Label: HOT PAP CATAPLASMA- methyl salicylate, vanillyl nonylamide patch

  • NDC Code(s): 72988-0007-1, 72988-0007-2
  • Packager: Lydia Co., Ltd.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved drug other

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Drug Label Information

Updated July 5, 2023

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  • ACTIVE INGREDIENT

    Methyl salicylate

    Vanillyl nonylamide

  • INACTIVE INGREDIENT

    Kaolin

    Glycerin

    Liquid paraffin

    Gelatin

    Titanium oxide

    Carboxymethylcellulose sodium

    Zinc oxide

    Methoxyethylene maleicanhydride copolymer

    Polybutene

    Citric acid hydrate

    Sodium polyacrylate

    Thymol

    Butyl paraben

    Butylated hydroxy toluene

    Polysorbate 60

    Isopropyl myristate

    Natural rubber latex

    Purified water

    Nonwoven fabric

    Polyester film

  • PURPOSE

    Topical Analgesic

    Temporarily relieves minor pain associated with - muscular pain - joint pain - backache - bruise - sprain

  • KEEP OUT OF REACH OF CHILDREN

    keep out of reach of the children

  • INDICATIONS & USAGE

    Adults and children 12 years of age and over: apply to affected area not more than 3 to 4 times daily.

    Children under 12 years of age: do not use, consult a doctor
    For easy application: partially peel back protective film and apply exposed patch to the site of pain.
    Carefully remove remaining film while pressing patch to skin for secure adhesion.

  • 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
    HOT PAP CATAPLASMA 
    methyl salicylate, vanillyl nonylamide patch
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72988-0007
    Route of AdministrationTRANSDERMAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    METHYL SALICYLATE (UNII: LAV5U5022Y) (SALICYLIC ACID - UNII:O414PZ4LPZ) METHYL SALICYLATE58.3 mg  in 13.4 g
    NONIVAMIDE (UNII: S846B891OR) (NONIVAMIDE - UNII:S846B891OR) NONIVAMIDE5 mg  in 13.4 g
    Inactive Ingredients
    Ingredient NameStrength
    THYMOL (UNII: 3J50XA376E)  
    KAOLIN (UNII: 24H4NWX5CO)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:72988-0007-25 in 1 PACKAGE03/29/2019
    1NDC:72988-0007-113.4 g in 1 PATCH; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other03/29/2019
    Labeler - Lydia Co., Ltd. (695735569)
    Registrant - Lydia Co., Ltd. (695735569)
    Establishment
    NameAddressID/FEIBusiness Operations
    Lydia Co., Ltd.695735569label(72988-0007) , manufacture(72988-0007)
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