Muscular Balm

Dosage form: ointment
Ingredients: Capsaicin 0.15g in 100g, Menthol 13.5g in 100g, Methyl Salicylate 30g in 100g
Labeler: Borden Company (Private) Limited
NDC Code: 43405-007

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.

Drug Facts

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 contact with mucus membranes and eyes.


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
  • 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


MUSCULAR BALM 
capsaicin menthol methyl salicylate ointment
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:43405-007
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Capsaicin (Capsaicin) Capsaicin0.15 g  in 100 g
Menthol (Menthol) Menthol13.5 g  in 100 g
Methyl Salicylate (Methyl Salicylate) Methyl Salicylate30 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
Eucalyptol 
Paraffin 
Petrolatum 
Packaging
#Item CodePackage Description
1NDC:43405-007-011 JAR (JAR) in 1 BOX
1NDC:43405-007-2020 g in 1 JAR
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34805/14/2010
Labeler - Borden Company (Private) Limited (595109711)
Establishment
NameAddressID/FEIOperations
PT Eagle Indo Pharmaceutical Laboratories 728682519manufacture

Revised: 12/2010
 
Borden Company (Private) Limited

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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