Label: GEL INSTANT HAND SANITIZER- alcohol soap

  • 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 January 16, 2019

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  • ACTIVE INGREDIENT

    Active Ingredients / Ingrédient actif

    Ethyl Alcohol 70% v/v

    Alcool éthylique 70% v/v

  • PURPOSE

    Purpose / Objectif

    Antibacterial Agent

    Agent antibactérien

  • INDICATIONS & USAGE

    Uses / Utilisations: For handwashing to help reduce bacteria on the skin. Not for professional use in healthcare or food handling premises. / Pour le lavage des mains, afin de réduire les bactéries sur la peau. Ne pas utiliser à des fins professionelles dans les locaux de soins de santé ou de manipulation des aliments.

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children.

    Garder hors de portée des enfants.

  • WARNINGS

    Warnings / Avertissements :

    For external use only. FLAMMABLE. Keep away from heat or flame. Avoid contact with eyes. If eye contact occurs, flush eyes with water. Stop use if, in rare instances, redness or irritation develops. If condition persists for more than 72 hours, consult a physician. /

    Pour usage externe seulement. INFLAMMABLE. Ne pas mettre a proximite d'un feu ou d'une flamme. Ne pas mettre dans les yeux. En cas de contact avec les yeux, rincer avec l'eau. Arrêtex l'utilisation en cas rares d'irritation ou de rougeru. Si les symptômes persistent plus de 72 heures, consultez en médecin. Garder hors de portée des enfants. En cas d'ingestion, consultez un médecin ou un centre antipoison.

  • DOSAGE & ADMINISTRATION

    Directions / Mode d'emploi : Apply a small amount to palm. Briskly rub, covering hand with product until dry. / Verser une petite quantite dans la paume de la main. Frotter vivement les mains pour recouvrir de produit jusqu'a ce qu'elles soient seches.

  • INACTIVE INGREDIENT

    Inactive Ingredients / Ingrédients Inactifs : water, glycerin, propylene glycol, ispropyl myristate, aloe barbadensis leaf juice, tocopheryl acetate (Vitamin E), isopropyl alcohol, carbomer, triisopropanolamine. / Eau, glycérine, propylèneglycol, myristate isopropylique, jus de feuille d'aloès barbadine, acétate tocophérylique (Vitamine E), alcool isopropylique, carbomère, triisopropanolamine.

  • PRINCIPAL DISPLAY PANEL

    label

    label

  • INGREDIENTS AND APPEARANCE
    GEL INSTANT HAND SANITIZER 
    alcohol soap
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50865-370
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL0.07 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    ISOPROPYL ALCOHOL (UNII: ND2M416302)  
    .ALPHA.-TOCOPHEROL ACETATE, D- (UNII: A7E6112E4N)  
    TRIISOPROPANOLAMINE (UNII: W9EN9DLM98)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  
    WATER (UNII: 059QF0KO0R)  
    CARBOXYPOLYMETHYLENE (UNII: 0A5MM307FC)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:50865-370-271000 mL in 1 BAG; Type 0: Not a Combination Product09/15/2017
    2NDC:50865-370-361000 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product09/15/2017
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A09/15/2017
    Labeler - Kutol Products (004236139)
    Establishment
    NameAddressID/FEIBusiness Operations
    Kutol Products004236139manufacture(50865-370)