MUSCULAR BALM- capsaicin menthol methyl salicylate 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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Drug Facts

Active Ingredients

Capsaicin 0.15%
Menthol 13.5%
Methyl Salicylate 30%


Purpose

External Analgesic

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

■ 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

Package Label

MUSCULAR BALM 
capsaicin menthol methyl salicylate ointment
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:60954-001
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CAPSAICIN (UNII: S07O44R1ZM) (CAPSAICIN - UNII:S07O44R1ZM) CAPSAICIN0.15 g  in 100 g
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL13.5 g  in 100 g
METHYL SALICYLATE (UNII: LAV5U5022Y) (SALICYLIC ACID - UNII:O414PZ4LPZ) METHYL SALICYLATE30 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
EUCALYPTOL (UNII: RV6J6604TK)  
PARAFFIN (UNII: I9O0E3H2ZE)  
PETROLATUM (UNII: 4T6H12BN9U)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:60954-001-011 in 1 BOX05/14/2010
1NDC:60954-001-2020 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 finalpart34805/14/2010
Labeler - Eagle Indo Pharma, PT (728682519)
Establishment
NameAddressID/FEIBusiness Operations
Eagle Indo Pharma, PT728682519manufacture(60954-001)

Revised: 5/2019
Document Id: 88900fb4-bb29-2736-e053-2995a90a9dda
Set id: 888f88fc-dcaf-93e5-e053-2a95a90a20e1
Version: 1
Effective Time: 20190510
 
Eagle Indo Pharma, PT