Label: SCIGEN HAND SANITIZER- alcohol spray

  • 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 November 23, 2020

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  • Drug Facts

  • ACTIVE INGREDIENT

    Active Ingredients:

    Organic Ethanol 65%  v/v

  • PURPOSE

    Purpose:

    Antiseptic

  • INDICATIONS & USAGE

    Uses: • Hand sanitizer to help reduce viruses and bacteria that potentially can cause disease • Recommended for repeated use 

  • WARNINGS

    Warnings:

    • Flammable, keep away from fire or flame.
    • For external use only
    • Do not use in eyes. If contact occurs, flush thoroughly with water.
    • Stop use and ask a doctor if redness and irritation develop and persists for more than 72 hours.

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

  • DOSAGE & ADMINISTRATION

    Directions: • Place enough product on hands to cover all surfaces. Rub hands together until dry • Do not use other than directed.

  • STORAGE AND HANDLING

    Other Information: •  Store below 86° F

  • INACTIVE INGREDIENT

    Inactive Ingredients: Purified Water, Glycerin, Hydrogen Peroxide

  • SPL UNCLASSIFIED SECTION

    Unscented

    Scigen, Inc.

    Paramount, CA.

    info@scigenus.com

    Made in U.S.A.

  • Packaging

    untitled

  • INGREDIENTS AND APPEARANCE
    SCIGEN HAND SANITIZER 
    alcohol spray
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:74510-001
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL65 mL  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    HYDROGEN PEROXIDE (UNII: BBX060AN9V)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:74510-001-0212 in 1 BOX05/09/2020
    1NDC:74510-001-01110 mL in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A05/09/2020
    Labeler - Scigen, Inc (806606166)
    Registrant - Scigen Inc. (806606166)
    Establishment
    NameAddressID/FEIBusiness Operations
    Scigen, Inc806606166manufacture(74510-001)
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