Dakins Quarter: Package Insert and Label Information

DAKINS QUARTER- sodium hypochlorite solution
Century Pharmaceuticals, Inc.

Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

Sodium Hypochlorite 0.125%

Antimicrobial

Uses

To prevent and treat infections of the skin and tissue.

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

For external use only.

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

Do not use if sensitive to chlorine compounds.

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

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.

Other Information

Store at room temperature.

May bleach clothing.

Keep container closed when not using.

Purified Water, Sodium Bicarbonate, Sodium Hydroxide

Questions or Comments?

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

Century Pharmaceuticals, Inc. — Indianapolis, IN 46256

dakinsquarter
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DAKINS QUARTER
sodium hypochlorite solution
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:0436-0672
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
SODIUM HYPOCHLORITE (HYPOCHLORITE ION) SODIUM HYPOCHLORITE 1.25 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
SODIUM HYDROXIDE
SODIUM BICARBONATE
WATER
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0436-0672-16 473 mL in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
unapproved drug other 05/24/2006
Labeler — Century Pharmaceuticals, Inc. (042815464)
Establishment
Name Address ID/FEI Operations
Century Pharmaceuticals, Inc. 042815464 analysis (0436-0672), label (0436-0672), manufacture (0436-0672), pack (0436-0672)

Revised: 02/2019 Century Pharmaceuticals, Inc.

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