Label: ALCOHOL HAND SANITIZER- ethyl alcohol solution

  • 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 March 8, 2021

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  • Active ingredient

    Ethyl Alcohol 70 %

  • PURPOSE

    ANTIBACTERIAL

  • Uses

    • FOR SANITIZING TO REDUCE BACTERIA ON THE SKIN.

  • Warnings

    FOR EXTERNAL USE ONLY

    FLAMMABLE : KEEP AWAY FROM FIRE OR FLAME

    WHEN USING THIS PRODUCT

    • AVOID CONTACT WITH EYES, IN CASE OF EYE CONTACT, FLUSH WITH WATER.

  • 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.

  • Directions

    • APPLY ONE SHOT OF FOAMING SANITIZER TO DRY HANDS
    • RUB INTO SKIN
    • NO RINSING REQUIRED
  • Inactive ingredients

    WATER, ISOPROPYL ALCOHOL, PROPYLENE GLYCOL, PEG-12 DIMETHICONE CROSSPOLYMER, BIS-PEG-12 DIMETHICONE

  • PRINCIPAL DISPLAY PANEL

    01b LBL_Delicare_Alcohol Hand Sanitizer_1000mL

  • INGREDIENTS AND APPEARANCE
    ALCOHOL HAND SANITIZER 
    ethyl alcohol solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:76591-103
    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)  
    ISOPROPYL ALCOHOL (UNII: ND2M416302)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    PEG-12 DIMETHICONE (300 CST) (UNII: ZEL54N6W95)  
    BIS-PEG-12 DIMETHICONE (70 MPA.S) (UNII: 2JDK5W22H4)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:76591-103-111000 mL in 1 BOTTLE; Type 0: Not a Combination Product12/21/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A12/21/2020
    Labeler - Guangzhou Gotdya Fine Chemical Co., Ltd. (551470189)
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