Label: HERBAL HEALERS MENTHOL WARMING ROLL ON- menthol liquid

  • NDC Code(s): 76348-581-01, 76348-581-03
  • 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 14, 2022

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  • ACTIVE INGREDIENT

    Menthol 5%

  • PURPOSE

    Topical Analgesic

  • INDICATIONS & USAGE

    Uses for temporary relief of minor aches and pains of muscles and joints associated with deep muscle therapy treatments.

  • WARNINGS

    For external use only

  • WHEN USING

    Do not bandage tightly

    • avoid contact with eyes
    • do not apply to wounds or damaged skin
    • do not use with heating pads or other heating devices.

  • STOP USE

    Stop use and ask a doctor if

    Condition worsens of if symptoms persist for more then 7 days or clear p and occur again within a few days

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children

    If swallowed, get medical help or contact a Poison Control Center right away.

  • DOSAGE & ADMINISTRATION

    Directions

    adults and children 12 years of age and older, apply to affected area no more than 10 times a day or as directed by your doctor

    children under 12 years of age, do not use. Consult a healthcare professional.

  • INACTIVE INGREDIENT

    Arnica Montana (Arnica) Flower Extract, Cannabis Sativa (Hemp) Seed Oil and Hemp Derived Cannabidiol (CBD) Extract, Hemp Derived Cannabigerol (CBG) Extract with proprietary terpene blend (Alpha Pinene, Beta Caryophyllene, Myrcene, Limonene, Linalool, Terpinolene), Capsicum frutescens extract, Deionized Water, Citrus Paradisi (Grapefruit) Extract, Hippophae Rhamnoides (Sea Berry) Fruit and Seed Oil, Hydroxyethyl Celluose, Isopropyl Alcohol, Lobelia Flower Extract, Magnesium Chloride, Magnesium Sulfate, Mentha piperita (Peppermint) Leaf Oil, Polysorbate 80, Potassium Sorbate, Sodium Benzoate, Virginiana Hamamelis (Witch Hazel).

  • QUESTIONS

    Questions ? www.HerbalHealersCBD.com

  • STATEMENT OF IDENTITY

    HERBAL HEALERS

    Menthol WARMING

    Pain Relief

    Roll-On

  • PRINCIPAL DISPLAY PANEL

    HH LabelWARMING PAIN RELIEF ROLL-ON LABEL AND BOX

    HH BoxBOX ART

  • INGREDIENTS AND APPEARANCE
    HERBAL HEALERS MENTHOL WARMING ROLL ON 
    menthol liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:76348-581
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL4.2 g  in 84 g
    Inactive Ingredients
    Ingredient NameStrength
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    WATER (UNII: 059QF0KO0R)  
    WITCH HAZEL (UNII: 101I4J0U34)  
    LOBELIA INFLATA (UNII: 9PP1T3TC5U)  
    MAGNESIUM CHLORIDE (UNII: 02F3473H9O)  
    ARNICA MONTANA FLOWER (UNII: OZ0E5Y15PZ)  
    HIPPOPHAE RHAMNOIDES FRUIT OIL (UNII: TA4JCF9S1J)  
    ISOPROPYL ALCOHOL (UNII: ND2M416302)  
    CANNABIGEROL (UNII: J1K406072N)  
    LIMONENE, (+)- (UNII: GFD7C86Q1W)  
    POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
    .ALPHA.-PINENE (UNII: JPF3YI7O34)  
    LINALOOL, (+)- (UNII: F4VNO44C09)  
    HIPPOPHAE RHAMNOIDES SEED OIL (UNII: T53SBG6741)  
    CANNABIDIOL (UNII: 19GBJ60SN5)  
    CANNABIS SATIVA SEED OIL (UNII: 69VJ1LPN1S)  
    MAGNESIUM SULFATE, UNSPECIFIED (UNII: DE08037SAB)  
    PEPPERMINT OIL (UNII: AV092KU4JH)  
    METHYLCELLULOSE (4000 CPS) (UNII: MRJ667KA5E)  
    TERPINOLENE (UNII: N9830X5KSL)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    CARYOPHYLLENE (UNII: BHW853AU9H)  
    MYRCENE (UNII: 3M39CZS25B)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:76348-581-011 in 1 BOX10/12/2020
    1NDC:76348-581-0384 g in 1 APPLICATOR; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34810/12/2020
    Labeler - Renu Laboratories, Inc. (945739449)
    Establishment
    NameAddressID/FEIBusiness Operations
    Renu Laboratories, Inc.945739449manufacture(76348-581)
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