HAND SANITIZER (ETHYL ALCOHOL) GEL [ORAZEN INC]

HAND SANITIZER (ETHYL ALCOHOL) GEL [ORAZEN INC]
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NDC 71927-001-01
Set ID 600b618b-183a-18f6-e053-2a91aa0ae7ff
Category HUMAN OTC DRUG LABEL
Packager Orazen Inc
Generic Name
Product Class
Product Number
Application Number PART333E
  • ACTIVE INGREDIENT

    Active Ingredient:
    Ethyl Alcohol 62% w/w

  • PURPOSE

    Purpose

    Antiseptic

  • WARNINGS

    Warnings

    Flammable, keep away from fire or flame.

    For external use only.

  • STOP USE

    Stop use and ask a doctor if irritation and redness develops and 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 right away.

  • DOSAGE & ADMINISTRATION

    Directions

    • Wet hands thoroughly with product
    • Briskly rub hands together until dry
    • Supervise children in the use of this product

  • INACTIVE INGREDIENT

    Inactive Ingredients

    water, carbomer, fragrance, triethanoamine, glycerin, propylene glycol, isopropyl alcohol, isopropyl myristate, tocopheryl acetate, aloe vera extract

  • OTHER SAFETY INFORMATION

    Other Information

    • Store at room temperature 15 to 30C (59 to 86F)
    • May discolor certain fabrics

  • INDICATIONS & USAGE

    Use

    For hand washing to decrease bacteria on the skin

  • DO NOT USE

    Do not use in the eyes. In case of contact, rinse eyes thoroughly with water.

  • PRINCIPAL DISPLAY PANEL

    image of blister cardimage of bottle label

  • INGREDIENTS AND APPEARANCE
    HAND SANITIZER 
    ethyl alcohol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71927-001
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL62 mL  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    ISOPROPYL ALCOHOL (UNII: ND2M416302)  
    WATER (UNII: 059QF0KO0R)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    CARBOMER INTERPOLYMER TYPE A (55000 CPS) (UNII: 59TL3WG5CO)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:71927-001-0130 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product12/11/2017
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E12/11/2017
    Labeler - Orazen Inc (080916640)

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