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NDC 60954-0001-01 Muscular Balm .15; 13.5; 30 g/100g; g/100g; g/100g Details

Muscular Balm .15; 13.5; 30 g/100g; g/100g; g/100g

Muscular 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 CAPSAICIN; MENTHOL; METHYL SALICYLATE.

Product Information

NDC	60954-0001
Product ID	60954-001_88900fb4-bb29-2736-e053-2995a90a9dda
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	Muscular Balm
Proprietary Name Suffix	n/a
Non-Proprietary Name	Capsaicin Menthol Methyl Salicylate
Product Type	HUMAN OTC DRUG
Dosage Form	OINTMENT
Route	TOPICAL
Active Ingredient Strength	.15; 13.5; 30
Active Ingredient Units	g/100g; g/100g; g/100g
Substance Name	CAPSAICIN; MENTHOL; METHYL SALICYLATE
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 60954-0001-01 (60954000101)

Pricing Information	N/A
NDC Package Code	60954-001-01
Billing NDC	60954000101
Package	1 JAR in 1 BOX (60954-001-01) / 20 g in 1 JAR (60954-001-20)
Marketing Start Date	2010-05-14
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL 888f88fc-dcaf-93e5-e053-2a95a90a20e1 Details

Active Ingredients

Capsaicin 0.15%

Menthol 13.5%

Methyl Salicylate 30%

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

■ Avoid getting into the eyes or on mucus membranes.

When using this product

■ do not apply to wound or damaged skin ■ do not bandage tightly ■ do not use if excessive irritation of the skin develops

■ do not use otherwise than as directed.

Stop use and ask a doctor if

■ condition worsens, or if symptoms persist for more than 7 days or clear up and occur again within a few days ■ pain persists for more than 10 days ■ redness is present ■ conditions affect children under 12 years of age

Keep out of reach of children

to avoid accidental poisoning. In case of accidental ingestion, contact a doctor or Poison Control Center Immediately

Directions

■ Adults and children 12 years of age and over: Apply to affected area not more than 3 to 4 time daily ■ Children under 12 years of age:consult a doctor

Inactive Ingredients

eucalyptol, fragrance, paraffin wax and petroleum jelly

Package Label

INGREDIENTS AND APPEARANCE

MUSCULAR BALM

capsaicin menthol methyl salicylate ointment

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:60954-001
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
CAPSAICIN (UNII: S07O44R1ZM) (CAPSAICIN - UNII:S07O44R1ZM)	CAPSAICIN	0.15 g in 100 g
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	13.5 g in 100 g
METHYL SALICYLATE (UNII: LAV5U5022Y) (SALICYLIC ACID - UNII:O414PZ4LPZ)	METHYL SALICYLATE	30 g in 100 g

Ingredient Name	Strength
Inactive Ingredients
EUCALYPTOL (UNII: RV6J6604TK)
PARAFFIN (UNII: I9O0E3H2ZE)
PETROLATUM (UNII: 4T6H12BN9U)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:60954-001-01	1 in 1 BOX	05/14/2010
1	NDC:60954-001-20	20 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	05/14/2010

Labeler - Eagle Indo Pharma, PT (728682519)

Name	Address	ID/FEI	Business Operations
Establishment
Eagle Indo Pharma, PT		728682519	manufacture(60954-001)

Revised: 5/2019

Document Id: 88900fb4-bb29-2736-e053-2995a90a9dda

Set id: 888f88fc-dcaf-93e5-e053-2a95a90a20e1

Version: 1

Effective Time: 20190510