Label: DISINFECTING WIPE- 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 November 22, 2022

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  • SPL UNCLASSIFIED SECTION

    Disinfecting wipe

  • Active Ingredient

    75%ALCOHOL .Bacteriostasis, Sterilization

  • Purpose

    Soft nonwoven fabrics contain special essential ingredients. Alcoro is free, mixed with purewater. Effective cleaning. You feel comfortable with fresh cleaning wipes.

  • Use

    Bacteriostasis, Sterilization

    pull the protective seal back in the direction shown and pull out the wipes as required.Close the seal after each use and keep the wipes moist.

    Do not expose to direct sunlight orHigh temperature, for externaluse only.

  • Warnings

    1.Keep away from the baby.
    2.Avoid contact with eyes orwounds.
    3. Don't flush the wipes into the toilet.
    4.Do not expose to direct sunlight orHigh temperature, for externaluse only.

  • DO NOT USE

    1.Keep away from the baby.
    2.Avoid contact with eyes orwounds.
    3. Don't flush the wipes into the toilet.
    4.Do not expose to direct sunlight orHigh temperature, for externaluse only.

  • WHEN USING

    1.Keep away from the baby.
    2.Avoid contact with eyes orwounds.
    3.Don't flush the wipes into the toilet.
    4.Do not expose to direct sunlight orHigh temperature, for externaluse only.

  • KEEP OUT OF REACH OF CHILDREN

    Keep away from the baby.

  • DOSAGE & ADMINISTRATION

    Pull the protective seal back in the direction shown and pull out the wipes as required.close the seal after each use and keep the wipes moist.

  • STORAGE AND HANDLING

    Do not expose to direct sunlight orHigh temperature.
    Close the seal after each use and keep the wipes moist.

  • INACTIVE INGREDIENT

    Water,BENZETHONIUM CHLORIDE

  • PRINCIPAL DISPLAY PANEL

    label

  • INGREDIENTS AND APPEARANCE
    DISINFECTING WIPE 
    alcohol cloth
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:83130-101
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL1 mL  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    BENZETHONIUM CHLORIDE (UNII: PH41D05744)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:83130-101-0110 mL in 1 BAG; Type 0: Not a Combination Product11/23/2022
    2NDC:83130-101-0220 mL in 1 BAG; Type 0: Not a Combination Product11/23/2022
    3NDC:83130-101-0330 mL in 1 BAG; Type 0: Not a Combination Product11/23/2022
    4NDC:83130-101-0440 mL in 1 BAG; Type 0: Not a Combination Product11/23/2022
    5NDC:83130-101-0550 mL in 1 BAG; Type 0: Not a Combination Product11/23/2022
    6NDC:83130-101-0670 mL in 1 BAG; Type 0: Not a Combination Product11/23/2022
    7NDC:83130-101-0780 mL in 1 BAG; Type 0: Not a Combination Product11/23/2022
    8NDC:83130-101-08100 mL in 1 BAG; Type 0: Not a Combination Product11/23/2022
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A11/23/2022
    Labeler - Linquan Lefei sanitary products Co.,Ltd (713883658)
    Registrant - Linquan Lefei sanitary products Co.,Ltd (713883658)
    Establishment
    NameAddressID/FEIBusiness Operations
    Linquan Lefei sanitary products Co.,Ltd713883658manufacture(83130-101)
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