Label: ARNICA ICE COOLING- camphor menthol gel

  • Category: HUMAN OTC DRUG LABEL

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 May 23, 2016

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  • WARNINGS

    Avoid contact with open wounds, eyes or mucus membrains. If excessive skin irritation develops. Wash with water and discontinue use.
    Consult a doctor if injuries are severe.

  • PURPOSE

    Muscular relief cooling gel

  • ACTIVE INGREDIENT

    ARNICA OIL
    CAMPHOR
    WITCH HAZEL
    MENTHOL CRYSTALS

  • INACTIVE INGREDIENT

    CARBOPOL 990
    WATER
    POLYSORBATE 80
    METHYL HYDROXYBENZOATE
    PROPYL HYDROXYBENZOATE
    TRIETHANOLAMINE 85%

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children, animals and uniformed persons.
    Although this remedy has been extensively tested under a wide variety of conditions, failure thereof may ensue as a result of a wide range of reasons. If this is suspected, seek advice and notify the registration holder.
    This medicine has not been evaluated by the MCC.
    This medicine is not intended to diagnose, treat, cure or prevent any disease.

  • DOSAGE & ADMINISTRATION

    Use only as directed

  • INDICATIONS & USAGE

    indications and usage

  • PRINCIPAL DISPLAY PANEL

    LABEL

  • INGREDIENTS AND APPEARANCE
    ARNICA ICE COOLING 
    camphor menthol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70674-001
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CAMPHOR (NATURAL) (UNII: N20HL7Q941) (CAMPHOR (NATURAL) - UNII:N20HL7Q941) CAMPHOR (NATURAL)6.0 mg  in 100 mg
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL1 mg  in 100 mg
    Inactive Ingredients
    Ingredient NameStrength
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    CARBOMER COPOLYMER TYPE A (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 71DD5V995L)  
    WATER (UNII: 059QF0KO0R)  
    WITCH HAZEL (UNII: 101I4J0U34)  
    ARNICA MONTANA FLOWER WATER (UNII: U7L2JP51PR)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70674-001-01475 mg in 1 JAR; Type 0: Not a Combination Product05/24/2016
    2NDC:70674-001-02100 mg in 1 PACKAGE; Type 0: Not a Combination Product05/24/2016
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34805/23/2016
    Labeler - Kyron Laboratories (pty) Ltd (568517155)
    Establishment
    NameAddressID/FEIBusiness Operations
    Kyron Laboratories (pty) Ltd568517155manufacture(70674-001)
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