ANALGESIC BALM- menthol and methyl salicylate ointment 
Preferred Pharmaceuticals, Inc

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

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

Deionized Water, DMDM Hydantoin, Lanolin Anhydrous, Paraffin Wax, Peg-40 Hydrogenated Castor Oil, Petrolatum Super White, Phenoxy Ethanol.

STORAGE


At room temperature 15º-30º C (59º-86º F). Close cap tightly after use.

OTC - KEEP OUT OF REACH OF CHILDREN

Children under 2 years of age: Consult a doctor.

HOW SUPPLIED

Analgesic balm is available in a 29gm bottle – NDC 68788-9828-2

Relabeled By Preferred Pharmaceuticals, Inc

PRINCIPAL DISPLAY PANEL

Analgesic Balm External Analgesic label
ANALGESIC BALM 
menthol and methyl salicylate ointment
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68788-9828(NDC:54162-555)
Route of AdministrationENTERALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MENTHOL (MENTHOL) MENTHOL6 g  in 100 g
METHYL SALICYLATE (METHYL SALICYLATE) METHYL SALICYLATE14 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
DMDM HYDANTOIN 
WATER 
LANOLIN 
PARAFFIN 
POLYOXYL 40 HYDROGENATED CASTOR OIL 
PETROLATUM 
PHENOXYETHANOL 
Packaging
#Item CodePackage Description
1NDC:68788-9828-229 g in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34804/05/2012
Labeler - Preferred Pharmaceuticals, Inc (791119022)
Establishment
NameAddressID/FEIBusiness Operations
Preferred Pharmaceuticals, Inc791119022RELABEL(68788-9828)

Revised: 04/2012
Document Id: b117c4f0-2579-46a6-9433-c5b5dfcf2b84
Set id: b117c4f0-2579-46a6-9433-c5b5dfcf2b84
Version: 1
Effective Time: 20120405
 
Preferred Pharmaceuticals, Inc