REVALIFE- topical menthol ointment

Revalife by

Drug Labeling and Warnings

Revalife by is a Otc medication manufactured, distributed, or labeled by International Nutraceutical Company of America (INCA), LLC, International Nutraceutical Company of Americe (INCA), LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active Ingredient : Menthol 3%

PURPOSE

Purpose-Topical Analgesic

INDICATIONS & USAGE

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

DOSAGE & ADMINISTRATION

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

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

WARNINGS

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 INGREDIENT

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

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

REVALIFE 
topical menthol ointment

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 42452-378
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	937.5 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 42452-378-48	1 in 1 CARTON	01/26/2012
1	NDC: 42452-378-49	85 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	01/26/2012

Labeler - International Nutraceutical Company of America (INCA), LLC (941002250)

Registrant - International Nutraceutical Company of Americe (INCA), LLC (941002250)