Label: ADRIANA GOLD- antibacterial hand soap chloroxylenol 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 January 16, 2018

If you are a consumer or patient please visit this version.

  • ​Drug Facts
  • ​Active ingredient

    Chloroxylenol 0.3%

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  • ​Purpose

    Antibacterial

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  • ​Uses

    for hand washing to decrease bacteria on the skin.

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  • ​Warnings

    ​For external use only.

    When using this product avoid contact with eyes. In case of eye contact, flush with water.

    Stop use and ask a doctor if irritation and redness develops.​​​​​​

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  • 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.

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  • ​Directions

    • wet hands as needed • lather vigorously for at least 15 seconds • rinse and dry thoroughly.

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  • ​Inactive ingredients

    Water, Sodium laureth Sulfate, Cocamidopropyl Betaine, Sodium Lauryl Sulfate, Sodium Chloride, Fragrance, Citric Acid, PEG-150 Distearate, Methylchloroisothiazolinone, Methylisothiazolinone, Blue No. 1, Red No.33

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  • SPL UNCLASSIFIED SECTION

    ​Kills Germs and Odors

    Imported by:

    O.S.T.L.Inc

    Distributor:

    VERNON SALES .INC

    www.ostltrade.com
    ​​​​

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  • Packaging
  • INGREDIENTS AND APPEARANCE
    ADRIANA GOLD 
    antibacterial hand soap chloroxylenol liquid
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:69950-010
    Route of Administration TOPICAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    CHLOROXYLENOL (UNII: 0F32U78V2Q) (CHLOROXYLENOL - UNII:0F32U78V2Q) CHLOROXYLENOL 0.3 g  in 100 mL
    Inactive Ingredients
    Ingredient Name Strength
    WATER (UNII: 059QF0KO0R)  
    SODIUM LAURETH-3 SULFATE (UNII: BPV390UAP0)  
    COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    PEG-150 DISTEARATE (UNII: 6F36Q0I0AC)  
    METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN)  
    METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    D&C RED NO. 33 (UNII: 9DBA0SBB0L)  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:69950-010-01 444 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 01/31/2018
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph not final part333E 01/31/2018
    Labeler - OSTL, INC. (020117798)
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