Label: ASSURED MUSCLE RUB- menthol gel
- NDC Code(s): 33992-1136-1
- Packager: Greenbrier International, Inc.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not final
NOTE: Most over the counter (OTC) are not reviewed and approved by the 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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- ACTIVE INGREDIENT
- INDICATIONS & USAGE
Uses ▪ Provides soothing relief of minor arthritis pain, aching muscles, joints and backache.Close
For external use only. Use only as directed.Close
▪ 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 REACH OF CHILDREN
Keep out of the reach of children to avoid accidental poisoning. If swallowed, get medical help or contact a Poison Control Center right awayClose
- DOSAGE & ADMINISTRATION
▪ 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 doctorClose
- SPL UNCLASSIFIED SECTION
▪Store at controlled room temperature 15 to 30C (59 to 86F) ▪ Lot No. Exp. Date: see box or see crimp of tube.Close
- INACTIVE INGREDIENT
Inactive Ingredients Camphor, Carbomer, DMDM Hydantoin, Isoceteth, Isopropyl Alcohol,PEG-40 Hydrogenated Castor Oil, Sodium Hydroxide and WaterClose
- PRINCIPAL DISPLAY PANEL
- INGREDIENTS AND APPEARANCE
ASSURED MUSCLE RUB
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:33992-1136 Route of Administration TOPICAL DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL 2.5 g in 100 g Inactive Ingredients Ingredient Name Strength CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET) DMDM HYDANTOIN (UNII: BYR0546TOW) ISOPROPYL ALCOHOL (UNII: ND2M416302) POLYOXYL 40 HYDROGENATED CASTOR OIL (UNII: 7YC686GQ8F) SODIUM HYDROXIDE (UNII: 55X04QC32I) WATER (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:33992-1136-1 42.5 g in 1 TUBE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part348 05/15/2012 Labeler - Greenbrier International, Inc. (610322518)