Hexachlorophene

Hexachlorophene
Adult Indications & Dosage
Pediatric Indications & Dosage
Contraindications
Warnings & Precautions
Adverse Reactions
Drug Interactions
Use in Specific Populations
Administration & Monitoring
Overdosage
Pharmacology
Clinical Studies
How Supplied
Images
Patient Counseling Information
Precautions with Alcohol
Brand Names
Look-Alike Names

Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]; Associate Editor(s)-in-Chief: Alberto Plate [2]

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Overview

Hexachlorophene is an antibacterial cleansing agent that is FDA approved for the procedure of surgical scrubing and a bacteriostatic skin cleanser. It may also be used to control an outbreak of gram-positive infection where other infection control procedures have been unsuccessful. Use only as long as necessary for infection control. Common adverse reactions include dermatitis, photosensitivity.

Adult Indications and Dosage

FDA-Labeled Indications and Dosage (Adult)

There is limited information regarding Hexachlorophene FDA-Labeled Indications and Dosage (Adult) in the drug label.

Off-Label Use and Dosage (Adult)

Guideline-Supported Use

There is limited information regarding Off-Label Guideline-Supported Use of Hexachlorophene in adult patients.

Non–Guideline-Supported Use

There is limited information regarding Off-Label Non–Guideline-Supported Use of Hexachlorophene in adult patients.

Pediatric Indications and Dosage

FDA-Labeled Indications and Dosage (Pediatric)

There is limited information regarding Hexachlorophene FDA-Labeled Indications and Dosage (Pediatric) in the drug label.

Off-Label Use and Dosage (Pediatric)

Guideline-Supported Use

There is limited information regarding Off-Label Guideline-Supported Use of Hexachlorophene in pediatric patients.

Non–Guideline-Supported Use

There is limited information regarding Off-Label Non–Guideline-Supported Use of Hexachlorophene in pediatric patients.

Contraindications

• pHisoHex must not be used on burned or denuded skin.
• pHisoHex must not be used for bathing infants. Infants may absorb the active compound in pHisoHex more readily than older children and adults. Such absorption has been associated with central nervous system effects such as convulsions.
• It must not be used as an occlusive dressing, wetpack, or lotion. It must not be used routinely for prophylactic total body bathing.
• It must not be used as a vaginal pack or tampon, or on any mucous membranes.
• pHisoHex must not be used on persons with sensitivity to any of its components. It must not be used on persons who have demonstrated primary light sensitivity to halogenated phenol derivatives because of the possibility of cross-sensitivity to hexachlorophene.

Warnings

RINSE THOROUGHLY AFTER EACH USE

• Patients should be closely monitored and use should be immediately discontinued at the first sign of any of the symptoms described below.
• Rapid absorption of hexachlorophene may occur with resultant toxic blood levels when preparations containing hexachlorophene are applied to skin lesions such as ichthyosis congenita, the dermatitis of Letterer-Siwe's syndrome, or other generalized dermatological conditions. Application to burns has also produced neurotoxicity and death.

pHisoHex SHOULD BE DISCONTINUED PROMPTLY IF SIGNS OR SYMPTOMS OF CEREBRAL IRRITABILITY OCCUR.

• Infants, especially premature infants or those with dermatoses, are particularly susceptible to hexachlorophene absorption. Systemic toxicity may be manifested by signs of stimulation (irritation) of the central nervous system, sometimes with convulsions.
• Infants have developed dermatitis, irritability, generalized clonic muscular contractions and decerebrate rigidity following application of a 6 percent hexachlorophene powder. Examination of brainstems of those infants revealed vacuolization like that which can be produced in newborn experimental animals following repeated topical application of 3 percent hexachlorophene. Moreover, a study of histologic sections of premature infants who died of unrelated causes has shown a positive correlation between hexachlorophene baths and lesions in white matter of brains.

Adverse Reactions

Clinical Trials Experience

Adverse reactions to pHisoHex may include dermatitis and photosensitivity. Sensitivity to hexachlorophene is rare; however, persons who have developed photoallergy to similar compounds also may become sensitive to hexachlorophene.

In persons with highly sensitive skin the use of pHisoHex may at times produce a reaction characterized by redness and/or mild scaling or dryness, especially when it is combined with such mechanical factors as excessive rubbing or exposure to heat or cold.

Postmarketing Experience

There is limited information regarding Hexachlorophene Postmarketing Experience in the drug label.

Drug Interactions

There is limited information regarding Hexachlorophene Drug Interactions in the drug label.

Use in Specific Populations

Pregnancy

Pregnancy Category (FDA): There is no FDA guidance on usage of Hexachlorophene in women who are pregnant.
Pregnancy Category (AUS): There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of Hexachlorophene in women who are pregnant.

Labor and Delivery

There is no FDA guidance on use of Hexachlorophene during labor and delivery.

Nursing Mothers

There is no FDA guidance on the use of Hexachlorophene in women who are nursing.

Pediatric Use

There is no FDA guidance on the use of Hexachlorophene in pediatric settings.

Geriatic Use

There is no FDA guidance on the use of Hexachlorophene in geriatric settings.

Gender

There is no FDA guidance on the use of Hexachlorophene with respect to specific gender populations.

Race

There is no FDA guidance on the use of Hexachlorophene with respect to specific racial populations.

