MUSCULAR BALM- capsaicin menthol methyl salicylate ointment

Muscular Balm by

Drug Labeling and Warnings

Muscular Balm by is a Otc medication manufactured, distributed, or labeled by Borden Company (Private) Limited. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredients

Capsaicin 0.15%
Menthol 13.5%
Methyl Salicylate 30%

Purpose

External Analgesic

External Analgesic

External Analgesic

Use

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 mucous membranes.

When using this product

■ do not apply to wounds 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: 43405-007
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
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

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

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 43405-007-01	1 in 1 BOX	05/14/2010
1	NDC: 43405-007-20	20 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	05/14/2010

Labeler - Borden Company (Private) Limited (595109711)