Label: GERMICIDAL DISPOSABLE WIPE- isopropyl alcohol cloth

  • 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 August 4, 2020

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  • Active Ingredient(s)

    ISOPROPYL ALCOHOL , N-ALKYL DIMETYL ETHYLBENZYL AMMONIUM CHLORIDES,N-ALKYL DIMETHYL BENZYL BENZYL AMMONIUM CHLORIDES, Purpose: Antiseptic

  • Purpose

    Antiseptic,Wipes

  • Use

    1.FOR YOUE FIRST USAGE, LIFT UP THE WHOLE LID.

    2.PULL OUT WIPES FROM CENTER OF THE ROLL.

    3.CLOSE LID TO RETAIN THE WIPES MOISTURE.

  • Warnings

    • FOR EXTERNAL USE ONLY.
      • AVOID USING ON EYES OR WOUNED SKIN.
      • STORE IN A COOL DRY PLACE.
      • KEEP OUT OF THE REACH OF CHILDREN.
      • AVOID DIRECT SUN EXPOSURE.
      • IF IRRITATIONOCCUSR ,STOP USAGE AND CONSULT A DOCTOR.
      • DO NOT USE IF YOU ARE ALLERGIC TO ANY OF THE INGREDIENTS.
      • DO NOT DIPOSE OF WIPES IN TOILETS.
  • Do not use

    • IF YOU ARE ALLERGIC TO ANY OF THE INGREDIENTS
  • WHEN USING

    When using this product keep out of eyes, ears, and mouth. In case of contact with eyes, rinse eyes thoroughly with water.
    Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition.
    Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

  • STOP USE

    Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition.

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

  • Directions

    • THESE SINGLE USE ,DISPOSABLE VIRUCIDAL AND BACTERICIDAL WIPES USE A QUATERNARY AND HIGH-ALCOHOL FORMULA TO QUICKLY CLEAN AND DISINFECT SURFACES IN ONE STEP . THEY ARE SUITABLE FOR USE IN HEALTHCARE OR WORKPLACE SCENARIOS AND ARE NOT FOR USE ON SKIN .EACH BUCKET CONTAINS 160 DURABLE WIPES.
    • ACTIVE INGREDIENTS: QUATERNARY AMMONIUM AND ISOPROPYL ALCOHOL(IPA)
    • VIRUCIDAL AND BACTERICIDAL WIPES DISINFECT AND CLEAN IN ONE STEP
    • CAN BE USED ON A BROAD RANGE OF SURFACES AND EQUIPMENT IN HEALTHCARE OR WORKPLACE SCENARIOS
    • QUATERNARY/HIGH-ALCOHOL FORMULA
  • Other information

    • AVOID DIRECT CONTACT WITH EYES.IN CASE OF CONTACT WITH EYES,RINSE IMMEDIATELY WITH CLEAN WATER.
    • IF YOU FIND ANY DISCOMFORT OR ALLERGIC REACTION,PLEASE STOP USING IN IMMEDIATELY.
    • PLEASE KEEP PRODUCT AT ROOM TEMPERTURE AND AWAY FROM LIGHT.
    • SEE SEAL FOR PRODUCTION DATE. PLEASE DISCARD AFTER 2 YEARS.
  • Inactive ingredients

    WATER,ALOE BARDADENSIS LEAF EXTRACT, VITAMIN E.

  • Package Label - Principal Display Panel

    160 CLOTH NDC:55482-160-01

    160 CLOTH LABEL

  • INGREDIENTS AND APPEARANCE
    GERMICIDAL DISPOSABLE WIPE 
    isopropyl alcohol cloth
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55482-160
    Route of AdministrationEXTRACORPOREAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ISOPROPYL ALCOHOL (UNII: ND2M416302) (ISOPROPYL ALCOHOL - UNII:ND2M416302) ISOPROPYL ALCOHOL55 mL  in 100 
    N-ALKYL ETHYLBENZYL DIMETHYL AMMONIUM CHLORIDE (C12-C14) (UNII: G258TFN61X) (N-ALKYL ETHYLBENZYL DIMETHYL AMMONIUM (C12-C14) - UNII:85440928RV) N-ALKYL ETHYLBENZYL DIMETHYL AMMONIUM CHLORIDE (C12-C14)0.25 g  in 100 
    N-ALKYL ETHYLBENZYL DIMETHYL AMMONIUM (C12-C14) (UNII: 85440928RV) (N-ALKYL ETHYLBENZYL DIMETHYL AMMONIUM (C12-C14) - UNII:85440928RV) N-ALKYL ETHYLBENZYL DIMETHYL AMMONIUM (C12-C14)0.25 g  in 100 
    Inactive Ingredients
    Ingredient NameStrength
    .ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)  
    ALOE (UNII: V5VD430YW9)  
    WATER (UNII: 059QF0KO0R)  
    Product Characteristics
    Color    Score    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:55482-160-01160 in 1 PAIL; Type 0: Not a Combination Product03/30/2020
    Image of Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A03/30/2020
    Labeler - Dongguan Zhongcheng Sanitary Commodities Co., Ltd. (554532875)
    Registrant - Dongguan Zhongcheng Sanitary Commodities Co., Ltd. (554532875)
    Establishment
    NameAddressID/FEIBusiness Operations
    Dongguan Zhongcheng Sanitary Commodities Co., Ltd.554532875manufacture(55482-160)
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