Renal Impairment

There is no FDA guidance on the use of Hexachlorophene in patients with renal impairment.

Hepatic Impairment

There is no FDA guidance on the use of Hexachlorophene in patients with hepatic impairment.

Females of Reproductive Potential and Males

There is no FDA guidance on the use of Hexachlorophene in women of reproductive potentials and males.

Immunocompromised Patients

There is no FDA guidance one the use of Hexachlorophene in patients who are immunocompromised.

Administration and Monitoring

Administration

There is limited information regarding Hexachlorophene Administration in the drug label.

Monitoring

There is limited information regarding Hexachlorophene Monitoring in the drug label.

IV Compatibility

There is limited information regarding the compatibility of Hexachlorophene and IV administrations.

Overdosage

The accidental ingestion of pHisoHex in amounts from 1 oz to 4 oz has caused anorexia, vomiting, abdominal cramps, diarrhea, dehydration, convulsions, hypotension, and shock, and in several reported instances, fatalities.

If patients are seen early, the stomach should be evacuated by emesis or gastric lavage. Olive oil or vegetable oil (60 mL or 2 fl oz) may then be given to delay absorption of hexachlorophene, followed by a saline cathartic to hasten removal. Treatment is symptomatic and supportive; intravenous fluids (5 percent dextrose in physiologic saline solution) may be given for dehydration. Any other electrolyte derangement should be corrected. If marked hypotension occurs, vasopressor therapy is indicated. Use of opiates may be considered if gastrointestinal symptoms (cramping, diarrhea) are severe. Scheduled medical or surgical procedures should be postponed until the patient's condition has been evaluated and stabilized.

Pharmacology

There is limited information regarding Hexachlorophene Pharmacology in the drug label.

Mechanism of Action

There is limited information regarding Hexachlorophene Mechanism of Action in the drug label.

Structure

There is limited information regarding Hexachlorophene Structure in the drug label.

Pharmacodynamics

There is limited information regarding Hexachlorophene Pharmacodynamics in the drug label.

Pharmacokinetics

There is limited information regarding Hexachlorophene Pharmacokinetics in the drug label.

Nonclinical Toxicology

There is limited information regarding Hexachlorophene Nonclinical Toxicology in the drug label.

Clinical Studies

There is limited information regarding Hexachlorophene Clinical Studies in the drug label.

How Supplied

There is limited information regarding Hexachlorophene How Supplied in the drug label.

Storage

There is limited information regarding Hexachlorophene Storage in the drug label.

Images

Drug Images

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Package and Label Display Panel

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Patient Counseling Information

There is limited information regarding Hexachlorophene Patient Counseling Information in the drug label.

Precautions with Alcohol

Alcohol-Hexachlorophene interaction has not been established. Talk to your doctor about the effects of taking alcohol with this medication.

Brand Names

There is limited information regarding Hexachlorophene Brand Names in the drug label.

Look-Alike Drug Names

There is limited information regarding Hexachlorophene Look-Alike Drug Names in the drug label.

Drug Shortage Status

Price

References

The contents of this FDA label are provided by the National Library of Medicine.

Hexachlorophene

File:Hexachlorophene.png
Clinical data
ATC code	D08AE01 (WHO)
Pharmacokinetic data
Protein binding	92%
Identifiers
IUPAC name 3,4,6-trichloro-2- [(2,3,5-trichloro-6-hydroxy-phenyl) methyl]phenol
CAS Number	70-30-4
PubChem CID	3598
DrugBank	APRD00722
E number	{{#property:P628}}
ECHA InfoCard	{{#property:P2566}}
Chemical and physical data
Formula	C13H6Cl6O2
Molar mass	406.902 g/mol
Melting point	164 °C (327.2 °F)

Hexachlorophene, also known as Nabac, is an antiseptic agent. The compound occurs as a white to light tan crystalline powder which is either odorless or produces a slightly phenolic odor. In medicine, hexachlorophene is very useful as a topical anti-infective, anti-bacterial agent, often used in soaps. It is also used in agriculture as a soil fungicide, plant bactericide, and acaricide.

Two companies had over the counter brands available. One, by The Mennen Company, Morristown, NJ, was known as Baby Magic Bath. Mennen recalled the product and all bottles were taken off retail shelves. Right after the withdrawal, there was an outbreak of Staphylococcus infections in hospitals across the USA.

During the 1960s, a commercial preparation of the drug, pHisoHex, was available over the counter. pHisoHex was widely used as a very effective antibacterial skin cleanser in the treatment of acne. A related product, pHisoAc, was used as a skin mask to dry and peel away acne lesions. Another known as Phiso-Scrub was a hexachlorophene-impregnated sponge for scrubbing; it has since been discontinued.

In 1969 hexachlorophene became suspected of causing cancer. Around 1973 it was withdrawn from over-the-counter sales as a treatment for acne and became a prescription drug. It was later determined not to cause cancer. Nevertheless, hexachlorophene soap is not available over the counter today, because once a product has been withdrawn by the FDA it is virtually impossible for it to be reinstated, even after invalidation of the reasons for its removal. The MSDS still lists this compound as an experimental teratogen.

Possibly because of the previous questions concerning its effects, most dermatologists today do not prescribe it for acne treatment.

Several substitute products (including triclosan) were developed, but none had the germ-killing capability of hexachlorophene.