Search by Drug Name or NDC

NDC 42452-0379-00 Revalife Pain Relief Cream .05; .075 kg/kg; kg/kg Details

Revalife Pain Relief Cream .05; .075 kg/kg; kg/kg

Revalife Pain Relief Cream is a TOPICAL CREAM in the HUMAN OTC DRUG category. It is labeled and distributed by International Nutraceutical Company of America, LLC. The primary component is MENTHOL; METHYL SALICYLATE.

Product Information

NDC	42452-0379
Product ID	42452-379_291a7722-a53d-4827-b9f6-897226369d92
Associated GPIs
GCN Sequence Number	n/a
GCN Sequence Number Description	n/a
HIC3	n/a
HIC3 Description	n/a
GCN	n/a
HICL Sequence Number	n/a
HICL Sequence Number Description	n/a
Brand/Generic	n/a
Proprietary Name	Revalife Pain Relief Cream
Proprietary Name Suffix	n/a
Non-Proprietary Name	Menthol, Methyl Salicylate
Product Type	HUMAN OTC DRUG
Dosage Form	CREAM
Route	TOPICAL
Active Ingredient Strength	.05; .075
Active Ingredient Units	kg/kg; kg/kg
Substance Name	MENTHOL; METHYL SALICYLATE
Labeler Name	International Nutraceutical Company of America, LLC
Pharmaceutical Class	n/a
DEA Schedule	n/a
Marketing Category	OTC MONOGRAPH NOT FINAL
Application Number	part348
Listing Certified Through	2024-12-31

Package

Package Images

NDC 42452-0379-00 (42452037900)

Pricing Information	N/A
NDC Package Code	42452-379-00
Billing NDC	42452037900
Package	.00288 kg in 1 PACKET (42452-379-00)
Marketing Start Date	2020-03-31
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL 2b7e9ef7-f777-4b50-bf30-20e880b230a1 Details

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!

SPL UNCLASSIFIED SECTION

Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center immediately.

SPL UNCLASSIFIED SECTION

Do not use:

• on wounds or damaged skin

• with a heating pad

• on a child under 12 years of age with arthritis-like conditions

SPL UNCLASSIFIED SECTION

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.

SPL UNCLASSIFIED SECTION

When using this product:

• avoid contact with eyes or mucous membranes

• do not bandage tightly

SPL UNCLASSIFIED SECTION

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

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
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

Ingredient Name	Strength
Inactive Ingredients
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)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:42452-379-01	0.114 kg in 1 TUBE; Type 0: Not a Combination Product	03/31/2020
2	NDC:42452-379-00	0.00288 kg in 1 PACKET; Type 0: Not a Combination Product	03/31/2020

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

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

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

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

Revised: 2/2022

Document Id: 291a7722-a53d-4827-b9f6-897226369d92

Set id: 2b7e9ef7-f777-4b50-bf30-20e880b230a1

Version: 3

Effective Time: 20220214

Search by Drug Name or NDC

NDC 42452-0379-00 Revalife Pain Relief Cream .05; .075 kg/kg; kg/kg Details

Revalife Pain Relief Cream .05; .075 kg/kg; kg/kg

Product Information

Package

Package Images

NDC 42452-0379-00 (42452037900)

Contents

Standard Product Labeling (SPL)/Prescribing Information SPL 2b7e9ef7-f777-4b50-bf30-20e880b230a1 Details

DRUG FACTS

Uses:

Warnings:

SPL UNCLASSIFIED SECTION

SPL UNCLASSIFIED SECTION

SPL UNCLASSIFIED SECTION

SPL UNCLASSIFIED SECTION

SPL UNCLASSIFIED SECTION

Directions:

Inactive Ingredients:

Other Information:

Allergy Alert:

For Questions

PRINCIPAL DISPLAY PANEL

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

Questions About Combining Hydroxyzine And Buspirone

Can You Take A Z-Pak If You Have A Penicillin Allergy?