Your browser does not support JavaScript! ASSURED MUSCLE RUB (MENTHOL) GEL [GREENBRIER INTERNATIONAL, INC.]
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ASSURED MUSCLE RUB (menthol) gel
[Greenbrier International, Inc.]


Category DEA Schedule Marketing Status
HUMAN OTC DRUG LABEL OTC monograph not final
NOTE: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 Label Sections

Active Ingredients
Menthol 2.5%

Purpose
Topical Analgesic

Uses ▪ Provides soothing relief of minor arthritis pain, aching muscles, joints and backache.

Warnings

For external use only. Use only as directed.
▪ Avoid contact with eyes or mucous membranes. ▪ Discontinue use if excessive irritation of the skin develops. ▪ Do not bandage tightly, apply to wounds, broken or irritated skin, or use with a heating pad. ▪ If condition worsens, or if symptoms persist for more than 10 days or clear-up and occur again within a few days, if skin redness or irritation develops, discontinue use of this product and consult a doctor.

Keep out of the reach of children to avoid accidental poisoning. If swallowed, get medical help or contact a Poison Control Center right away

Directions

▪ Adults and children12 years of age and older: apply to affected area not more than 3-4 times daily and gently massage until gel disappears. ▪ Children under 12 years of age: donot use, consult a doctor

Other Information

▪Store at controlled room temperature 15 to 30C (59 to 86F) ▪ Lot No. Exp. Date: see box or see crimp of tube.

Inactive Ingredients Camphor, Carbomer, DMDM Hydantoin, Isoceteth, Isopropyl Alcohol,PEG-40 Hydrogenated Castor Oil, Sodium Hydroxide and Water

Package Label
image of package label

ASSURED  MUSCLE RUB
menthol gel
Product Information
Product TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:33992-1136
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MENTHOL (MENTHOL) MENTHOL2.5 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
CAMPHOR (SYNTHETIC) 
DMDM HYDANTOIN 
ISOPROPYL ALCOHOL 
POLYOXYL 40 HYDROGENATED CASTOR OIL 
SODIUM HYDROXIDE 
WATER 
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:33992-1136-142.5 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34805/15/2012
Labeler - Greenbrier International, Inc. (610322518)

Revised: 4/2012
 
Greenbrier International, Inc.

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