Label: ALCOHOL HAND SANITIZER- ethyl alcohol solution

  • NDC Code(s): 70415-107-11, 70415-107-12, 70415-107-21, 70415-107-22
  • Packager: CWGC LA Inc.
  • 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 January 3, 2022

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  • Active ingredient

    Ethyl Alcohol 70 %

  • PURPOSE

    ANTIBACTERIAL

  • Uses

    70% ALCOHOL HAND SANITIZERS KILL MOST BACTERIA, AND FUNGI AND STOP SOME VIRUSES, KILL 99.9% OF THE BACTERIA ON HANDS 30 SECONDS AFTER APPLICATION AND 99.99% TO 99.999% IN ONE MINUTE.

  • Warnings

    FOR EXTERNAL USE ONLY

    KEEP AWAY FROM FIRE OR FLAME

    WHEN USING THIS PRODUCT, AVOID CONTACT WITH EYES, IN CASE OF EYE CONTACT, FLUSH WITH WATER.

    When using this productavoid contact with eyes. In case of eye contact, flush with water

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

  • Directions

    APPLY AMOUNT OF SANITIZER IN YOUR PALM TO THOROUGHLY COVER YOUR HANDS, RUB HANDS TOGETHER BRISKLY UNTIL DRY, NO RINSING REQUIRED.

  • Inactive ingredients

    AQUA, GLYCERIN, PROPYLENE GLYCOL, CARBOMER, AMINOMETHYL PROPANOL

  • PRINCIPAL DISPLAY PANEL

    01b LBL_Sierra Soft Alcohol Hand Sanitizer_1000mL

    01b LBL_Sierra Soft Alcohol Hand Sanitizer_236mL

  • INGREDIENTS AND APPEARANCE
    ALCOHOL HAND SANITIZER 
    ethyl alcohol solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70415-107
    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)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)  
    AMINOMETHYLPROPANOL (UNII: LU49E6626Q)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70415-107-111000 mL in 1 BOTTLE; Type 0: Not a Combination Product04/14/2020
    2NDC:70415-107-12500 mL in 1 BOTTLE; Type 0: Not a Combination Product04/14/2020
    3NDC:70415-107-2159 mL in 1 TUBE; Type 0: Not a Combination Product06/26/2020
    4NDC:70415-107-22236 mL in 1 TUBE; Type 0: Not a Combination Product06/26/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A04/14/2020
    Labeler - CWGC LA Inc. (034967904)
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