Diphenhydramine (topical)

Diphenhydramine (topical)
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: Adeel Jamil, M.D. [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

Diphenhydramine (topical) is an analgesic and antihistamine that is FDA approved for the treatment of pain and itching associated with insect bites, minor burns, sunburn, minor cuts, scrapes, minor skin irritations, rashes due to poison ivy, poison oak, and poison sumac. Common adverse reactions include xerostomia, sedation, and dizziness.

Adult Indications and Dosage

FDA-Labeled Indications and Dosage (Adult)

• temporarily relieves pain and itching associated with:

• insect bites
• minor burns
• sunburn
• minor cuts
• scrapes
• minor skin irritations
• rashes due to poison ivy, poison oak, and poison sumac

Dosing Information

• do not use more than directed
• adults and children 2 years of age and older: apply to affected area not more than 3 to 4 times daily
• children under 2 years of age: ask a doctor

Off-Label Use and Dosage (Adult)

Guideline-Supported Use

There is limited information regarding Off-Label Guideline-Supported Use of Diphenhydramine (topical) in adult patients.

Non–Guideline-Supported Use

There is limited information regarding Off-Label Non–Guideline-Supported Use of Diphenhydramine (topical) in adult patients.

Pediatric Indications and Dosage

FDA-Labeled Indications and Dosage (Pediatric)

There is limited information regarding Diphenhydramine (topical) 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 Diphenhydramine (topical) in pediatric patients.

Non–Guideline-Supported Use

There is limited information regarding Off-Label Non–Guideline-Supported Use of Diphenhydramine (topical) in pediatric patients.

Contraindications

There is limited information regarding Diphenhydramine (topical) Contraindications in the drug label.

Warnings

• For external use only.

Do not use

• on large areas of the body
• with any other product containing diphenhydramine, even one taken by mouth

Ask a doctor before use

• on chicken pox
• on measles

When using this product avoid contact with eyes

Stop use and ask a doctor if

• condition worsens
• symptoms persist for more than 7 days or clear up and occur again within a few days

Keep out of reach of children

• If swallowed, get medical help or contact a Poison Control Center right

Adverse Reactions

Clinical Trials Experience

There is limited information regarding Diphenhydramine (topical) Clinical Trials Experience in the drug label.

Postmarketing Experience

There is limited information regarding Diphenhydramine (topical) Postmarketing Experience in the drug label.

Drug Interactions

There is limited information regarding Diphenhydramine (topical) Drug Interactions in the drug label.

Use in Specific Populations

Pregnancy

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

Labor and Delivery

There is no FDA guidance on use of Diphenhydramine (topical) during labor and delivery.

Nursing Mothers

There is no FDA guidance on the use of Diphenhydramine (topical) in women who are nursing.

Pediatric Use

There is no FDA guidance on the use of Diphenhydramine (topical) in pediatric settings.

Geriatic Use

There is no FDA guidance on the use of Diphenhydramine (topical) in geriatric settings.

Gender

There is no FDA guidance on the use of Diphenhydramine (topical) with respect to specific gender populations.

Race

There is no FDA guidance on the use of Diphenhydramine (topical) with respect to specific racial populations.

Renal Impairment

There is no FDA guidance on the use of Diphenhydramine (topical) in patients with renal impairment.

Hepatic Impairment

There is no FDA guidance on the use of Diphenhydramine (topical) in patients with hepatic impairment.

Females of Reproductive Potential and Males

There is no FDA guidance on the use of Diphenhydramine (topical) in women of reproductive potentials and males.

Immunocompromised Patients

There is no FDA guidance one the use of Diphenhydramine (topical) in patients who are immunocompromised.

Administration and Monitoring

Administration

There is limited information regarding Diphenhydramine (topical) Administration in the drug label.

Monitoring

There is limited information regarding Diphenhydramine (topical) Monitoring in the drug label.

IV Compatibility

There is limited information regarding the compatibility of Diphenhydramine (topical) and IV administrations.

