EZFOAM FOAMING ALCOHOL HAND SANITIZER (FOAMING HAND SANITIZER) SOLUTION [RJ SCHINNER]

EZFOAM FOAMING ALCOHOL HAND SANITIZER (FOAMING HAND SANITIZER) SOLUTION [RJ SCHINNER]
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NDC 71303-001-01, 71303-001-02, 71303-001-04, 71303-001-05, 71303-001-06, 71303-001-07, 71303-001-08, 71303-001-09
Set ID 4998922d-258e-6fb4-e054-00144ff8d46c
Category HUMAN OTC DRUG LABEL
Packager RJ Schinner
Generic Name
Product Class
Product Number
Application Number PART333A
  • ACTIVE INGREDIENT

    Ethyl Alcohol 62% v/v.......Antibacterial Agent

  • INACTIVE INGREDIENT

    Water, AMP-C8-18 Perfluoroalkylethyl Phosphate, Glycerin.

  • PURPOSE

    Hand Sanitizer to help reduce bacteria on the skin that could cause disease. Recommended for repeated use.

  • WARNINGS

    For external use only.

    FLAMMABLE. Keep away from heat or flames.

    Avoid contact with eyes. If eye contact occurs, flush with water.

    Stop use if, in rare instances, redness or irritation develop. If condition persists for more than 72 hours, consult a physician.

    Keep out of reach of children. If swallowed, contact a physician or poison control center.

  • DOSAGE & ADMINISTRATION

    To decrease bacteria on skin, apply small amount to palm. Briskly rub, covering hands with product until dry.

  • INDICATIONS & USAGE

    Hand sanitizer to help reduce bacteria on the skin that could cause disease. Recommended for repeated use.

    Avoid contact with eyes. If eye contact occurs, flush with water.

    Stop use if, in rare instances, redness or irritation develop. If condition persists for more than 72 hours, consult a physician.

    Keep out of reach of children. If swallowed, contact a physician or poison control center.

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children. If swallowed, contact a physician or poison control center.

  • PRINCIPAL DISPLAY PANEL

    LABEL

  • INGREDIENTS AND APPEARANCE
    EZFOAM FOAMING ALCOHOL HAND SANITIZER 
    foaming hand sanitizer solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71303-001
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL62 mL  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    AMINOMETHYLPROPANOL (PERFLUORO-C6-C12 ETHYL)PHOSPHATE (UNII: QCD5R22RNT)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:71303-001-01213125 mL in 1 DRUM; Type 0: Not a Combination Product03/10/2017
    2NDC:71303-001-023785 mL in 1 JUG; Type 0: Not a Combination Product03/10/2017
    3NDC:71303-001-0450 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product03/10/2017
    4NDC:71303-001-051000 mL in 1 BAG; Type 0: Not a Combination Product03/10/2017
    5NDC:71303-001-061000 mL in 1 BAG; Type 0: Not a Combination Product03/10/2017
    6NDC:71303-001-07950 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product03/10/2017
    7NDC:71303-001-08532 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product03/10/2017
    8NDC:71303-001-091200 mL in 1 BAG; Type 0: Not a Combination Product03/10/2017
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A03/10/2017
    Labeler - RJ Schinner (023432909)
    Registrant - Kutol Products Company, Inc. (004236139)
    Establishment
    NameAddressID/FEIBusiness Operations
    Kutol Products Company, Inc.004236139manufacture(71303-001) , analysis(71303-001) , label(71303-001) , pack(71303-001)

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