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ARCTIC HEAT

Dosage form: cream
Ingredients: MENTHOL 2.24g in 112g, METHYL SALICYLATE 11.2g in 112g
Labeler: Renu Laboratories, Inc.
NDC Code: 76348-414

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.

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

  • 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

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 
menthol, methyl salicylate cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:76348-414
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MENTHOL (MENTHOL) MENTHOL2.24 g  in 112 g
METHYL SALICYLATE (SALICYLIC ACID) METHYL SALICYLATE11.2 g  in 112 g
Inactive Ingredients
Ingredient NameStrength
PEG-100 STEARATE 
TABASCO PEPPER 
ALLANTOIN 
PHENOXYETHANOL 
BENZOIC ACID 
LAURETH-7 
STEARIC ACID 
SODIUM ACRYLOYLDIMETHYLTAURATE-ACRYLAMIDE COPOLYMER (1:1; 90000-150000 MPA.S) 
EMU OIL 
EUCALYPTUS OIL 
NIACINAMIDE 
CETOSTEARYL ALCOHOL 
CETEARYL GLUCOSIDE 
GLYCERYL MONOSTEARATE 
WATER 
PEPPERMINT OIL 
C13-14 ISOPARAFFIN 
DEHYDROACETIC ACID 
Packaging
#Item CodePackage Description
1NDC:76348-414-01112 g in 1 TUBE
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/FEIOperations
Renu Laboratories, Inc.945739449manufacture(76348-414)

Revised: 10/2016
 
Renu Laboratories, Inc.

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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