Label: OPS 70 PERCENT ALCOHOL FOAMING SKIN SANITIZER- ethyl alcohol solution

  • NDC Code(s): 79016-101-12
  • Packager: Archer Manufacturing, 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 September 23, 2023

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  • ACTIVE INGREDIENTS

    ETHYL ALCOHOL 68-72% V/V

  • PURPOSE

    ANTIMICROBIAL

  • USES

    • FOR HAND SANITIZING TO DECREASE BACTERIA ON THE SKIN.
    • RECOMMENDED FOR REPEATED USE.
  • WARNINGS

    FLAMMABLE. KEEP AWAY FROM FIRE AND FLAMES.

    FOR EXTERNAL USE ONLY.

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

    STOP USE AND ASK A DOCTOR IF IRRITATION OR REDNESS DEVELOPS, OR IF CONDITION PERSISTS FOR MORE THAN 72 HOURS.

  • KEEP OUT OF REACH OF CHILDREN

    KEEP EXPOSED CARTRIDGE OUT OF REACH OF CHILDREN. IF SWALLOWED, GET MEDICAL HELP OR CONTACT POISON CONTROL RIGHT AWAY.

  • DIRECTIONS

    • PUMP A SMALL AMOUNT OF FOAM INTO PALM OF HAND
    • RUB HANDS TOGETHER BRISKLY UNTIL DRY.
  • INACTIVE INGREDIENTS

    WATER, FOAMING SURFACTANT (PROPRIETARY), GLYCERIN.

  • PRINCIPAL DISPLAY PANEL

    01b LBL_OPS 70percent-Dec 21

  • INGREDIENTS AND APPEARANCE
    OPS 70 PERCENT ALCOHOL FOAMING SKIN SANITIZER 
    ethyl alcohol solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:79016-101
    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
    GLYCERIN (UNII: PDC6A3C0OX)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:79016-101-121000 mL in 1 POUCH; Type 0: Not a Combination Product11/08/2021
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A11/08/2021
    Labeler - Archer Manufacturing, Inc. (144669251)
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