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Black Box Warning
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See full prescribing information for complete Boxed Warning.
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Content
Overview
Sodium hypochlorite is an anti- infective agent that is FDA approved for the treatment of infection of the skin and tissue. There is a Black Box Warning for this drug as shown here. Common adverse reactions include .
Adult Indications and Dosage
FDA-Labeled Indications and Dosage (Adult)
Infection of the skin and tissue
To prevent and treat infection of the skin and tissue.
Pre and post surgery- Cuts, abrasions and skin ulcers
Dosing Information
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 surrounding intact skin with a moisture barrier ointment or skin sealant as needed.
Off-Label Use and Dosage (Adult)
Guideline-Supported Use
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Developed by:
Class of Recommendation:
Strength of Evidence:
Dosing Information
Dosage
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There is limited information regarding Off-Label Guideline-Supported Use of Sodium hypochlorite in adult patients.
Non–Guideline-Supported Use
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Dosing Information
Dosage
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There is limited information regarding Off-Label Non–Guideline-Supported Use of Sodium hypochlorite in adult patients.
Pediatric Indications and Dosage
FDA-Labeled Indications and Dosage (Pediatric)
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Dosing Information
Dosage
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There is limited information regarding FDA-Labeled Use of Sodium hypochlorite in pediatric patients.
Off-Label Use and Dosage (Pediatric)
Guideline-Supported Use
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Developed by:
Class of Recommendation:
Strength of Evidence:
Dosing Information
Dosage
Condition2
There is limited information regarding Off-Label Guideline-Supported Use of Sodium hypochlorite in pediatric patients.
Non–Guideline-Supported Use
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Dosing Information
Dosage
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There is limited information regarding Off-Label Non–Guideline-Supported Use of Sodium hypochlorite in pediatric patients.
Contraindications
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Warnings
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See full prescribing information for complete Boxed Warning.
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Content
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.
Adverse Reactions
Clinical Trials Experience
There is limited information regarding Clinical Trial Experience of Sodium hypochlorite in the drug label.
Body as a Whole
Cardiovascular
Digestive
Endocrine
Hematologic and Lymphatic
Metabolic and Nutritional
Musculoskeletal
Neurologic
Respiratory
Skin and Hypersensitivy Reactions
Special Senses
Urogenital
Miscellaneous
Postmarketing Experience
There is limited information regarding Postmarketing Experience of Sodium hypochlorite in the drug label.
Australian Drug Evaluation Committee (ADEC) Pregnancy Category
There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of Sodium hypochlorite in women who are pregnant.
Labor and Delivery
There is no FDA guidance on use of Sodium hypochlorite during labor and delivery.
Nursing Mothers
There is no FDA guidance on the use of Sodium hypochlorite with respect to nursing mothers.
Pediatric Use
There is no FDA guidance on the use of Sodium hypochlorite with respect to pediatric patients.
Geriatic Use
There is no FDA guidance on the use of Sodium hypochlorite with respect to geriatric patients.
Gender
There is no FDA guidance on the use of Sodium hypochlorite with respect to specific gender populations.
Race
There is no FDA guidance on the use of Sodium hypochlorite with respect to specific racial populations.
Renal Impairment
There is no FDA guidance on the use of Sodium hypochlorite in patients with renal impairment.
Hepatic Impairment
There is no FDA guidance on the use of Sodium hypochlorite in patients with hepatic impairment.
Females of Reproductive Potential and Males
There is no FDA guidance on the use of Sodium hypochlorite in women of reproductive potentials and males.
Immunocompromised Patients
There is no FDA guidance one the use of Sodium hypochlorite in patients who are immunocompromised.
Administration and Monitoring
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 surrounding intact skin with a moisture barrier ointment or skin sealant as needed.
Monitoring
There is limited information regarding Monitoring of Sodium hypochlorite in the drug label.
Description
IV Compatibility
There is limited information regarding IV Compatibility of Sodium hypochlorite in the drug label.
Overdosage
Acute Overdose
Signs and Symptoms
Description
Management
Description
Chronic Overdose
There is limited information regarding Chronic Overdose of Sodium hypochlorite in the drug label.