Label: ROLHEI 75 PERCENT ETHANOL WET 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 June 16, 2020

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  • ACTIVE INGREDIENT

    Ethyl Alcohol 75% v/v

  • INACTIVE INGREDIENTS

    Water, Cetylpyridinium chloride, Glycerin, Polysorbate, Caprylhydroxamic acid, Citric acid

  • PURPOSE

    ANTISEPTIC

  • WARNINGS

    For external use only. Flammable. Keep away from heat or flame
    --------------------------------------------------------------------------------------------------------
    Do not use
    • in children less than 2 months of age
    • on open skin wounds
    --------------------------------------------------------------------------------------------------------
    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.

  • Uses

    Hand sanitizing wipes to help reduce bacteria that potentially can cause disease.

  • Directions

    ■ Wet hands thoroughly with product and allow to dry without wiping
    ■ Do not flush
    ■ Children under 2 years ask a doctor before use

  • Other information

    ■ Read the directions and warnings before use
    ■ Store between 15-30℃(59-89℉)
    ■ Avoid freezing and excessive heat above 40℃(104 ℉)

  • PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

    Image of packet

  • INGREDIENTS AND APPEARANCE
    ROLHEI 75 PERCENT ETHANOL WET WIPE 
    alcohol cloth
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:78580-010
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL75   in 100 
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    CETYLPYRIDINIUM CHLORIDE (UNII: D9OM4SK49P)  
    Glycerin (UNII: PDC6A3C0OX)  
    CAPRYLHYDROXAMIC ACID (UNII: UPY805K99W)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:78580-010-01100 in 1 PACKET; Type 0: Not a Combination Product06/01/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E06/01/2020
    Labeler - Glory Co., Ltd. (688492036)
    Registrant - Glory Co., Ltd. (688492036)
    Establishment
    NameAddressID/FEIBusiness Operations
    Glory Co., Ltd.688492036manufacture(78580-010)
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