Label: SPRINJENE- alcohol gel

  • 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 July 22, 2020

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  • SPL UNCLASSIFIED SECTION

    DRUG FACTS

  • ACTIVE INGREDIENT

    ETHYL ALCOHOL (70%)

  • PURPOSE

    ANTIMICROBIAL

  • USES

    • HAND SANITIZER TO HELP REDUCE BACTERIA ON THE SKIN THAT COULD CAUSE DISEASE
    • RECOMMENDED FOR REPEATED USE
  • WARNINGS

    FLAMMABLE. KEEP AWAY FROM FIRE OR FLAME

    FOR EXTERNAL USE ONLY

    WHEN USING THIS PRODUCT DO NOT USE IN OR NEAR THE EYES. IN CASE OF CONTACT, RINSE EYES THOROUGHLY WITH WATER.

    STOP USE AND ASK A DOCTOR IF IRRITATION OR RASH APPEARS AND LASTS

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

  • DIRECTIONS

    • PLACE ENOUGH PRODUCT IN YOUR PALM TO THOROUGHLY COVER YOUR HANDS
    • RUB HANDS TOGETHER BRISKLY UNTIL DRY
    • NO RINSING REQUIRED
    • NO TOWELS NEEDED
  • OTHER INFORMATION

    • DO NOT STORE ABOVE 110°F (43°C)
    • MAY DISCOLOR CERTAIN FABRICS OR SURFACES
  • INACTIVE INGREDIENTS

    AQUA (WATER), GLYCERIN, ACRYLATES/C10-30 ALKYL ACRYLATE CROSSPOLYMER, TRIETHYLENEAMINE (TEA), TOCOPHERYLACETATE (VITAMIN E), NIGELLA SATIVA (BLACK SEED OIL)

  • QUESTIONS OR COMMENTS?

    CALL 1-844-346-2872 MONDAY THROUGH FRIDAY 8:00 AM TO 5:00 PM

  • PRINCIPAL DISPLAY PANEL - 80 mL Bottle Label

    SprinJene®

    HAND
    SANITIZER

    KILLS 99.99% OF GERMS
    70% ALCOHOL

    Advanced Antimicrobial Formula with
    BLACK SEED OIL (Nigella Sativa)

    MOISTURIZING GEL

    NOURISHES DRY SKIN

    LEAVES HANDS FEELING SOFT

    Vitamin E

    NET WT 2.7 oz. (80 mL)

    PRINCIPAL DISPLAY PANEL - 80 mL Bottle Label
  • INGREDIENTS AND APPEARANCE
    SPRINJENE 
    alcohol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63404-0720
    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)  
    Carbomer Interpolymer Type A (Allyl Sucrose Crosslinked) (UNII: 59TL3WG5CO)  
    TRIETHYLENE AMINE (UNII: VG267KM5GH)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:63404-0720-1500 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product08/01/2020
    2NDC:63404-0720-2300 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product08/01/2020
    3NDC:63404-0720-3250 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product08/01/2020
    4NDC:63404-0720-480 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product08/01/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH NOT FINALpart333E08/01/2020
    Labeler - Health and Natural Beauty USA Corp (079129688)
    Establishment
    NameAddressID/FEIBusiness Operations
    Health and Natural Beauty USA Corp079129688MANUFACTURE(63404-0720)
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