REVALIFE- topical menthol ointment 
International Nutraceutical Company of America (INCA), LLC

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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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

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

Revalife 3 ounce tube carton

REVALIFE 
topical menthol ointment
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:42452-378
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL937.5 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
ISOPROPYL PALMITATE (UNII: 8CRQ2TH63M)  
ALPHA-TOCOPHEROL (UNII: H4N855PNZ1)  
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)  
ALCOHOL (UNII: 3K9958V90M)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
N-ACETYLGLUCOSAMINE (UNII: V956696549)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:42452-378-481 in 1 CARTON01/26/2012
1NDC:42452-378-4985 g in 1 TUBE; Type 0: Not a Combination Product
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: 12/2017
Document Id: 131dfafb-a223-40a6-ac98-a7cbe8522c9c
Set id: 9e4585bc-273f-4e7b-b95e-ff61cde89cd9
Version: 2
Effective Time: 20171206
 
International Nutraceutical Company of America (INCA), LLC