Label: HAND SANITIZER- ethanol liquid

  • NDC Code(s): 69674-100-01, 69674-100-04, 69674-100-07
  • Packager: Saraya Healthcare
  • 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 January 2, 2019

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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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