HAND SANITIZER (ETHANOL) LIQUID [SARAYA HEALTHCARE]

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HAND SANITIZER (ETHANOL) LIQUID [SARAYA HEALTHCARE]
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NDC 69674-100-01, 69674-100-04, 69674-100-07
Set ID 30c68860-c7ff-5dbb-e054-00144ff8d46c
Category HUMAN OTC DRUG LABEL
Packager Saraya Healthcare
Generic Name
Product Class
Product Number
Application Number PART333E
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  • Drug Facts

  • ACTIVE INGREDIENT

    Active Ingredient

    Ethanol 62%

  • PURPOSE

    Purpose

    Hand Sanitizer

  • INDICATIONS & USAGE

    Uses

    • Sanitizes hands to help reduce bacteria that potentially can cause diseases
    • Helps to prevent cross-contamination
    • Helps to prevent drying of the skin
    • Recommended for repeated use
  • WARNINGS

    Warnings

    • For external use only
    • Flammable, keep away from fire or flame
  • WHEN USING

    When using this product

    • Do not use in or near eyes
    • Use in a well-ventilated area
    • Discontinue use if irritation and redness develop
  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children

    In case of accidental ingestion, seek medical attention or contact a poison control center immediately

  • DOSAGE & ADMINISTRATION

    Directions

    • Receive a small amount of foam into palm of hand
    • Rub thoroughly over all surfaces of both hands, especially fingernails and cuticles
    • Rub hands together until dry
  • STORAGE AND HANDLING

    Other information

    • Store in a cool, dry place below 104°F
  • INACTIVE INGREDIENT

    Inactive ingredients

    Water, DEA-C8-18 perfluoroalkylethyl phosphate, glycereth-2 cocoate, denatonium benzoate, tert-butyl alcohol

  • QUESTIONS

    Questions?

    Contact Saraya Healthcare USA Mon - Fri

    9am - 4pm PST at 866.822.1801

  • SPL UNCLASSIFIED SECTION

    Distributed by:

    Saraya Healthcare USA

    P.O. Box 1360

    Penn Valley, CA 95946

    866.822.1801

    sarayahealthcareusa.com

  • SARAYA Healthcare USA

    - Kills 99.999% of 26 tested pathogens in 15 seconds

    - Formulated with emollients to help keep hands soft

    - 62% Ethanol formula

    Hand Sanitizer Foam

    Net Contents: 1250mL (42 fl oz)

    Saraya Alc Hand Sanitizer Foam

  • INGREDIENTS AND APPEARANCE
    HAND SANITIZER 
    ethanol liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69674-100
    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
    DIETHANOLAMINE BIS(C8-C18 PERFLUOROALKYLETHYL)PHOSPHATE (UNII: 4J55VM509S)  
    TERT-BUTYL ALCOHOL (UNII: MD83SFE959)  
    WATER (UNII: 059QF0KO0R)  
    GLYCERETH-2 COCOATE (UNII: JWM00VS7HC)  
    DENATONIUM BENZOATE (UNII: 4YK5Z54AT2)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69674-100-01500 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product04/14/2016
    2NDC:69674-100-041250 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product04/14/2016
    3NDC:69674-100-0745 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product04/14/2016
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E04/14/2016
    Labeler - Saraya Healthcare (079729980)
    Establishment
    NameAddressID/FEIBusiness Operations
    Best Sanitizers627278224manufacture(69674-100)
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