BANALG- methyl salicylate lotion

Banalg by

Drug Labeling and Warnings

Banalg by is a Otc medication manufactured, distributed, or labeled by Rebel Distributors Corp. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient

Methyl Salicylate 14.0%

Menthol 3.0%

PURPOSE

Keep Out of Reach of Children

Uses

For the temporary relief of minor ach3es and pains of muscles and joints associated with arthritis and rheumatism. Also good for simple backache, strains and sprains.

Warnings

Use only as directed. If pain persists more than 10 days, or redness is present, or in conditions affecting children under 12 years of age, consult your physician immediately. Discontinue use if excessive irritation of the skin develops. Avoid getting into the eyes or on mucous membranes.

For external use only. Use only as directed. Do not apply to wounds, broken or irritated skin. Do not use with a heating pad. Do not bandage tightly.

If swallowed, induce vomiting and contact a physician or poison control center immediately.

Directions

Apply fast vanishing lotion with gentle massage to affected area not more than 3 to 4 times daily.

INACTIVE INGREDIENT

Package/Label Principal Display Panel

INGREDIENTS AND APPEARANCE

BANALG 
methyl salicylate lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 21695-440(NDC: 0456-0525)
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
METHYL SALICYLATE (UNII: LAV5U5022Y) (METHYL SALICYLATE - UNII:LAV5U5022Y)	METHYL SALICYLATE	140 mg  in 1 g
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	30 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
1,3-DIMETHYLBUTYL SALICYLATE (UNII: 47OL39K42M)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 21695-440-02	60 g in 1 BOTTLE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	01/01/2007

Labeler - Rebel Distributors Corp (118802834)

Establishment
Name	Address	ID/FEI	Business Operations
Rebel Distributors Corp		118802834	RELABEL, REPACK