Label: HYGIENIUM HAND SANITIZER WIPES- alcohol cloth

  • Category: HUMAN OTC DRUG LABEL

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 July 21, 2021

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  • SPL UNCLASSIFIED SECTION

    This is a hand sanitizer manufactured according to the Temporary Policy for Preparation of Certain Alcohol-Based Hand Sanitizer Products During the Public Health Emergency (CoViD-19); Guidance for Industry.

    The hand sanitizer is manufactured using only the following United States Pharmacopoeia (USP) grade ingredients in the preparation of the product (percentage in final product formulation) consistent with World Health Organization (WHO) recommendations:

    1. Alcohol (ethanol) (USP or Food Chemical Codex (FCC) grade) (80%, volume/volume (v/v)) in an aqueous solution denatured according to Alcohol and Tobacco Tax and Trade Bureau regulations in 27 CFR part 20.
    2. Glycerol (1.45% v/v).
    3. Hydrogen peroxide (0.125% v/v).
    4. Sterile distilled water or boiled cold water.

    The firm does not add other active or inactive ingredients. Different or additional ingredients may impact the quality and potency of the product.

  • Active Ingredient(s)

    Alcohol 70% v/v. Purpose: Antiseptic

    D-gluconic acid 0.2%v/v Purpose:Antiseptic

  • 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. Flammable. Keep away from heat or flame

  • Do not use

    • in children less than 2 months of age
    • on open skin wounds
  • 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

    • Place enough product on hands to cover all surfaces. Rub hands together until dry.
    • Supervise children under 6 years of age when using this product to avoid swallowing.
  • Other information

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

    glycerin, hydrogen peroxide, purified water USP

  • Package Label - Principal Display Panel

    15pc Hand Sanitizer wipes15pc NDC:81592-1939-9

  • INGREDIENTS AND APPEARANCE
    HYGIENIUM HAND SANITIZER WIPES 
    alcohol cloth
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:81592-1939
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    .BETA.-D-GLUCOURONIC ACID (UNII: 00A9JB14O6) (.BETA.-D-GLUCOURONIC ACID - UNII:00A9JB14O6) .BETA.-D-GLUCOURONIC ACID0.36 g  in 100 mL
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL70 mL  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    GLYCERIN (UNII: PDC6A3C0OX) 1.45 mL  in 100 mL
    COCO-BETAINE (UNII: 03DH2IZ3FY)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:81592-1939-915 in 1 PACKET03/30/2020
    128 mL in 1 PACKET; Type 0: Not a Combination Product
    2NDC:81592-1939-140 in 1 PACKET03/30/2020
    286 mL in 1 PACKET; Type 0: Not a Combination Product
    3NDC:81592-1939-324 in 1 PACKET03/30/2020
    352 mL in 1 PACKET; Type 0: Not a Combination Product
    4NDC:81592-1939-5100 in 1 PACKET03/30/2020
    4230 mL in 1 PACKET; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A03/30/2020
    Labeler - Grande Gloria Production S.A. (534041167)
    Registrant - Grande Gloria Production S.A. (534041167)
    Establishment
    NameAddressID/FEIBusiness Operations
    Grande Gloria Production S.A.534041167manufacture(81592-1939)
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