Revalife

Dosage form: ointment
Ingredients: MENTHOL 937.5mg in 1g
Labeler: International Nutraceutical Company of America (INCA), LLC
NDC Code: 42452-378

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

Active Ingredient : Menthol 3%

Purpose-Topical Analgesic

Uses-Temporarily relieves minor pain of joints and muscles associated with arthritis, bursitis, tendonitis, strains

Directions: Apply to clean, dry skin over painful joint or muscle gently massaging until cream disappears.  For optimum results use daily for 30 days and continue to use daily thereafter.  Repeat as neccessary.  Close cap tightly after use.

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

For external use only.  Do not bandage tightly or use with a heating pad.  Avoid contact with mouth, eyes, and mucous membranes. Do not apply to wounds, damaged, broken, or irritated skin.

Stop use and ask a doctor if: Symptoms persists over 7 day or clear up and occur again within a few days.  Redness is present or irritation develops. Using on a child 12 years of age or under.

Inactive Ingredients: EDTA, Ethanol,  Isopropyl palmitate, Methyl Paraben, Monosodium Phosphate, N-Acetyl Glucosamine, Poloxamer 407, Propyl Paraben,  Soy Lecithin, Todopherol Acetate (Vitamin E), Water

MM1





If pregnant or breast feeding, ask a health professional before use

REVALIFE 
topical menthol ointment
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:42452-378
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MENTHOL (MENTHOL) MENTHOL937.5 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
ISOPROPYL PALMITATE 
ALPHA-TOCOPHEROL 
LECITHIN, SOYBEAN 
ALCOHOL 
METHYLPARABEN 
PROPYLPARABEN 
N-ACETYLGLUCOSAMINE 
Packaging
#Item CodePackage Description
1NDC:42452-378-4985 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34801/26/2012
Labeler - International Nutraceutical Company of America (INCA), LLC (941002250)
Registrant - International Nutraceutical Company of Americe (INCA), LLC (941002250)

Revised: 01/2012
 
International Nutraceutical Company of America (INCA), LLC

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

Hide
(web4)