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Analgesic Balm

Dosage form: ointment
Ingredients: MENTHOL 1.74g in 29g, METHYL SALICYLATE 4.06g in 29g
Labeler: Geritrex LLC
NDC Code: 54162-555

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.

Analgesic Balm

Drug Facts

Menthol-6%, Methyl Salicylate-14%
Purpose: External analgesic

Uses

For the temporary relief of
minor aches and pain of muscles
and joints.

Directions

Adults and children
2 years of age and older: Apply
generously to affected area not
more than 3 to 4 times daily.
Children under 2 years of age:
Consult a doctor.

Apply generously to affected area not
more than 3 to 4 times daily.
Children under 2 years of age:
Consult a doctor.

WARNINGS

Avoid contact with eyes or
mucous membranes. Discontinue
use if excessive irritation of the
skin develops.
• Do not: bandage tightly; apply
to wounds, damaged skin, or
use with a heating pad.
• If condition worsens, or if
symptoms persist more than
7 days or clear-up and reoccur
again within a few days,
discontinue use of this product
and consult a doctor. If
swallowed, get medical help
or contact a Poison Control
Center immediately.

INACTIVE INGREDIENT

Acylates Copolymer, DMDM Hydantoin,
Lanolin, Paraffin Wax,
Peg-40 Hydrogenated Castor Oil,
Petrolatum, Phenoxyethanol, Water.

STORAGE

At room temperature
20º-25º C (68º-77º F). Close cap
tightly after use.

OTC - KEEP OUT OF REACH OF CHILDREN

Children under 2 years of age:
Consult a doctor.

ANALGESIC BALM 
analgesic balm ointment
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:54162-555
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MENTHOL (MENTHOL) MENTHOL1.74 g  in 29 g
METHYL SALICYLATE (SALICYLIC ACID) METHYL SALICYLATE4.06 g  in 29 g
Inactive Ingredients
Ingredient NameStrength
DMDM HYDANTOIN 
WATER 
LANOLIN 
PARAFFIN 
POLYOXYL 40 HYDROGENATED CASTOR OIL 
PETROLATUM 
PHENOXYETHANOL 
CARBOMER COPOLYMER TYPE A 
Packaging
#Item CodePackage Description
1NDC:54162-555-0129 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34803/09/2012
Labeler - Geritrex LLC (112796248)
Establishment
NameAddressID/FEIOperations
Geritrex LLC112796248manufacture(54162-555)

 
Geritrex LLC

Medically reviewed on Sep 19, 2017

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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