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Name:Banalg
Manufacturer:Rebel Distributors Corp
Category:Over-the-counter (OTC) Marketed Drugs


Banalg Drug Facts

BANALG - methyl salicylate and menthol lotion 
Rebel Distributors Corp

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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Banalg Drug Facts

Active ingredient

Methyl Salicylate 14.0%

Menthol 3.0%

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.

Package/Label Principal Display Panel

Banalg Hospital Strength


BANALG 
methyl salicylate lotion
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:21695-440(NDC:0456-0525)
Route of Administration TOPICAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
METHYL SALICYLATE (METHYL SALICYLATE) METHYL SALICYLATE 140 mg  in 1 g
MENTHOL (MENTHOL) MENTHOL 30 mg  in 1 g
Inactive Ingredients
Ingredient Name Strength
1,3-DIMETHYLBUTYL SALICYLATE  
WATER  
Product Characteristics
Color      Score     
Shape Size
Flavor Imprint Code
Contains     
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:21695-440-02 60 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 01/01/2007

Labeler - Rebel Distributors Corp (118802834)
Establishment
Name Address ID/FEI Operations
Rebel Distributors Corp 118802834 RELABEL, REPACK

Revised: 02/2011 Rebel Distributors Corp



Source: http://dailymed.nlm.nih.gov
Reproduced with permission of U.S. National Library of Medicine


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