Overdosage

There is limited information regarding Diphenhydramine (topical) overdosage. If you suspect drug poisoning or overdose, please contact the National Poison Help hotline (1-800-222-1222) immediately.

Pharmacology

Diphenhydramine (topical)
Systematic (IUPAC) name
2-(diphenylmethoxy)-N,N-dimethylethanamine
Identifiers
CAS number	58-73-1
ATC code	D04AA32 D04AA33 (WHO), R06AA02 (WHO)
PubChem	3100
DrugBank	DB01075
Chemical data
Formula	Template:OrganicBox atomTemplate:OrganicBox atomTemplate:OrganicBoxTemplate:OrganicBoxTemplate:OrganicBoxTemplate:OrganicBoxTemplate:OrganicBoxTemplate:OrganicBoxTemplate:OrganicBoxTemplate:OrganicBoxTemplate:OrganicBoxTemplate:OrganicBoxTemplate:OrganicBoxTemplate:OrganicBox atomTemplate:OrganicBoxTemplate:OrganicBox atomTemplate:OrganicBoxTemplate:OrganicBoxTemplate:OrganicBoxTemplate:OrganicBoxTemplate:OrganicBoxTemplate:OrganicBoxTemplate:OrganicBox
Mol. mass	255.355 g/mol
SMILES	eMolecules & PubChem
Pharmacokinetic data
Bioavailability	40–60%
Protein binding	98–99%
Metabolism	Various cytochrome P450 liver enzymes: CYP2D6 (80%), 3A4 (10%)
Half life	8 hours (children) 9 to 12 hours (adults) 17 hours (elderly)
Excretion	94% through the urine, 6% through feces
Therapeutic considerations
Pregnancy cat.	A(AU) B(US)
Legal status	Pharmacy Only (S2)(AU) Over-the-counter
Dependence Liability	Very low
Routes	Oral, parenteral (IM and IV), topical, suppository

Mechanism of Action

There is limited information regarding Diphenhydramine (topical) Mechanism of Action in the drug label.

Structure

There is limited information regarding Diphenhydramine (topical) Structure in the drug label.

Pharmacodynamics

There is limited information regarding Diphenhydramine (topical) Pharmacodynamics in the drug label.

Pharmacokinetics

There is limited information regarding Diphenhydramine (topical) Pharmacokinetics in the drug label.

Nonclinical Toxicology

There is limited information regarding Diphenhydramine (topical) Nonclinical Toxicology in the drug label.

Clinical Studies

There is limited information regarding Diphenhydramine (topical) Clinical Studies in the drug label.

How Supplied

There is limited information regarding Diphenhydramine (topical) How Supplied in the drug label.

Storage

• Store at Room Temperature

Images

Drug Images

{{#ask: Page Name::Diphenhydramine (topical) |?Pill Name |?Drug Name |?Pill Ingred |?Pill Imprint |?Pill Dosage |?Pill Color |?Pill Shape |?Pill Size (mm) |?Pill Scoring |?NDC |?Drug Author |format=template |template=DrugPageImages |mainlabel=- |sort=Pill Name }}

Package and Label Display Panel

PRINCIPAL DISPLAY PANEL - 103 ML TUBE LABEL

NEW LOOK and SIZE SAME FORMULA!

EXTRA STRENGTH

Benadryl®

ITCH STOPPING GEL Diphenhydramine Hydrochloride

FOR SKIN USE ONLY

Cooling relief for Most outdoor itches

Insect Bites

Poison Ivy, Oak, Sumac

Mosquito Bites

Sunburn

Minor Cuts & Scrapes

3.5 FL OZ (103 mL)

This image is provided by the National Library of Medicine.

This image is provided by the National Library of Medicine.

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Patient Counseling Information

There is limited information regarding Diphenhydramine (topical) Patient Counseling Information in the drug label.

Precautions with Alcohol

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

Brand Names

• Benadryl

Look-Alike Drug Names

There is limited information regarding Diphenhydramine (topical) 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.