Label: ARCTIC HEAT- menthol, methyl salicylate cream

  • NDC Code(s): 76348-414-01
  • Packager: Renu Laboratories, Inc.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not final

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.

Drug Label Information

Updated January 13, 2022

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  • 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

    ARCTIC HEAT tm

  • INGREDIENTS AND APPEARANCE
    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)
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