Label: EMU THERAPY COOL MENTHOL THERAPY PAIN RELIEF CREAM- menthol cream

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated November 6, 2023

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  • Active Ingredient:

    Menthol, USP (2.75%)

    Purpose:

    Topical Analgesic

  • Uses:

    Temporary relief of minor aches and pains associated with arthritis, simple backache, strains, sprains, and bruises.

  • Warnings:

    • For external use only.

    Do not use

    on wounded, damaged or irritated skin.

    When using this product

    avoid contact with eyes or mucous membranes, do not bandage tightly.

    Stop use and ask a doctor 

    • if you experience a rash and/or a reaction, condition worsens, or if symptoms persist for more than 10 days or clear up and occur again within a few days. 

    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.

  • Directions:

    • For adults and children 2 years of age and older: apply to affected area not more than 3 or 4 times a day. Consult a doctor before using for children under 2 years of age.
  • Inactive Ingredients:

    Aloe Barbadensis leaf (Aloe Vera Gel) Juice, Anthemis Nobilis (Roman Chamomile) Oil, Aqua (Deionized water), Arnica Montana Flower Extract, Ascorbyl Palmitate (Vitamin C), Calendula Officinalis Extract, Capsaicin, Carbomer, Centaurea Cyanus (Cornflower) Extract, Chamomilla Matricaria (Chamomile) Extract, Coriandrum Sativum (Coriander) Oil, Emu Oil, Ethylhexylglycerin, FD&C Blue #1; FD&C Yellow #5, Glycerin, Hamamelis Virginiana (Witch Hazel), Helianthus Annuus (Sunflower) Oil, Hypericum Perforatum (St. John's Wort), Lamium Album (White Nettle) Extract, Methylsulfonylmethane (MSM), Parfum (Fragrance), Phenoxyethanol, Salix Alba (Willow) Bark Extract, SD-Alohol 40B, Sodium Lauryl Sulfate, Sorbitol, Tanacetum Parthenium (Feverfew) Extract, Tilla Cordata (Linden) Bark Extract, Triethanolamine.

  • Questions or Comments?

    1-800-222-0554 or www.coolmentholTheropyPainCream.com

  • Package Labeling:

    Label

  • INGREDIENTS AND APPEARANCE
    EMU THERAPY COOL MENTHOL THERAPY PAIN RELIEF CREAM 
    menthol cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:83591-416
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL27.5 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    WATER (UNII: 059QF0KO0R)  
    ARNICA MONTANA FLOWER (UNII: OZ0E5Y15PZ)  
    ASCORBYL PALMITATE (UNII: QN83US2B0N)  
    CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD)  
    CAPSAICIN (UNII: S07O44R1ZM)  
    CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)  
    CHAMOMILE (UNII: FGL3685T2X)  
    CORIANDER (UNII: 1OV56052IK)  
    EMU OIL (UNII: 344821WD61)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK (UNII: T7S323PKJS)  
    HYPERICUM PERFORATUM WHOLE (UNII: XK4IUX8MNB)  
    LAMIUM ALBUM WHOLE (UNII: 046Y1357I6)  
    DIMETHYL SULFONE (UNII: 9H4PO4Z4FT)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    SALIX ALBA BARK (UNII: 205MXS71H7)  
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    SORBITOL (UNII: 506T60A25R)  
    FEVERFEW (UNII: Z64FK7P217)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:83591-416-00237 mL in 1 JAR; Type 0: Not a Combination Product08/08/2023
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01708/08/2023
    Labeler - ACA MANAGEMENT LLC (119034214)
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