HAND SANITIZER (ETHYL ALCOHOL) GEL [ORAZEN INC]

HAND SANITIZER (ETHYL ALCOHOL) GEL [ORAZEN INC]
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NDC 71927-004-01
Set ID 7ba7442e-4079-0e80-e053-2a91aa0ae87c
Category HUMAN OTC DRUG LABEL
Packager Orazen Inc
Generic Name
Product Class
Product Number
Application Number PART333E
  • ACTIVE INGREDIENT

    Active ingredient:
    Ethyl alcohol 70%

  • PURPOSE

    Purpose

    Antiseptic

  • WARNINGS

    Warnings

    For external use only: hands

    Flammable. Keep away from heat and flame.

  • STOP USE

    Stop use and ask a doctor if

    • irritation or redness develops
    • condition persists for more that 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(1-800-222-1222) right away.

  • DOSAGE & ADMINISTRATION

    Directions

    • wet hands thoroughly with product and allow to dry without wiping
    • for children under 6, ues only under adult supervision
    • not recommended for infants

  • INACTIVE INGREDIENT

    Inactive ingredients

    acrylates/C10-C30 alkyl acrylate crosspolymer, aloe barbadensis leaf juice, aminomethyl propanol, glycerin, maltodextrin, propylene glycol, water

  • OTHER SAFETY INFORMATION

    Other Information

    • do not store above 105F
    • may discolor some fabrics
    • harmful to wood finishes and plastics

  • INDICATIONS & USAGE

    Uses to decrease bacteria on the skin that could cause disease. recommended for repeated use

  • WHEN USING

    When using this product

    • keep out of eyes. In case of contact with eyes, flush thoroughly with water.
    • avoid contact with broken skin
    • do not inhale or ingest
  • PRINCIPAL DISPLAY PANEL

    image of bottle label

  • INGREDIENTS AND APPEARANCE
    HAND SANITIZER 
    ethyl alcohol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71927-004
    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
    MALTODEXTRIN (UNII: 7CVR7L4A2D)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    WATER (UNII: 059QF0KO0R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    CARBOMER COPOLYMER TYPE A (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 71DD5V995L)  
    AMINOMETHYL PROPANEDIOL (UNII: CZ7BU4QZJZ)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:71927-004-0159 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product11/27/2018
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E11/27/2018
    Labeler - Orazen Inc (080916640)

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