Label: HAND SANITIZER 70 PERCENT- ethyl alcohol gel

  • Category: HUMAN OTC DRUG LABEL

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 29, 2022

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  • ACTIVE INGREDIENT

    ETHYL ALCOHOL 70%

  • PURPOSE

    ANTIMICROBIAL

  • USES

    • FOR HANDWASHING TO DECREASE MICROBIAL CONTAMINATION ON THE SKIN
    • MAY BE REAPPLIED DURING THE DAY AS REQUIRED
  • WARNINGS

    FOR EXTERNAL USE ONLY. DO NOT DRINK.

    FLAMMABLE, KEEP AWAY FROM FIRE AND FLAME.

    DO NOT USE IN THE EYES. IN CASE OF CONTACT, RINSE EYES THOROUGHLY WITH WATER, THEN CONTACT PHYSICIAN.

    STOP USE AND ASK A DOCTOR IF IRRITATION AND REDNESS DEVELOP AND PERSISTS FOR MORE THAN 72 HOURS

  • 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

    • WET HANDS THOROUGHLY WITH PRODUCT
    • BRISKLY RUB HANDS TOGETHER UNTIL DRY
    • SUPERVISE CHILDREN UNDER 6 YEARS IN THE USE OF PRODUCT
  • OTHER INFORMATION

    • STORE AT 20°C TO 25°C (68°F TO 77°F)
    • MAY DISCOLOR SOME FABRICS
  • INACTIVE INGREDIENTS

    PURIFIED WATER/AQUA/EAU PURIFIE, GLYCERIN, CELLULOSE

  • PRINCIPAL DISPLAY PANEL

    01b LBL_CSI_Hand Sanitizer_8oz_R2-3.75x5.5-final

  • INGREDIENTS AND APPEARANCE
    HAND SANITIZER   70 PERCENT
    ethyl alcohol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50518-306
    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)  
    POWDERED CELLULOSE (UNII: SMD1X3XO9M)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:50518-306-11240 mL in 1 BOTTLE; Type 0: Not a Combination Product05/25/2020
    2NDC:50518-306-12480 mL in 1 BOTTLE; Type 0: Not a Combination Product05/25/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A05/25/2020
    Labeler - CUSTOM RESEARCH LABS INC (028611598)
    Registrant - CUSTOM RESEARCH LABS INC (028611598)
    Establishment
    NameAddressID/FEIBusiness Operations
    CUSTOM RESEARCH LABS INC028611598manufacture(50518-306)
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