Label: ARNICOOL- menthol cream

  • NDC Code(s): 63742-007-00, 63742-007-01
  • Packager: Clinical Resolution Laboratory, Inc.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated December 26, 2023

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  • DRUG FACTS

  • Active Ingredient

    Menthol 4%

    Purpose

    Cooling Pain Relief

  • Uses

    Temporary relief from minor aches and pains of sore muscles and joints associated with arthritis, backache, strains, and sprains.

  • Warnings

    (For external use only)

    Do not use this product if

    • Tamper Evident "Do Not Use...Seal..."label atop the container is broken
    • Pregnant or breastfeeding, ask a health professional before use

    When using this product

    • Avoid contact with the eyes or mucous membranes
    • Do not apply to wounds or damaged skin
    • Do not use with other ointments, creams, sprays or liniments
    • Do not apply to irritated skin or if excessive irritation develops
    • Do not bandage
    • Do not use with heating pad or device

    Stop use and ask a doctor if

    Condition worsens, or if symptoms persist for more than 7 days, or clear up and reccur.

    Keep out of reach of children

    In case of accidental overdose or if ingested, contact a doctor or Poison Control Center immediately.

  • Directions

    • Adults and children 12 years of age older: Apply liberally to the affected area(s) and continue to massage in thoroughly for 1-2 minutes until it has been absorbed. For best results, apply 2-3 times daily for 2 weeks, then as needed.
    • Children under 12 years of age:consult a physician.
  • Other Information

    • Store in room temperature (59~86°F).
  • Inactive Ingredients

    Water, Arnica Montana Flower Extract, Aloe Barbadensis (Aloe Vera) Leaf Extract, Centella Asiatica Extract, Glycerin, Xanthan Gum, Glucosamine, Methylsulfonylmethane (MSM), Helianthus Annuus (Sunflower) Seed Oil, Dromiceius (Emu) Oil, Pyridoxine Hydrochloride (Vitamin B6), Butyrospermum Parkii (Shea) Butter, Dimethicone, Frankincense Serrata Oil, Lavandula Officinalis (Lavender) Oil, Mentha Piperita (Peppermint) Oil, Melaleuca Alternifolia (Tea Tree) Leaf Oil, Cinnamomum Camphora (Camphor) Bark Oil, Tocopherol, Dipotassium Glycyrrhizinate, Glyceryl Stearate / PEG-100 Stearate, Eucalyptus Globulus (Eucalyptus) Leaf Oil, Ethoxydiglycol, Lecithin, Cholesterol, Phenoxyethanol, Disodium EDTA

  • Package Labeling:

    Label3Label4

  • INGREDIENTS AND APPEARANCE
    ARNICOOL 
    menthol cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63742-007
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL40 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    ARNICA MONTANA FLOWER (UNII: OZ0E5Y15PZ)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    CENTELLA ASIATICA (UNII: 7M867G6T1U)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    GLUCOSAMINE (UNII: N08U5BOQ1K)  
    DIMETHYL SULFONE (UNII: 9H4PO4Z4FT)  
    HELIANTHUS ANNUUS FLOWERING TOP (UNII: BKJ0J3D1BP)  
    EMU (UNII: 97P687I7AP)  
    PYRIDOXINE HYDROCHLORIDE (UNII: 68Y4CF58BV)  
    SHEA BUTTER (UNII: K49155WL9Y)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    LAVENDER OIL (UNII: ZBP1YXW0H8)  
    PEPPERMINT OIL (UNII: AV092KU4JH)  
    TEA TREE OIL (UNII: VIF565UC2G)  
    CAMPHOR OIL (UNII: 75IZZ8Y727)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    GLYCYRRHIZINATE DIPOTASSIUM (UNII: CA2Y0FE3FX)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    EUCALYPTUS GUM (UNII: 72T9EZC2VX)  
    DIETHYLENE GLYCOL MONOETHYL ETHER (UNII: A1A1I8X02B)  
    CHOLESTEROL (UNII: 97C5T2UQ7J)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:63742-007-0065 g in 1 JAR; Type 0: Not a Combination Product05/15/2018
    2NDC:63742-007-01130 g in 1 JAR; Type 0: Not a Combination Product05/15/2018
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01705/15/2018
    Labeler - Clinical Resolution Laboratory, Inc. (825047942)
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