Label: KITOX BEAUTY GREEN HAND SANITIZER GEL- 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 May 20, 2020

If you are a consumer or patient please visit this version.

  • 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 below 100oF (43oC).
    • May discolor certain fabrics or surfaces.
    • Harmful to wood finishes and plastics.
  • Inactive ingredients

    Aloe Vera Gel, Carbomer, Glycerin, Green Tea Extract, Licorice (Glycyrrhiza Galbra) Extract, Menthol, Shrubby Sophora (Sophora Flavescens) Root Extract, Sodium Hyaluronate, Triethanolamine, Water (Aqua).

  • Package Label - Principal Display Panel

    KITOX Beauty Green Hand Sanitizer

  • INGREDIENTS AND APPEARANCE
    KITOX BEAUTY GREEN HAND SANITIZER GEL 
    alcohol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:77637-300
    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)  
    MENTHOL (UNII: L7T10EIP3A)  
    GLYCYRRHIZA GLABRA WHOLE (UNII: M1F96IE0ZC)  
    GREEN TEA LEAF (UNII: W2ZU1RY8B0)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    WATER (UNII: 059QF0KO0R)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
    CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)  
    SOPHORA FLAVESCENS ROOT (UNII: IYR6K8KQ5K)  
    Product Characteristics
    Color    Score    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:77637-300-011 in 1 BOX05/20/2020
    1500 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product
    2NDC:77637-300-021 in 1 BOX05/20/2020
    2100 mL in 1 TUBE; Type 0: Not a Combination Product
    3NDC:77637-300-032000 mL in 1 PACKAGE; Type 0: Not a Combination Product05/20/2020
    Image of Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A05/13/2020
    Labeler - DERMACOS KOREA (695625857)
    Registrant - DERMACOS KOREA (695625857)
    Establishment
    NameAddressID/FEIBusiness Operations
    DERMACOS KOREA695625857manufacture(77637-300)