Label: BIOGENO CARE HAND SANITIZER GEL (ETHANOL)- 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 March 30, 2021

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  • Active Ingredient(s)

    Alcohol 70% v/v. Purpose: Antimicrobial

  • Purpose

    Antimicrobial, Hand Sanitizer

  • Use

    Hand sanitizer to help reduce bacteria on the skin.
    Recommended for repeated use.

  • 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

    • Put enough product in your palm to cover hands and rub hands together briskly until dry.
    • Children under 6 years of age should be supervised when using this product.
    • Not recommended for infants.
  • Other information

    • Store at room temperature (33.8oF-86oF, 1oC-30oC) and avoid cold or dry place.
    • May discolor certain fabrics or surfaces.
    • Harmful to wood finishes and plastics.
  • Inactive ingredients

    Aloe Vera Gel, Carbomer, Fragrance (Lemon), Glycerin, Green Tea Extract, Purified Water, Rosa Damascena (Rose) Flower Water, Sodium Hyaluronate, Triethanolamine.

  • Package Label - Principal Display Panel

    Biogeno Care Hand Sanitizer Gel 500mL

  • INGREDIENTS AND APPEARANCE
    BIOGENO CARE HAND SANITIZER GEL (ETHANOL) 
    alcohol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:77637-400
    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
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    GREEN TEA LEAF (UNII: W2ZU1RY8B0)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    WATER (UNII: 059QF0KO0R)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
    CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)  
    Product Characteristics
    Color    Score    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:77637-400-01500 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product03/30/2021
    Image of Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A03/30/2021
    Labeler - DERMACOS KOREA (695625857)
    Registrant - DERMACOS KOREA (695625857)
    Establishment
    NameAddressID/FEIBusiness Operations
    DERMACOS KOREA695625857manufacture(77637-400)
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