ARCTIC HEAT- menthol, methyl salicylate cream 
Renu Laboratories, Inc.

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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ARCTIC HEAT

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


Stop use and ask doctor if

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

Manufactured by:

Renu Labs Inc.

Ivyland, PA 18974

www.RenuLabs.com

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

ARCTIC HEAT tm

ARCTIC HEAT 
menthol, methyl salicylate cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:76348-414
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL2.24 g  in 112 g
METHYL SALICYLATE (UNII: LAV5U5022Y) (SALICYLIC ACID - UNII:O414PZ4LPZ) METHYL SALICYLATE11.2 g  in 112 g
Inactive Ingredients
Ingredient NameStrength
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)  
DEHYDROACETIC ACID (UNII: 2KAG279R6R)  
PEG-100 STEARATE (UNII: YD01N1999R)  
TABASCO PEPPER (UNII: J1M3NA843L)  
ALLANTOIN (UNII: 344S277G0Z)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
BENZOIC ACID (UNII: 8SKN0B0MIM)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:76348-414-01112 g in 1 TUBE; Type 0: Not a Combination Product09/17/2015
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34809/17/2015
Labeler - Renu Laboratories, Inc. (945739449)
Establishment
NameAddressID/FEIBusiness Operations
Renu Laboratories, Inc.945739449manufacture(76348-414)

Revised: 1/2022
Document Id: d5794985-97b6-3b24-e053-2a95a90a5a92
Set id: 402df5c1-b8cb-17a2-e054-00144ff8d46c
Version: 7
Effective Time: 20220113
 
Renu Laboratories, Inc.