Label: SANITIZING WIPES- hand sanitizer 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 12, 2020

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  • Active Ingredient(s)

    Benzalkonium chloride>=0.1%, Antimicrobial agent

  • Purpose

    Antiseptic, Hand Sanitizer

  • Use

    Hand Sanitizer to help reduce bacteria that potentially can cause disease. For use when soap and water are not available.

  • Warnings

    For external use only.

  • 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 develops and continues for more than 72 hours.

  • 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

    • Adults and children 2 years and over.
    • Apply to hands allow to dry without wiping.
  • Other information

    • Store between 15-30C (59-86F)
    • Avoid freezing and excessive heat above 40C (104F)
  • Inactive ingredients

    Water(aqua), Didecyl dimethy ammonium chloride, T5(Glycerin), T3(Aloe), T6(VE), Tributyl phosphate, Citric acid, Alcohol.

  • Package Label - Principal Display Panel

    30 Individually Packed Wipes in 1 BOX NDC: 79247-812-01 Package Label

  • Package Label - Principal Display Panel

    20 Wipes in 1 BOX NDC: 79247-812-02 Package Label

  • Package Label - Principal Display Panel

    50 Wipes in 1 BOX NDC: 79247-812-03 Package Label

  • Package Label - Principal Display Panel

    80 Wipes in 1 BOX NDC: 79247-812-04 Package Label

  • INGREDIENTS AND APPEARANCE
    SANITIZING WIPES 
    hand sanitizer cloth
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:79247-812
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE0.1 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    GLYCERIN (UNII: PDC6A3C0OX) 0.1 g  in 100 g
    ALOE (UNII: V5VD430YW9) 0.0025 g  in 100 g
    WATER (UNII: 059QF0KO0R) 94.915 g  in 100 g
    ALCOHOL (UNII: 3K9958V90M) 4.7 g  in 100 g
    TOCOPHEROL (UNII: R0ZB2556P8) 0.0025 g  in 100 g
    TRI-N-BUTYL PHOSPHATE (UNII: 95UAS8YAF5) 0.01 g  in 100 g
    DIDECYLDIMONIUM CHLORIDE (UNII: JXN40O9Y9B) 0.16 g  in 100 g
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL) 0.01 g  in 100 g
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:79247-812-01183 g in 1 BOX; Type 0: Not a Combination Product08/12/2020
    2NDC:79247-812-02122 g in 1 BOX; Type 0: Not a Combination Product08/12/2020
    3NDC:79247-812-03338 g in 1 BOX; Type 0: Not a Combination Product08/12/2020
    4NDC:79247-812-04540 g in 1 BOX; Type 0: Not a Combination Product08/12/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A08/12/2020
    Labeler - Ivy Rose Inc. (037401255)
    Registrant - Ivy Rose Inc. (037401255)
    Establishment
    NameAddressID/FEIBusiness Operations
    Jiangsu Terra Medical Technology Co. Ltd.421340473manufacture(79247-812)
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