Label: AERIUM SANITIZER 75% 500ML- ethyl alcohol spray

  • 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 June 5, 2020

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  • Active Ingredient(s)

    Alcohol 80% v/v. Purpose: Antiseptic

    Active Ingredient(s)

  • Purpose

    Antiseptic, Hand Sanitizer

    Purpose

  • Use

    Hand Sanitizer to help reduce bacteria that potentially can cause disease. For use when soap and water are not available.

    Use

  • Warnings

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

    Warning

  • Do not use

    • in children less than 2 months of age
    • on open skin wounds

    Do not use

  • When using this product

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

    When using this product

  • Stop use and ask a doctor

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

    Stop use and ask 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.

    Keep out of reach of children

  • Directions

    • Spray 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, Fragrance(Parfum), PEG-40 Hydrogenated Castor Oil, PEG-60 Hydrogenated Castor Oil, Scutellaria Baicalensis Root Extract, Portulaca Oleracea Extract, Aloe Barbadensis Leaf Extract

    Inactive Ingredients

  • Package Label - Principal Display Panel

    Aerium
    Sanitizer Spray
    Helps reduce bacteria and germs

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

    500ml/ 16.9 fl.oz.

    Package Label - Principal Display Panel

  • INGREDIENTS AND APPEARANCE
    AERIUM SANITIZER 75% 500ML 
    ethyl alcohol spray
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:74924-110
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL75 mL  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    PEG-60 HYDROGENATED CASTOR OIL (UNII: 02NG325BQG)  
    SCUTELLARIA BAICALENSIS ROOT (UNII: 7J95K7ID2S)  
    PURSLANE (UNII: M6S840WXG5)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    POLYOXYL 40 HYDROGENATED CASTOR OIL (UNII: 7YC686GQ8F)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:74924-110-0224 in 1 CARTON06/05/2020
    1NDC:74924-110-01500 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 finalpart333A06/05/2020
    Labeler - SM Global, LLC. (834972353)
    Registrant - E.CIS COSMETIC.Co.,Ltd (689846270)
    Establishment
    NameAddressID/FEIBusiness Operations
    E.CIS COSMETIC.Co.,Ltd689846270manufacture(74924-110)
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