REVALIFE PAIN RELIEF CREAM- menthol, methyl salicylate cream

Revalife Pain Relief Cream by

Drug Labeling and Warnings

Revalife Pain Relief Cream by is a Otc medication manufactured, distributed, or labeled by International Nutraceutical Company of America, LLC, Cosco International, Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

DRUG FACTS

Menthol - 5% (External Analgesic)
Methyl Salicylate (NSAID) – 7.5% (External Analgesic)

Uses:

For temporary relief of minor aches and pains of muscles and joints associated with backache, muscle ache, strains, sprains, bruises, cramps, arthritis, and inflammation

Warnings:

External Use Only!

KEEP OUT OF REACH OF CHILDREN

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

DO NOT USE

Do not use:
on wounds or damaged skin
with a heating pad
on a child under 12 years of age with arthritis-like conditions

ASK DOCTOR

Ask a doctor before use if you have redness over the affected area.

If pregnant or breast-feeding, or if you have sensitive skin, ask your doctor before use

Avoid contact with eyes. If contact occurs, flush thoroughly with water.

WHEN USING

When using this product:
avoid contact with eyes or mucous membranes
do not bandage tightly

INDICATIONS & USAGE

Stop use and ask a doctor if: condition worsens or symptoms persist for more than 7 days, symptoms clear up and occur again within a few days, excessive skin irritation occurs

Directions:

Use only as directed. Apply generously and massage to affected area as needed. Do not use more than 3 to 4 times per day.
Children under 12 years of age: ask a doctor before use.

Inactive Ingredients:

Alpha-Tocopherol Acetate (Vitamin E), Aminomethylpropanol, Arnica Montana Flower, Carbomer, Cetostearyl Alcohol, Coconut Oil, Dimethyl Sulfone, Dimethyl Sulfoxide, Ethylhexylglycerin, Glucosamine HCL, Glyceryl Monostearate, Hemp Oil, Magnesium Hydroxide, N-Acetyl Glucosamine, Phenoxyethanol, Polysorbate 80, Water

Other Information:

Store at room temperature 68°F to 77°F (20° to 25°C)
Do not expose to excessive heat

Allergy Alert:

Do not use if you are allergic to salicylates (including aspirin) without consulting a physician.

For Questions

International Neutraceutical Company of America, LLC

1551 Dunwoody Village Parkway

P.O. Box 888882 

Dunwoody, GA 30356 USA

+1 (404) 402-9354

www.revalife.com

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

REVALIFE PAIN RELIEF CREAM 
menthol, methyl salicylate cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 42452-379
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	0.05 kg  in 1 kg
METHYL SALICYLATE (UNII: LAV5U5022Y) (SALICYLIC ACID - UNII:O414PZ4LPZ)	METHYL SALICYLATE	0.075 kg  in 1 kg

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
CARBOMER HOMOPOLYMER TYPE C (UNII: 4Q93RCW27E)
DIMETHYL SULFONE (UNII: 9H4PO4Z4FT)
DIMETHYL SULFOXIDE (UNII: YOW8V9698H)
N-ACETYLGLUCOSAMINE (UNII: V956696549)
GLUCOSAMINE HYDROCHLORIDE (UNII: 750W5330FY)
GLYCERYL STEARATE SE (UNII: FCZ5MH785I)
Polysorbate 80 (UNII: 6OZP39ZG8H)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
ARNICA MONTANA (UNII: O80TY208ZW)
CANNABIS SATIVA SEED OIL (UNII: 69VJ1LPN1S)
COCONUT OIL (UNII: Q9L0O73W7L)
.ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
MAGNESIUM HYDROXIDE (UNII: NBZ3QY004S)
AMINOMETHYLPROPANOL (UNII: LU49E6626Q)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 42452-379-01	0.114 kg in 1 TUBE; Type 0: Not a Combination Product	03/31/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	03/31/2020

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

Registrant - International Nutraceutical Company of America, LLC (941002250)

Establishment
Name	Address	ID/FEI	Business Operations
Cosco International, Inc		016433141	manufacture(42452-379) , relabel(42452-379) , pack(42452-379)