Label: B-GOOD HAND AND SKIN DISINFECTING AGENT- alcohol solution

  • 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 July 3, 2020

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  • DESCRIPTION

    B-GOOD HAND AND SKIN DISINFECTING AGENT (ANTISEPTIC SOLUTION)

  • Active Ingredient(s)

    Clorhexidine Digluconate 4%, Ethanol 10%

  • Purpose

    Antiseptic, Hand Sanitizer

  • Use

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

  • Warnings

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

  • Do not use

    • in children less than 2 months of age
    • on open skin wounds
  • WHEN USING

    When using this product keep out of eyes, ears, and mouth. In case of contact with eyes, rinse eyes thoroughly with water.

  • STOP USE

    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

    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.
  • Other information

    • Store between 15-30C (59-86F)
    • Avoid freezing and excessive heat above 40C (104F)
  • Inactive ingredients

    Glycerine, Preservative, Deionized water

  • Package Label - Principal Display Panel

    Producer

    HONNES SAGLIK VE ENDUSTRIYEL URUNLERI A.S.

    Cumhuriyet Mh. Karayel Sk. No:14 41420

    Cayirova/KOCAELI/TURKEY

    Tel.: +90 262 658 89 59

    Fax: +90 262 658 80 40

    www.honnes.com / info@honnes.com

    T.C. SAGLIK BAKANLIGI'NIN 09.08.2019 Tarihi ve 2019/97 No'lu Izniyle Uretilmistir.

    LICENSE HOLDER: HONNES SAGLIK VE ENDUSTRIYEL URUNLERI A.S.

    LICENCE DATE AND NUMBER 09.08.2019-2019/97

    ATTENTION, CAN BE USED EXTERNALLY, DO NOT DRINK

    Use the unpacked product within 6 months. The shelf life of the product is 2 years with its mouth closed, in a cool and dry place.

    SOLUTION

  • INGREDIENTS AND APPEARANCE
    B-GOOD HAND AND SKIN DISINFECTING AGENT 
    alcohol solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:79129-003
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CHLORHEXIDINE GLUCONATE (UNII: MOR84MUD8E) (CHLORHEXIDINE - UNII:R4KO0DY52L) CHLORHEXIDINE GLUCONATE4 mg  in 100 mL
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL10 mL  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    WATER (UNII: 059QF0KO0R)  
    Product Characteristics
    Color    Score    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:79129-003-01100 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product03/30/2020
    2NDC:79129-003-021000 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product03/30/2020
    Image of Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A03/30/2020
    Labeler - HONNES SAGLIK VE ENDUSTRIYEL URUNLERI ANONIM SIRKETI (519777302)
    Registrant - HARDAL GLOBAL CONSULTING LLC (123584960)
    Establishment
    NameAddressID/FEIBusiness Operations
    HONNES SAGLIK VE ENDUSTRIYEL URUNLERI ANONIM SIRKETI519777302manufacture(79129-003)
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