954-010_c8453b30-7103-5731-e053-2995a90a8eb6
Associated GPIs
GCN Sequence Number	n/a
GCN Sequence Number Description	n/a
HIC3	n/a
HIC3 Description	n/a
GCN	n/a
HICL Sequence Number	n/a
HICL Sequence Number Description	n/a
Brand/Generic	n/a
Proprietary Name	Eagle Balm
Proprietary Name Suffix	n/a
Non-Proprietary Name	Camphor Menthol
Product Type	HUMAN OTC DRUG
Dosage Form	OINTMENT
Route	TOPICAL
Active Ingredient Strength	11; 15
Active Ingredient Units	g/100g; g/100g
Substance Name	CAMPHOR (SYNTHETIC); MENTHOL
Labeler Name	Eagle Indo Pharma, PT
Pharmaceutical Class	n/a
DEA Schedule	n/a
Marketing Category	OTC MONOGRAPH NOT FINAL
Application Number	part348
Listing Certified Through	2024-12-31

Package

Package Images

NDC 60954-0010-01 (60954001001)

Pricing Information	N/A
NDC Package Code	60954-010-01
Billing NDC	60954001001
Package	1 JAR in 1 BOX (60954-010-01) / 19.8 g in 1 JAR (60954-010-19)
Marketing Start Date	2019-04-15
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL 87614869-9675-2c76-e053-2a95a90a48a9 Details

Active Ingredients

Menthol 15%

Camphor 11%

Purpose

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

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
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

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

#	Item Code	Package Description	Marketing Start Date
Packaging
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 Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part348	04/15/2019

Labeler - Eagle Indo Pharma, PT (728682519)

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

Revised: 7/2021

Document Id: c8453b30-7103-5731-e053-2995a90a8eb6

Set id: 87614869-9675-2c76-e053-2a95a90a48a9

Version: 2

Effective Time: 20210729