ARCTIC HEAT- menthol, methyl salicylate cream

ARCTIC HEAT by

Drug Labeling and Warnings

ARCTIC HEAT by is a Otc medication manufactured, distributed, or labeled by Renu Laboratories, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENTS

Menthol 2%

Methyl Salicylate 10%

PURPOSE

Topical Analgesic

Topical Analgesic

USES

Temporarily relieves minor aches and pains of muscle and joints due to: arthritis, simple backache, sprains, strains and bruises

Warnings

For external use only

When using this product

• Do not apply to wounds or damaged skin
• Do not bandage tightly
• Do not use in or near eyes; if product gets into eyes rinse thoroughly with water
• Do not use with an electric heating pad

Stop use and ask doctor if

• Conditions worsen
• Symptoms last for more than 7 days or clear up and occur again within a few days
• A rash or irritation develops

If pregnant or breast-feeding,

Ask a health professional before use.

Keep out of reach of children.

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

Inactive Ingredients

Allantoin, Benzoic Acid, C13-14 Isoparaffin, Capsicum Frutescens Fruit Extract, Cetearyl Alcohol, Cetearyl Glucoside, Dehydroacetic Acid, Deionized Water, Emu Oil, Eucalyptus Globulus Leaf Oil, Glyceryl Stearate, Laureth-7, Mentha Piperita (Peppermint) Oil, Niacinamide, PEG-100 Stearate, Phenoxyethanol, Stearic Acid.

ARCTIC HEAT

Dual Active Botanical Warming Formula with Emu Oil

QUESTIONS

Manufactured by:

Renu Labs Inc.

Ivyland, PA 18974

www.RenuLabs.com

DOSAGE & ADMINISTRATION

Directions

Adults and children 12 years of age and

older: Apply directly to affected area no more than 3 to 4 times daily.

ARCTIC HEAT TUBE

INGREDIENTS AND APPEARANCE

ARCTIC HEAT 
menthol, methyl salicylate cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 76348-414
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	2.24 g  in 112 g
METHYL SALICYLATE (UNII: LAV5U5022Y) (SALICYLIC ACID - UNII:O414PZ4LPZ)	METHYL SALICYLATE	11.2 g  in 112 g

Inactive Ingredients
Ingredient Name	Strength
PEG-100 STEARATE (UNII: YD01N1999R)
TABASCO PEPPER (UNII: J1M3NA843L)
ALLANTOIN (UNII: 344S277G0Z)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
BENZOIC ACID (UNII: 8SKN0B0MIM)
DEHYDROACETIC ACID (UNII: 2KAG279R6R)
LAURETH-7 (UNII: Z95S6G8201)
STEARIC ACID (UNII: 4ELV7Z65AP)
SODIUM ACRYLOYLDIMETHYLTAURATE-ACRYLAMIDE COPOLYMER (1:1; 90000-150000 MPA.S) (UNII: 5F4963KLHS)
EMU OIL (UNII: 344821WD61)
EUCALYPTUS OIL (UNII: 2R04ONI662)
NIACINAMIDE (UNII: 25X51I8RD4)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
CETEARYL GLUCOSIDE (UNII: 09FUA47KNA)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
WATER (UNII: 059QF0KO0R)
PEPPERMINT OIL (UNII: AV092KU4JH)
C13-14 ISOPARAFFIN (UNII: E4F12ROE70)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 76348-414-01	112 g in 1 TUBE; Type 0: Not a Combination Product	09/17/2015

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	09/17/2015

Labeler - Renu Laboratories, Inc. (945739449)

Establishment
Name	Address	ID/FEI	Business Operations
Renu Laboratories, Inc.		945739449	manufacture(76348-414)