Diphenhydramine (topical)

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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.

• 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

• 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

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

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

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

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

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

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

• 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

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

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

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

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.

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

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

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

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

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

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

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

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

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

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

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

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

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

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.

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

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

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

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

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

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

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

• Store at Room Temperature

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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)

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

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

• Benadryl

There is limited information regarding Diphenhydramine (topical) Look-Alike Drug Names in the drug label.

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