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 6, 2020

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  • Active Ingredient(s)

    Alcohol 62% v/v. Purpose: Antimicrobial

  • Use

    Hand Sanitizer to help reduce bacteria on the skin

    CASE

  • Warnings

    Flammable, keep away from fire or flame. For external use only.

    When using this product Avoid contact with eyes, ears, mouth, entire body, or damaged skins.
    Stop use and ask a doctor If redness or irritation develop and persist.
    Keep out of reach of children If swallowed, get medical help or contact a Sanitizer Gel Poison Control center right away.

  • Directions

    • Spread on both hands, rub in, let dry.
  • Other information

    • Store at room temperature 34~86°F (1~30°C)
    • box
  • Inactive ingredients

    Water, Glycerin, Carbomer, Butylene Glycol, Phenoxyethanol, Arginine, Mugwort Extract, Yeast Extract, Luffa Extract, Fragrance

  • Keep out of reach of children

    Keep out of reach of children

  • Purpose

    Hand sanitizer to help reduce bacteria on the skin

  • Package Label - Principal Display Panel

    BOTTLE LABELCASE LABELBOX16.9 fl. oz. (500 mL) NDC: 74086-650-02

  • 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
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    YEAST, UNSPECIFIED (UNII: 3NY3SM6B8U)  
    ARGININE (UNII: 94ZLA3W45F)  
    CARBOMER 940 (UNII: 4Q93RCW27E)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    ARTEMISIA PRINCEPS LEAF (UNII: SY077EW02G)  
    WATER (UNII: 059QF0KO0R)  
    LUFFA (UNII: F0R3Y60C6V)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:74086-650-02500 mL in 1 BOTTLE, DISPENSING; Type 0: Not a Combination Product03/30/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A03/30/2020
    Labeler - Azer Scientific, Inc. (137459512)
    Registrant - Azer Scientific, Inc. (137459512)
    Establishment
    NameAddressID/FEIBusiness Operations
    Azer Scientific, Inc.137459512repack(74086-650) , relabel(74086-650)
    Establishment
    NameAddressID/FEIBusiness Operations
    Soleo Cosmetic Co., Ltd.557829412api manufacture(74086-650)
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