Diphenhydramine (topical)

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# 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.

### NonGuideline-Supported Use
There is limited information regarding Off-Label NonGuideline-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.

### NonGuideline-Supported Use
There is limited information regarding Off-Label NonGuideline-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.
- on large areas of the body
- with any other product containing diphenhydramine, even one taken by mouth
- on chicken pox
- on measles
- condition worsens
- symptoms persist for more than 7 days or clear up and occur again within a few days
- 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

## 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
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)

# 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