Label: WET WIPES SANITIZER- alcohol swab

  • 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 August 11, 2020

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  • PURPOSE

    Antibacterial

  • WARNINGS

    For external use only.Keep out of the eyes. In case of eye contact, rinse with water.If irritation develps discontinue use and consult a doctor if irritation persists more than 72 hours. If swallowed, seek medical attention or contact a Poison Control Center.

  • INACTIVE INGREDIENT

    Alcohol Denat (Ethanol) ,Glycerin, Melaleuca Alternifolia Leaf Extract, Hypericum Perforatum Extract, Chlorhexidine Gluconate , Aqua

  • ACTIVE INGREDIENT

    % 80 Alcohol Denat (Ethanol)

  • INDICATIONS & USAGE

    ecreases bacteria on skin. recommended for repeated use

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of the reach of children, except with adult supervision.

  • DOSAGE & ADMINISTRATION

    ake wipe and rub thoroughly over all surfaces of both hands.Rrub hands together briskly to dry·dispose of wipe. For children under 2 years ask a doctor before use.

  • PRINCIPAL DISPLAY PANEL

    creamolingredient

  • INGREDIENTS AND APPEARANCE
    WET WIPES SANITIZER 
    alcohol swab
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:77892-0004
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL80 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    MELALEUCA ALTERNIFOLIA LEAF (UNII: G43C57162K)  
    HYPERICUM PERFORATUM LEAF (UNII: DOC7OB843Y)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:77892-0004-12 g in 1 POUCH; Type 0: Not a Combination Product08/31/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A08/31/2020
    Labeler - LABER KIMYA AR-GE SANAYI TICARET - LEVENT KAHRIMAN (502952094)
    Establishment
    NameAddressID/FEIBusiness Operations
    LABER KIMYA AR-GE SANAYI TICARET - LEVENT KAHRIMAN502952094manufacture(77892-0004)
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