Label: AZER HAND SANITIZER- alcohol gel

  • 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 April 17, 2020

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  • Active Ingredient(s)

  • Purpose

    Antiseptic

  • Uses

    • to decrease bacteria on the skin that could cause disease
    • recommended for repeated use
  • Warning

    For external use only: hands

    Flammable, keep away from fire or flame

    When using this product, keep out of eyes. In case of contact with eyes, flush throughly with water. Avoid contact with broken skin. Do not inhale or ingest

  • Stop use and ask a doctor if

    • Irritation and redness develop
    • Condition persists for more than 72 hours
  • Keep out of reach of children

    If swallowed, get medical help or contact a Poison Control Center right away.

  • Directions

    • Wet hands thoroughly with product and allow to dry without wiping.
    • For children under 6, use only under adult supervision.
    • Not recommended for infants
  • Other Information

    • Do not store above 105°F
    • May discolor some fabrics
    • Harmful to wood finishes and plastics
  • Inactive ingredients


    • Purified water • Glycerin • Carbomer • Triethanolamine • Aloe Vera Oil
    • Aloe Vera gel • Tocopherol Acetate • Fragrance

  • Questions?

    1-877-770-2937

  • Package Label - Principal Display Panel

    Azer Hand

    Sanitizer Gel

    Alcohol Antiseptic 62%

    With Moisturizing

    Aloe Vera & Citrus Scent

    16 fl. oz. (473 mL) NDC: 74086-650-02

    BOTTLE LABEL

  • INGREDIENTS AND APPEARANCE
    AZER HAND SANITIZER 
    alcohol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:74086-650
    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
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    CARBOMER 940 (UNII: 4Q93RCW27E)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    WATER (UNII: 059QF0KO0R)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:74086-650-03473 mL in 1 BOTTLE, DISPENSING; Type 0: Not a Combination Product04/13/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A04/13/2020
    Labeler - Azer Scientific, Inc. (137459512)
    Registrant - Azer Scientific, Inc. (137459512)
    Establishment
    NameAddressID/FEIBusiness Operations
    Azer Scientific, Inc.137459512repack(74086-650) , relabel(74086-650)
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