OTC Medication Information: Analgesic Balm

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.

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
(click image for full-size original)
ANALGESIC BALM
menthol and methyl salicylate ointment
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:68788-9828(NDC:54162-555)
Route of Administration ENTERAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
MENTHOL (MENTHOL) MENTHOL 6 g in 100 g
METHYL SALICYLATE (METHYL SALICYLATE) METHYL SALICYLATE 14 g in 100 g
Inactive Ingredients
Ingredient Name Strength
DMDM HYDANTOIN
WATER
LANOLIN
PARAFFIN
POLYOXYL 40 HYDROGENATED CASTOR OIL
PETROLATUM
PHENOXYETHANOL
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:68788-9828-2 29 g in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part348 04/05/2012
Labeler — Preferred Pharmaceuticals, Inc (791119022)
Establishment
Name Address ID/FEI Operations
Preferred Pharmaceuticals, Inc 791119022 RELABEL (68788-9828)

Revised: 04/2012 Preferred Pharmaceuticals, Inc

Our database comes directly from the FDA’s central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA’s repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

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Our database comes directly from the FDA's central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA's repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

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