Diphenhydramine (topical)

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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
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

Template:Px
Template:Px
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
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Mol. mass 255.355 g/mol
SMILES eMolecules & PubChem
Pharmacokinetic data
Bioavailability 40–60%[1]
Protein binding 98–99%
Metabolism Various cytochrome P450 liver enzymes: CYP2D6 (80%), 3A4 (10%)[2]
Half life 8 hours (children)[3]
9 to 12 hours (adults)[3]
17 hours (elderly)[3]
Excretion 94% through the urine, 6% through feces[4]
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

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.

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.

  1. Paton DM, Webster DR (1985). "Clinical pharmacokinetics of H1-receptor antagonists (the antihistamines)". Clin. Pharmacokinet. 10 (6): 477–97. doi:10.2165/00003088-198510060-00002. PMID 2866055.
  2. "Showing Diphenhydramine (DB01075)". DrugBank. Retrieved 5 September 2009.
  3. 3.0 3.1 3.2 Simons KJ, Watson WT, Martin TJ, Chen XY, Simons FE (July 1990). "Diphenhydramine: pharmacokinetics and pharmacodynamics in elderly adults, young adults, and children". J. Clin. Pharmacol. 30 (7): 665–71. doi:10.1002/j.1552-4604.1990.tb01871.x. PMID 2391399.
  4. Garnett WR (February 1986). "Diphenhydramine". Am. Pharm. NS26 (2): 35–40. PMID 3962845.