Label: DAKINS QUARTER- sodium hypochlorite solution

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved drug other

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Drug Label Information

Updated February 7, 2019

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  • ACTIVE INGREDIENT

    Sodium Hypochlorite 0.125%

  • PURPOSE

    Antimicrobial

  • INDICATIONS & USAGE

    Uses

    To prevent and treat infections of the skin and tissue.

    Pre and post surgery.      Cuts, abrasions and skin ulcers.

  • WARNINGS

    For external use only.

  • STOP USE

    Stop use and ask a doctor if redness, irritation, swelling or pain persists or increases.

  • DO NOT USE

    Do not use if sensitive to chlorine compounds.

  • 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.

  • DOSAGE & ADMINISTRATION

    Directions

    Pour on or apply to affected area. For wound management, use as an irrigant, cleanser,

    or the wetting agent for a wet-to-moist dressing. Apply once daily for lightly to moderately exudative wounds.

    Apply twice daily for highly exudative or highly contaminated wounds. Protect intact skin with a

    moisture barrier ointment or skin sealant as needed.

  • STORAGE AND HANDLING

    Other Information

    Store at room temperature.

    May bleach clothing.

    Keep container closed when not using.

  • INACTIVE INGREDIENT

    Purified Water, Sodium Bicarbonate, Sodium Hydroxide

  • QUESTIONS

    Questions or Comments?

    (317) 849-4210 or 1-866-343-2576, Mon-Fri, 9AM to 4 PM EST

    Century Pharmaceuticals, Inc. - Indianapolis, IN 46256

  • PRINCIPAL DISPLAY PANEL

    dakinsquarter

  • INGREDIENTS AND APPEARANCE
    DAKINS QUARTER 
    sodium hypochlorite solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0436-0672
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SODIUM HYPOCHLORITE (UNII: DY38VHM5OD) (HYPOCHLORITE ION - UNII:T5UM7HB19N) SODIUM HYPOCHLORITE1.25 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    SODIUM BICARBONATE (UNII: 8MDF5V39QO)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0436-0672-16473 mL in 1 BOTTLE; Type 0: Not a Combination Product05/24/2006
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other05/24/2006
    Labeler - Century Pharmaceuticals, Inc. (042815464)
    Establishment
    NameAddressID/FEIBusiness Operations
    Century Pharmaceuticals, Inc.042815464analysis(0436-0672) , label(0436-0672) , manufacture(0436-0672) , pack(0436-0672)
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