Otc - Active Ingredient
Sodium Hypochlorite 0.25%
Dakins Half Solution
FDA Label NDC 0436-0936
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Century Pharmaceuticals, Inc. for the product Dakins Half (NDC 0436-0936). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding otc - active ingredient, otc - purpose, indications & usage, warnings, otc - stop use, otc - do not use, otc - keep out of reach of children, dosage & administration, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - 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.
Otc - Stop Use
Stop use and ask a doctor if redness, irritation, swelling or pain persists or increases.
Otc - Do Not Use
Do not use if sensitive to chlorine compounds.
Otc - 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
Otc - 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
Package Label.Principal Display Panel
Dakinshalf (Dakinshalf)
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