Label: COOL PAP CATAPLASMA- methyl salicylate, l-menthol, dl-camphor, mentha oil, thymol 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 January 17, 2022

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  • ACTIVE INGREDIENT

    Methyl salicylate

    ℓ-Menthol

    dl-Camphor

    Mentha oil

    Thymol

  • INACTIVE INGREDIENT

    Kaolin

    Zinc oxide

    Titanium oxide

    Gelatin

    Glycerin

    Liquid paraffin

    Carboxymethylcellulose sodium

    Polybutene

    Sodium polyacrylate

    Butylated hydroxy toluene

    Polysorbate 60

    Methoxyethylene maleicanhydride copolymer

    Citric acid hydrate

    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
    COOL PAP CATAPLASMA 
    methyl salicylate, l-menthol, dl-camphor, mentha oil, thymol patch
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72988-0008
    Route of AdministrationTRANSDERMAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    THYMOL (UNII: 3J50XA376E) (THYMOL - UNII:3J50XA376E) THYMOL17.5 mg  in 17.5 g
    PEPPERMINT OIL (UNII: AV092KU4JH) (PEPPERMINT - UNII:V95R5KMY2B) PEPPERMINT OIL87.5 mg  in 17.5 g
    LEVOMENTHOL (UNII: BZ1R15MTK7) (LEVOMENTHOL - UNII:BZ1R15MTK7) LEVOMENTHOL17.5 mg  in 17.5 g
    CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET) (CAMPHOR (SYNTHETIC) - UNII:5TJD82A1ET) CAMPHOR (SYNTHETIC)122.5 mg  in 17.5 g
    METHYL SALICYLATE (UNII: LAV5U5022Y) (SALICYLIC ACID - UNII:O414PZ4LPZ) METHYL SALICYLATE262.5 mg  in 17.5 g
    Inactive Ingredients
    Ingredient NameStrength
    KAOLIN (UNII: 24H4NWX5CO)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:72988-0008-117.5 g in 1 POUCH; Type 0: Not a Combination Product03/29/2019
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34803/23/2019
    Labeler - Lydia Co., Ltd. (695735569)
    Registrant - Lydia Co., Ltd. (695735569)
    Establishment
    NameAddressID/FEIBusiness Operations
    Lydia Co., Ltd.695735569label(72988-0008) , manufacture(72988-0008)
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