Label: INSTAFRESH- alcohol liquid

  • 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 April 29, 2011

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  • ACTIVE INGREDIENT

    Active Ingredients

    Ethyl Alcohol 70% (v/v)

  • PURPOSE

    Purpose

    Hand Sanitizer

  • INDICATIONS & USAGE

    Uses

    Helps reduce potentially harmful pathogens from hands

    Helps prevent cross contamination by hand contact

    Helps prevent drying and chafing of skin

    Recommended for repeated use

  • WARNINGS

    Warnings

    For External use only

    Flammable, keep away from fire or flame

    When using this product

    Do not use in or near the eyes

    Avoid contact with broken skin

    Use in well-ventilated area

    Discontinue use if irritation and/or redness develops

    Keep out of reach of children.

    In case of accidental ingestion, seek medical attention or contact Poison Control Center immediately

  • DOSAGE & ADMINISTRATION

    Directions

    Wet hands thoroughly with product, covering entire surface of hands, including fingertips, cuticles, wrists and forearms

    Rub vigorously into skin until dry

    No rinsing or toweling required


  • STORAGE AND HANDLING

    Other Information

    Store in a cool dry place below 104 F

  • INACTIVE INGREDIENT

    Inactive ingredients

    Acrylates/C10-30 Alkyl Acrylate Crosspolymer, EDTA, Glycerin. Tetrahydroxypropyl Ethylenediamine and Water

  • QUESTIONS

    Questions or Comments

    For product or technical information contact Sultan Chemists Inc. at 201-871-1232, toll free 1-800-637-8582 or visit our website at www.sultanchemists.com

  • PRINCIPAL DISPLAY PANEL

    InstaFresh

    Instant Hand Sanitizer

    70% Ethanol Formulation provides effective decontamination

    Moisturizers leave hands feeling soft and clean

    Dries quickly without sticky residue

    Low viscosity allows for easier, faster coverage

    Complies with CDC Hand Hygiene Recommendations

    Ideal for use in the Touch Less Sanitizer Dispenser

    REF 95708

    CONTENTS: 1 Gallon (3.8L)

    container label

  • INGREDIENTS AND APPEARANCE
    INSTAFRESH 
    alcohol liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0699-0957
    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
    CARBOMER INTERPOLYMER TYPE A (55000 MPA.S)) (UNII: 59TL3WG5CO)  
    EDETIC ACID (UNII: 9G34HU7RV0)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    WATER (UNII: 059QF0KO0R)  
    EDETOL (UNII: Q4R969U9FR)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0699-0957-04118 mL in 1 BOTTLE, PLASTIC
    2NDC:0699-0957-08532 mL in 1 BOTTLE, PLASTIC
    3NDC:0699-0957-02946 mL in 1 BOTTLE, PLASTIC
    4NDC:0699-0957-013785 mL in 1 BOTTLE, PLASTIC
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A09/01/2005
    Labeler - DSHealthcare (056296981)
    Establishment
    NameAddressID/FEIBusiness Operations
    Central Solutions Inc007118524manufacture
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