Label: CAPIZONNE HAND SANITIZER- alcohol gel

  • Category: HUMAN OTC DRUG LABEL

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 31, 2020

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  • DRUG FACTS

  • Active ingredient

    Ethyl alcohol 70% v/v

    Purpose

    Antimicrobial

  • Use:

    Hand sanitizer to help reduce bacteria on the skin.

  • Warnings

    Flamable. Keep away from fire or flame. For external use only. Do not ingest, if swallowed seek medical help. Avoid contact with eyes.

    Keep out of reach of children.

    Children under 6yrs old to use under adult supervision. In case of irritation, discontinue use and consult your doctor.

  • Directions:

    Apply the Gel on the hands and rub gently for 20 seconds until the product evaporates.

  • Other information:

    Store below 106°F(41°C) May discolor certain fabrics or surfaces.

  • Inactive ingredients:

    demineralized water, glycerin, carbomer, triethanolamine, dmdm hydantoin, aloe barbadensis extract, iodopropynyl butylcarbamate, butylene glycol.

  • Package Labeling:

    Label

  • INGREDIENTS AND APPEARANCE
    CAPIZONNE HAND SANITIZER 
    alcohol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:80023-000
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL0.7 mL  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    DMDM HYDANTOIN (UNII: BYR0546TOW)  
    IODOPROPYNYL BUTYLCARBAMATE (UNII: 603P14DHEB)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:80023-000-01250 mL in 1 POUCH; Type 0: Not a Combination Product07/13/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E07/13/2020
    Labeler - Food Insixsigma, S.A. de C.V. (812834608)
    Establishment
    NameAddressID/FEIBusiness Operations
    Food Insixsigma, S.A. de C.V.812834608manufacture(80023-000) , label(80023-000) , pack(80023-000)
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