Hexylresorcinol

Hexylresorcinol
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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NOTE: Most over the counter (OTC) are not reviewed and approved by the FDA. However, they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Overview

Hexylresorcinol is an oral anesthetic that is FDA approved for the treatment of toothaches and pain due to braces, dentures and minor dental procedures. Common adverse reactions include hypersensitivity reactions.

Adult Indications and Dosage

FDA-Labeled Indications and Dosage (Adult)

• Shake lightly before use
• Adults and children 2 years and older, apply to affected area up to 4 times daily or as directed by a dentist or doctor
• Children under 12 years of age should be supervised when using this product
• Children under 2, ask a doctor
• Spray directly, apply with Q-tip or spray on cotton ball or gauze and apply.

Off-Label Use and Dosage (Adult)

Guideline-Supported Use

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

Non–Guideline-Supported Use

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

Pediatric Indications and Dosage

FDA-Labeled Indications and Dosage (Pediatric)

There is limited information regarding Hexylresorcinol 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 Hexylresorcinol in pediatric patients.

Non–Guideline-Supported Use

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

Contraindications

There is limited information regarding Hexylresorcinol Contraindications in the drug label.

Warnings

Allergy alert:

• Do not use this product if you have a history of allergy to clove or its component, eugenol.
• Do not swallow

Stop use and ask a doctor if:

• Symptoms do not improve in 7 days
• Irritation, pain, or redness persists or worsens.
• Swelling, rash or fever develops.

Adverse Reactions

Clinical Trials Experience

There is limited information regarding Hexylresorcinol Clinical Trials Experience in the drug label.

Postmarketing Experience

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

Drug Interactions

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

Use in Specific Populations

Pregnancy

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

Labor and Delivery

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

Nursing Mothers

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

Pediatric Use

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

Geriatic Use

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

Gender

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

Race

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

Renal Impairment

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

Hepatic Impairment

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

Females of Reproductive Potential and Males

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

Immunocompromised Patients

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

Administration and Monitoring

Administration

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

Monitoring

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

IV Compatibility

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

Overdosage

• In case of overdose, get medical help or contact a Poison Control Center right away.

Pharmacology

Mechanism of Action

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

Structure

Pharmacodynamics

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

Pharmacokinetics

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

Nonclinical Toxicology

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

Clinical Studies

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

How Supplied

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

Storage

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

Precautions with Alcohol

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

Brand Names

• Avapta

Look-Alike Drug Names

There is limited information regarding Hexylresorcinol 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.

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