Label: AZURO- 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 January 4, 2010

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  • ACTIVE INGREDIENT

    Active ingredient Purpose

    70% V/V Ethyl alcohol.....Antiseptic

  • INDICATIONS & USAGE

    Uses

    for handwashing to decrease bacteria on the skin

    recommended for repeated use

  • WARNINGS

    Warnings

    For external use only.

    Flammable, keep away from fire or flame.

  • DO NOT USE

    Do not use in the eyes.  In case of

    contact, rinse eyes thoroughly

    with water.

  • STOP USE

    Discontinue use if irritation and

    redness develop.

  • ASK DOCTOR

    If condition persists

    for more than 72 hours, consult

    a doctor.

  • 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.

  • INDICATIONS & USAGE

    Directions

    wet hands thoroughly with product

    and allow to dry without wiping

    supervise children in the use of this product

  • GENERAL PRECAUTIONS

    Other Information

    avoid temperature over 110F

    may discolor certain fabrics

    harmful to wood finishes and plastics

  • INACTIVE INGREDIENT

    Inactive ingredients

    Water, Aloe vera, Carbomer, Tocopheryl acetate, Triethanolamine,

    Glycerin, Fragrance.

  • QUESTIONS

    Questions?

    call 1 866 377-3030

    weekdays, 9AM - 5PM EST

  • SPL UNCLASSIFIED SECTION

    Enter section text here

  • PRINCIPAL DISPLAY PANEL

    1L Bottle Label

    ANTISEPTIC HAND SANITIZER

    AZURO

    ORIGINAL

    SCENTED GEL

    KILLS 99.9% OF COMMON BACTERIA OR GERMS!

    70% V/V Ethyl Alcohol

    formula enriched with

    Vitamin E and Aloe vera.

    Simple and convenient,

    Azuro sanitizes without

    the use of water.

    Emollients leave hands

    feeling soft and smooth

    even during prolonged use.

       fl oz. (  L/mL)

  • INGREDIENTS AND APPEARANCE
    AZURO  
    alcohol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49955-100
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL0.7 L  in 1 L
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    .ALPHA.-TOCOPHEROL ACETATE, D- (UNII: A7E6112E4N)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:49955-100-101 L in 1 BOTTLE
    2NDC:49955-100-131.3 L in 1 BOTTLE
    3NDC:49955-100-500.5 L in 1 BOTTLE
    4NDC:49955-100-250.25 L in 1 BOTTLE
    5NDC:49955-100-600.06 L in 1 BOTTLE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart33311/18/2009
    Labeler - Noveko Inc (205614519)
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