Label: YORUN GERMICIDAL DISPOSABLE WIPES- isopropyl alcohol antibacterial wipes 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 October 24, 2020

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  • Active Ingredient

    ISOPROPYL ALCOHOL 55%

  • Purpose

    Antiseptic

  • Uses

    Decrease bacteria on the skin that could cause disease

    For use when soap and water are not available

  • Warnings

    For external use only. Flammable, keep away from heat or flame.

  • Do not use

    • on open skin wounds
  • WHEN USING

    When using this product, keep out of eyes, ears and mouth. In case of contact with eyes, rinse thoroughly with water immediately. If swallowed, get medical help or contact a Poison Control Center immediately. Discard used wipes immediately to prevent cross contamination. Children should be under adult supervision when using this product.

  • STOP USE

    Stop using and consult a doctor if irritation or rash occurs, these may be sighs of a serious condition.

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children. Not recommended for infants.

  • Directions for use

    • Open the cap. Pull out wipe and close the cap. Unfold and wipe hands, fingers and wrists thoroughly and allow to dry. For dirty hands, use first wipe to clean hands then discard wipe; sanitize with second wipe. Discard after single use. Make sure to close the cap firmly after use to retain moisture.
  • Other information

    • Store between 59-86°F (15-30°C). Avoid freezing and excessive heat above 104°F (40°C). May discolor some fabrics. Harmful to wood finishes and plastics. Lot number and expiry date can be found on label. Dispose of wipe in proper container after use. Do not flush.
  • Inactive ingredients

    PURE WATER and QUATERNARY AMMONIUM COMPOUNDS

  • Package Label - Principal Display Panel

    innermost package

  • INGREDIENTS AND APPEARANCE
    YORUN GERMICIDAL DISPOSABLE WIPES 
    isopropyl alcohol antibacterial wipes cloth
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:75428-602
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ISOPROPYL ALCOHOL (UNII: ND2M416302) (ISOPROPYL ALCOHOL - UNII:ND2M416302) ISOPROPYL ALCOHOL55   in 100 
    Inactive Ingredients
    Ingredient NameStrength
    N-ALKYL DIMETHYL BENZYL AMMONIUM CHLORIDE (C12-C18) (UNII: 9U1Q4T4ZYS)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:75428-602-0116 in 1 CARTON10/24/2020
    1160 in 1 DRUM; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A10/24/2020
    Labeler - Shandong BaiHe Sanitary Products Co., Ltd. (549556417)
    Registrant - Shandong BaiHe Sanitary Products Co., Ltd. (549556417)
    Establishment
    NameAddressID/FEIBusiness Operations
    Shandong BaiHe Sanitary Products Co., Ltd.549556417manufacture(75428-602)
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