Label: AUBE HAND SANITIZER- alcohol gel

  • 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 April 28, 2020

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  • Active ingredient

    Alcohol (70%)

  • Purpose

    Antiseptic

  • Uses

    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 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.

  • Other information

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

    Water, Glycerin, Artemisia Princeps Leaf Extract,Houttuynia Cordata Extract, Astragalus Membranaceus Extract, Centella Asiatica Extract, Oryza Sativa (Rice) Bran Extract, Scutellaria Baicalensis Root Extract, Carbomer, Triethanolamine, 1,2-Hexanediol, Fragrance

  • 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.
  • Aube Hand Sanitizer

    aube hand sanitizer

  • INGREDIENTS AND APPEARANCE
    AUBE HAND SANITIZER 
    alcohol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:76656-100
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL70 mL  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    TROLAMINE (UNII: 9O3K93S3TK)  
    WATER (UNII: 059QF0KO0R)  
    ARTEMISIA PRINCEPS LEAF (UNII: SY077EW02G)  
    RICE BRAN (UNII: R60QEP13IC)  
    SCUTELLARIA BAICALENSIS ROOT (UNII: 7J95K7ID2S)  
    CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)  
    1,2-HEXANEDIOL (UNII: TR046Y3K1G)  
    HOUTTUYNIA CORDATA FLOWERING TOP (UNII: RH041UUZ22)  
    CENTELLA ASIATICA (UNII: 7M867G6T1U)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:76656-100-0170 mL in 1 TUBE; Type 0: Not a Combination Product04/28/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E04/28/2020
    Labeler - K BOOM BEAUTY .INC (094860828)
    Establishment
    NameAddressID/FEIBusiness Operations
    EASTLAB INC694781476manufacture(76656-100)
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