Label: AERIUM HAND SANITIZER 70% 100ML- ethyl 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 May 25, 2020

If you are a consumer or patient please visit this version.

  • Active Ingredient(s)

    Ethyl Alcohol 70% v/v. Purpose: Antiseptic

    active ingredient

  • Purpose

    Antiseptic, Hand Sanitizer

    purpose

  • Use

    Helath care personnel hand rub to help reduce bacteria that potentially can cause disease.

    use

  • Warnings

    For external use only. Flammable. Keep away from heat or flame

    warnings

  • Do not use

    • in children less than 2 months of age
    • on open skin wounds
    • do not use
  • When using

    When using this product keep out of eyes, ears, and mouth. In case of contact with eyes, rinse eyes thoroughly with water.

    When using

  • Stop use

    Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition.

    Stop use

  • Keep out

    Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.
    Keep out

  • Directions

    • Place enough product on hands to cover all surfaces. Rub hands together until dry.
    • Supervise children under 6 years of age when using this product to avoid swallowing.
    • directions
  • Other information

    • Store between 15-30C (59-86F)
    • Avoid freezing and excessive heat above 40C (104F)
    • other information
  • Inactive ingredients

    Water, Glycerin, Carbomer, Aminomethyl Propanol, Mentha Arvensis Leaf Oil, Tocopheryl Acetate, Panthenol, Sodium Hyaluronate, Aloe Barbadensis Leaf Extract

    Inactive ingredient

  • Questions or comments?

    1-800-819-4159

    Questions

  • Package Label - Principal Display Panel

    Aerium Hand Sanitizer
    Helps reduce bacteria and germs

    Contains Recommended 70% Alcohol Content
    Moisturizes with Aloe Formula
    Sanitizes to Help Reduce the Spread of Germs

    Ethyl Alcohol 70%

    100ml / 3.38 fl.oz

    PDP

  • INGREDIENTS AND APPEARANCE
    AERIUM HAND SANITIZER 70% 100ML 
    ethyl alcohol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:74924-103
    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
    WATER (UNII: 059QF0KO0R)  
    CARBOMER 940 (UNII: 4Q93RCW27E)  
    AMINOMETHYLPROPANOL (UNII: LU49E6626Q)  
    MENTHA ARVENSIS LEAF OIL (UNII: 1AEY1M553N)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    PANTHENOL (UNII: WV9CM0O67Z)  
    HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:74924-103-0360 in 1 CARTON03/30/2020
    1NDC:74924-103-026 in 1 PACKAGE
    1NDC:74924-103-01100 mL in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A03/30/2020
    Labeler - SM Global, LLC. (834972353)
    Registrant - E.CIS COSMETIC.Co.,Ltd (689846270)
    Establishment
    NameAddressID/FEIBusiness Operations
    E.CIS COSMETIC.Co.,Ltd689846270manufacture(74924-103)