Label: ZENOL MILD HOT- methyl salicylate, vanillyl nonylamide patch

  • 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 November 6, 2021

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  • ACTIVE INGREDIENT

    Methyl salicylate

    Vanillyl N-nonylamide (NONIVAMIDE)

  • INACTIVE INGREDIENT

    Kaolin,Zine Oxide,Titanium Oxide,Galatin,Glycerin,Liquid Paraffin,Polybutene,Sodium Polyacrylate,Rubber Latex,Purified Water

  • PURPOSE

    For temporary relief of minor aches & pains of muscles & joints Associated with:

    • Arthritis •Simple backache •Strains •Bruises •Sprains

  • KEEP OUT OF REACH OF CHILDREN

    keep out of reach of the children

  • INDICATIONS & USAGE

    Adults and children 12 years of age and over:

    •Clean and dry affected area •Remove patch from film

    •Apply to affected area not more than 3 to 4 times daily

    •Remove patch from the skin after at most 8-hour application

    Children under 12 years of age:

  • WARNINGS

    use only as directed
    do not bandage tightly or use with a healing pad
    avoid contact with the eyes and mucous membranes
    do not apply to wounds or damaged skin

  • DOSAGE & ADMINISTRATION

    for external use only

  • PRINCIPAL DISPLAY PANEL

    label

  • INGREDIENTS AND APPEARANCE
    ZENOL MILD HOT 
    methyl salicylate, vanillyl nonylamide patch
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72988-0025
    Route of AdministrationTRANSDERMAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    NONIVAMIDE (UNII: S846B891OR) (NONIVAMIDE - UNII:S846B891OR) NONIVAMIDE1.75 mg  in 14 g
    METHYL SALICYLATE (UNII: LAV5U5022Y) (SALICYLIC ACID - UNII:O414PZ4LPZ) METHYL SALICYLATE105 mg  in 14 g
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    KAOLIN (UNII: 24H4NWX5CO)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:72988-0025-114 g in 1 POUCH; Type 0: Not a Combination Product10/01/2021
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34810/01/2021
    Labeler - Lydia Co., Ltd. (695735569)
    Registrant - Lydia Co., Ltd. (695735569)
    Establishment
    NameAddressID/FEIBusiness Operations
    Lydia Co., Ltd.695735569manufacture(72988-0025)
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