Label: B CLEAN HAND SANITIZER- ethyl 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 August 7, 2020

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  • Active Ingredient

    Ethyl Alcohol 75% v/v. Purpose: Antiseptic

  • Purpose

    Antiseptic, Hand Sanitizer

  • Use

    Hand Sanitizer to help reduce bacteria that potentially can cause disease.

  • 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.

  • 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 59º-86ºF (15º-30ºC)
    • Avoid freezing and excessive heat above 104ºF (40ºC)
    • May discolor certain fabrics
  • Inactive Ingredients

    Aqua, Carbomer, Denatonium Benzoate, Isopropanolamine, Mentha Piperita Extract, Propylene Glycol, Salvia Officinalis Leaf Extract, Verbena Officinalis Leaf Extract

  • Package Label - Principal Display Panel

    B CLEAN

    HAND SANITIZER

    ALCOHOL-BASED GEL

    moisturizing

    alcohol 75%

    Distributed by: Heth LLC
    7522 Campbell Road
    Suite 113 #272
    Dallas TX 75248
    +1 844 989 3111

    MADE IN BRAZIL

    NDC 78310-100-01

  • INGREDIENTS AND APPEARANCE
    B CLEAN HAND SANITIZER 
    ethyl alcohol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:78310-100
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL3080 g  in 4400 g
    Inactive Ingredients
    Ingredient NameStrength
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    MENTHA PIPERITA (UNII: 79M2M2UDA9)  
    ISOPROPANOLAMINE (UNII: UE40BY1BZW)  
    VERBENA OFFICINALIS LEAF (UNII: 3289NQE84P)  
    DENATONIUM BENZOATE (UNII: 4YK5Z54AT2)  
    CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)  
    SAGE (UNII: 065C5D077J)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:78310-100-014400 g in 1 BOTTLE; Type 0: Not a Combination Product06/12/2020
    2NDC:78310-100-023200 g in 1 BOTTLE; Type 0: Not a Combination Product07/31/2020
    3NDC:78310-100-033200 g in 1 BOTTLE, PUMP; Type 0: Not a Combination Product07/31/2020
    4NDC:78310-100-051660 g in 1 BOTTLE, PUMP; Type 0: Not a Combination Product07/31/2020
    5NDC:78310-100-041660 g in 1 BOTTLE; Type 0: Not a Combination Product07/31/2020
    6NDC:78310-100-06865 g in 1 BOTTLE, PUMP; Type 0: Not a Combination Product07/31/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A06/12/2020
    Labeler - HETH LLC (080815601)
    Registrant - AGE DO BRASIL INDUSTRIA E COMERCIO LTDA. (920307841)
    Establishment
    NameAddressID/FEIBusiness Operations
    AGE DO BRASIL INDUSTRIA E COMERCIO LTDA.920307841manufacture(78310-100)
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