Label: CLEAN N FRESH INSTANT HAND SANITIZER ANTIBACTERIAL- alcohol gel

  • 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 2, 2020

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  • Active Ingredient

    Ethyl Alcohol 62% v/v

  • Purpose

    Antiseptic

  • Uses

    *To sanitize hands without requiring water or a rinse*Kills 99.9% of most common bacteria in 15 seconds.

  • Warnings

    FLAMMABLE

    For external use only

  • When using this product

    *Do not use near heat or flame do not use in or near eyes * Discontinue use if irritation and redness develop * Do not use on deep or puncture wounds, consult your doctor.

  • Keep out of reach of children.

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

  • Directions

    *Apply gel liberally to unsoiled hands and rub in thoroughly * Allow to dry without wiping or rinsing.

  • Other information

    Store at room temperature.

  • Inactive Ingredients:

    Water, Carbomer, Glycerin, Diisopropylamine, Iso propyl Myristate

  • Product label

    CNF 800 ml

  • INGREDIENTS AND APPEARANCE
    CLEAN N FRESH INSTANT HAND SANITIZER ANTIBACTERIAL 
    alcohol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:73708-514
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL147 mL  in 236 mL
    Inactive Ingredients
    Ingredient NameStrength
    CARBOMER INTERPOLYMER TYPE A (55000 CPS) (UNII: 59TL3WG5CO) 0.75 mL  in 236 mL
    DIISOPROPYLAMINE (UNII: BR9JLI40NO) 0.39 mL  in 236 mL
    WATER (UNII: 059QF0KO0R) 87.17 mL  in 236 mL
    GLYCERIN (UNII: PDC6A3C0OX) 0.45 mL  in 236 mL
    ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS) 0.23 mL  in 236 mL
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:73708-514-17800 mL in 1 BAG; Type 0: Not a Combination Product10/01/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A10/01/2020
    Labeler - CarrollCLEAN LLC (081222623)
    Establishment
    NameAddressID/FEIBusiness Operations
    CarrollCLEAN LLC081222623manufacture(73708-514)
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