Label: HEALTHWISE MENTHOL 4% ROLL-ON- menthol liquid

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

Drug Label Information

Updated May 16, 2024

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  • SPL UNCLASSIFIED SECTION

    HealthWise Menthol 4% Roll-On

  • Active ingredient

    Menthol 4%

  • Purpose

    Topical analgesic

  • Uses

    Uses Temporarily relieves minor pain associated with: ■ arthritis ■ simple backache ■ muscle

    strains ■ sprains ■ bruises ■ cramps

  • Warnings

    For external use only

    When using this product

    When using this product

    ■ use only as directed. Read and follow all directions and warnings on this carton

    ■ rare cases of serious burns have been reported with products of this type

    ■ do not bandage tightly or apply local heat (such as heating pads) or a medicated patch to the area of use
    ■ avoid contact with eyes and mucous membranes

    ■ do not apply to wounds or damaged, broken or irritated skin

    ■ a transient burning sensation may occur upon application but generally disappears in several days

    ■ if severe burning sensation occurs, discontinue use immediately
    ■ do not expose the area treated with the product to heat or direct sunlight
    ■ avoid applying into skin folds

    Stop use and ask a doctor if

    • condition worsens
    • redness is present
    • irritation develops
    • symptoms persist for more than 7 days or clear up and occur again within a few days
    • you experience signs of skin injury, such as pain, swelling, or blistering where the product was applied

    Flammable■ Keep away from fire or flame

    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 (1-800-222-1222) right away.

  • Directions

    Adults and children over 12 years: ■ apply a thin layer to affected area
    ■ massage into painful area until thoroughly absorbed into skin
    ■ repeat as necessary, but no more than 3 to 4 times daily
    ■ IF MEDICINE COMES IN CONTACT WITH HANDS, WASH WITH SOAP AND WATER
    Children 12 years or younger: ■ ask a doctor

  • Inactive ingredients

    acrylates/C10-30 alkyl acrylate crosspolymer (6000 MPA.S), capsaicin, glycerin, isopropyl myristate, propylene glycol, SD alcohol, triethanolamine, water


    Inactive ingredients acrylates/C10-30 alkyl acrylate crosspolymer (60000 MPA.S), aloe barbadensis leaf juice, aminomethyl propanol, ceteth-10 phosphate, cetostearyl alcohol, Cyclomethicone 5, dicetyl phosphate, dimethicone 350, dimethicone/vinyl dimethicone
    crosspolymer (soft particle), disodium EDTA, ethylhexylglycerin, glyceryl 1 stearate, hydroxyethyl acrylate/sodium acryloyl dimethyl taurate copolymer (100000 MPA.S at 1.5%), isohexadecane,
    phenoxyethanol, SD alcohol, steareth-21, water

  • Questions or comments

    Call 1-866-326-1313

  • Principal Display Panel

    Pack

  • INGREDIENTS AND APPEARANCE
    HEALTHWISE MENTHOL 4% ROLL-ON 
    menthol liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71101-040
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL4 g  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    GLYCERIN (UNII: PDC6A3C0OX)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    CARBOMER 940 (UNII: 4Q93RCW27E)  
    CAMPHOR (NATURAL) (UNII: N20HL7Q941)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    ALCOHOL (UNII: 3K9958V90M)  
    ARNICA MONTANA FLOWER (UNII: OZ0E5Y15PZ)  
    WATER (UNII: 059QF0KO0R)  
    ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  
    CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    MELISSA OFFICINALIS LEAF (UNII: 50D2ZE9219)  
    ARCTIUM LAPPA WHOLE (UNII: 73070DU1LA)  
    GREEN TEA LEAF (UNII: W2ZU1RY8B0)  
    ILEX PARAGUARIENSIS LEAF (UNII: 1Q953B4O4F)  
    INDIAN FRANKINCENSE (UNII: 4PW41QCO2M)  
    METHYL METHACRYLATE/GLYCOL DIMETHACRYLATE CROSSPOLYMER (UNII: EG97988M5Q)  
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:71101-040-011 in 1 CARTON05/01/2024
    173 mL in 1 BOTTLE, WITH APPLICATOR; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01705/01/2024
    Labeler - Veridian Healthcare (830437997)
    Establishment
    NameAddressID/FEIBusiness Operations
    Nantong Health & Beyond Hygienic Products Inc421280161manufacture(71101-040)
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