Label: ANTIBACTERIAL HAND SANITIZER- alcohol hand sanitizer 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 30, 2020

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  • Active Ingredient(s)

    Ethyl alcohol 75% v/v. Purpose: Antimicrobial

  • Purpose

    Antibacterial

  • Use

    For handwashing to decrease bacteria on the skin.

  • Warnings

    Flammable. Keep away from fire or flame.

  • Do not use

    For external use only.

  • WHEN USING

    When using this product avoid contact with eyes.

    If contact occurs, rinse eyes thoroughly with water.

  • STOP USE

    Stop use and ask a doctor if irritation or rash develops and continues for 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

    • Take a palmful (5grams) of product in one hand.
    • Spread on both hands and rub into skin until dry (approximately 1 to 2 minutes).
  • Other information

    • Do not store above 86℉ (30℃)
    • May discolor some fabrics
    • Harmful to wood finishes and plastics
  • Inactive ingredients

    Water, Glycerin, Carbomer, Fragrance.

  • Package Label - Principal Display Panel

    76806-10176806-10476806-106

  • INGREDIENTS AND APPEARANCE
    ANTIBACTERIAL HAND SANITIZER 
    alcohol hand sanitizer gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:76806-104
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL177.75 mL  in 237 mL
    Inactive Ingredients
    Ingredient NameStrength
    GLYCERIN (UNII: PDC6A3C0OX)  
    WATER (UNII: 059QF0KO0R)  
    CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)  
    CLOVE (UNII: K48IKT5321)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:76806-104-01237 mL in 1 BOTTLE; Type 0: Not a Combination Product04/30/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A04/30/2020
    ANTIBACTERIAL HAND SANITIZER 
    alcohol hand sanitizer gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:76806-106
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL266.25 mL  in 355 mL
    Inactive Ingredients
    Ingredient NameStrength
    GLYCERIN (UNII: PDC6A3C0OX)  
    WATER (UNII: 059QF0KO0R)  
    CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)  
    CLOVE (UNII: K48IKT5321)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:76806-106-01355 mL in 1 BOTTLE; Type 0: Not a Combination Product04/30/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A04/30/2020
    ANTIBACTERIAL HAND SANITIZER 
    alcohol hand sanitizer gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:76806-101
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL45 mL  in 60 mL
    Inactive Ingredients
    Ingredient NameStrength
    GLYCERIN (UNII: PDC6A3C0OX)  
    WATER (UNII: 059QF0KO0R)  
    CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)  
    CLOVE (UNII: K48IKT5321)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:76806-101-0160 mL in 1 BOTTLE; Type 0: Not a Combination Product04/30/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A04/30/2020
    Labeler - Logomark Inc (829978766)
    Registrant - A03 Lab of BTS (548009541)
    Establishment
    NameAddressID/FEIBusiness Operations
    Shanghai Chuangshi Industry Group Co., Ltd546872672manufacture(76806-101, 76806-104, 76806-106)
    Establishment
    NameAddressID/FEIBusiness Operations
    Logomark Inc829978766label(76806-101, 76806-104, 76806-106)
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