Label: PROSERA HAND SANITIZER- ethyl alcohol spray

  • Contains inactivated NDC Code(s)
    NDC Code(s):     75306-008-01, 75306-008-02, 75306-008-03, 75306-008-04, view more
    75306-008-05, 75306-008-06, 75306-008-07, 75306-008-08, 75306-008-09, 75306-008-10, 75306-008-11, 75306-008-12, 75306-008-13, 75306-008-14, 75306-008-15, 75306-008-16, 75306-008-17
  • Packager: D-Time Limited Liability Company
  • 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 November 2, 2021

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  • Active Ingredient

    Ethyl alcohol 80%

  • Purpose

    Antiseptic skin cleanser

  • Uses

     For personal hand hygiene to help prevent the spread of bacteria

  • Warnings

    For external use only

    When using this product avoid contact with eyes. If contact occurs, rinse thoroughly with water.

    Stop use and consult a healthcare professional if irritation develops.

    Flammable. Keep away from open flame and sources of heat

  • Keep out of reach of children.

     If swallowed, contact a Poison Control Center or , get medical help right away.

  • Directions

    • Adults and children over 2 years: ∙ 
    • For occasional and personal domestic use ∙ 
    • Supervise children when they use this product ∙
    •  Rub thoroughly into hands for at least 30 seconds. Allow to dry.
  • Inactive ingredients

    Aqua, Glycerin, Vitamin E, Sage Oil, Hydrogen peroxide, Sodium pyruvate

  • Other Information

    Store at 68° to 70° F (20° to 25° C). May discolor certain fabrics or surfaces.

  • Label

    Label

  • INGREDIENTS AND APPEARANCE
    PROSERA HAND SANITIZER 
    ethyl alcohol spray
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:75306-008
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL80 mL  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    .ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)  
    SAGE OIL (UNII: U27K0H1H2O)  
    HYDROGEN PEROXIDE (UNII: BBX060AN9V)  
    SODIUM PYRUVATE (UNII: POD38AIF08)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:75306-008-0130 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product06/01/2020
    2NDC:75306-008-0250 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product06/01/2020
    3NDC:75306-008-0360 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product06/01/2020
    4NDC:75306-008-04100 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product06/01/2020
    5NDC:75306-008-05120 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product06/01/2020
    6NDC:75306-008-06150 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product06/01/2020
    7NDC:75306-008-07160 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product06/01/2020
    8NDC:75306-008-08200 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product06/01/2020
    9NDC:75306-008-09250 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product06/01/2020
    10NDC:75306-008-10500 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product06/01/2020
    11NDC:75306-008-111000 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product06/01/2020
    12NDC:75306-008-123785 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product06/01/2020
    13NDC:75306-008-1318927 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product06/01/2020
    14NDC:75306-008-145000 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product06/01/2020
    15NDC:75306-008-1510000 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product06/01/2020
    16NDC:75306-008-1615000 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product06/01/2020
    17NDC:75306-008-1720000 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product06/01/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A06/01/2020
    Labeler - D-Time Limited Liability Company (081728006)
    Establishment
    NameAddressID/FEIBusiness Operations
    D-Time Limited Liability Company081728006manufacture(75306-008)
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