Label: 3E CLEAN HAND SANITIZER- alcohol liquid

  • Category: HUMAN OTC DRUG LABEL

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 June 19, 2020

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  • DRUG FACTS

  • ACTIVE INGREDIENT

    Ethyl Alcohol 70% v/v

    Purpose

    Antimicrobial

  • USE(s)

    Hand Sanitizer to help reduce bacteria that potentially can cause disease  For usewhen soap and water are not available.

  • WARNING

    For external use only. Flammable.Keep away from heat of flame.

    DO NOT Use

    * in children less than 3 years of age* on open skin wounds

    When using this product,

    keep out of eyes,ears and mouth. In case of contact with eyes, rinse eyes throughly with water.

    Stop use and ask a doctor

    if irritation or rash occurs.These may be signs of a serious condition.

    Keep out of reach of children.

    If swallowed, get medical help or contact a Poison Control Center right away.

  • DIRECTIONS

    Place enough product on hands to cover all surfaces. Rub hands together until dry. Supervise children under 6 years of age when using this product to avoid swallowing.

  • INACTIVE INGREDIENTS

    Water (Aqua),Glycerin, Carbomer,Parfum, Dmdm Hydantoin, Triethanolamine,Butylphenyl Methylpropional, Coumarin,Benzyl salicylate, Benzyl Alcohol, Linalool.

  • OTHER INFORMATION

    * Store between 5-25C (41-77F) Avoid freezing and excessive heat above 40C (104F).

  • Package Labeling

    Label1

  • INGREDIENTS AND APPEARANCE
    3E CLEAN HAND SANITIZER 
    alcohol liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:78896-001
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL0.7 mL  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)  
    DMDM HYDANTOIN (UNII: BYR0546TOW)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    BUTYLPHENYL METHYLPROPIONAL (UNII: T7540GJV69)  
    COUMARIN (UNII: A4VZ22K1WT)  
    BENZYL SALICYLATE (UNII: WAO5MNK9TU)  
    BENZYL ALCOHOL (UNII: LKG8494WBH)  
    LINALOOL, (+/-)- (UNII: D81QY6I88E)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:78896-001-01250 mL in 1 BOTTLE; Type 0: Not a Combination Product06/20/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E06/20/2020
    Labeler - Erenay Kozmetik Gida Insaat Turizm Tekstil Tasimacilik Sanayi LTD. STI. (533147719)
    Establishment
    NameAddressID/FEIBusiness Operations
    Erenay Kozmetik Gida Insaat Turizm Tekstil Tasimacilik Sanayi LTD. STI.533147719manufacture(78896-001) , label(78896-001) , pack(78896-001) , relabel(78896-001) , repack(78896-001) , transfill(78896-001)
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