Label: MAINCLEAN DISINFECTANT WIPES 11060208- disinfection wet wipes 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 April 20, 2020

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  • Active ingredient

    Alcohol, 15% v/v, antiseptic

  • Inactive ingredient

    Cetylpyridinium Chloride

    Propylene Glycol

    Phenoxyethanol

    Glycerin

    Ethylhexylglycerin

    Water

  • Purpose

    This product is used to wipe hands, faces, skins, etc. It can also be used to clean many kinds of places.

  • When using

    This product is used to wipe hands, faces, skins, etc. It can also be used to clean many kinds of places.

  • Do not use

    Use only as directed.
    Do not use for cases not directed.

  • Stop use

    Stop use if the product's volatile gases cause discomfort, or if you experience respiratory irritation such as cough, asthma, or difficulty breathing.

  • Keep out of reach of children

    Keep out of reach of children.

  • Indications & usage

    This product is used to wipe hands, faces, skins, etc. It can also be used to clean many kinds of places.

  • Dosage & administration

    Use it as needed, after following the usage instructions.

    For external use only.

  • Warnings

    Do not apply this product to red and swollen skin, wound or any part sensitive to it.
    Keep this product out of children’s reach in case they might eat it.
    Do not throw this product into the toilet as it cannot dissolve.

  • Package label. Principal display panel

    2011

  • INGREDIENTS AND APPEARANCE
    MAINCLEAN DISINFECTANT WIPES 11060208 
    disinfection wet wipes patch
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:75162-2011
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL15   in 100 
    Inactive Ingredients
    Ingredient NameStrength
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3) 0.25 
    WATER (UNII: 059QF0KO0R) 84.585 
    CETYLPYRIDINIUM CHLORIDE ANHYDROUS (UNII: 6BR7T22E2S) 0.075 
    PHENOXYETHANOL (UNII: HIE492ZZ3T) 0.05 
    GLYCERIN (UNII: PDC6A3C0OX) 0.025 
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P) 0.015 
    Product Characteristics
    Color    Score    
    ShapeFREEFORMSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:75162-2011-160 in 1 PACKAGE; Type 0: Not a Combination Product04/20/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A04/20/2020
    Labeler - Shandong Mainclean Medical Products Co., Ltd. (418445935)
    Registrant - A03 Lab of BTS (548009541)
    Establishment
    NameAddressID/FEIBusiness Operations
    Shandong Mainclean Medical Products Co., Ltd.418445935label(75162-2011) , manufacture(75162-2011)
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