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Benadryl Itch Stopping Gel Prescribing Information

Package insert / product label
Generic name: diphenhydramine hydrochloride
Dosage form: gel
Drug class: Topical antihistamines

Medically reviewed by Drugs.com. Last updated on Dec 22, 2022.

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Facts

Active ingredient

Diphenhydramine HCl 2%

Purpose

Topical analgesic

Use

  • 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

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 away.

Directions

  • 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

Other information

Store at Room Temperature

Inactive ingredients

SD alcohol 38-B, camphor, citric acid, diazolidinyl urea, glycerin, hydroxypropyl methylcellulose, methylparaben, propylene glycol, propylparaben, purified water, sodium citrate

Questions?

call toll-free 800-524-2624 or 215-273-8755 (collect)

Distributed by:
JOHNSON & JOHNSON
CONSUMER INC.

Skillman, NJ 08558

PRINCIPAL DISPLAY PANEL - 103 mL Tube Label

EXTRA STRENGTH

Benadryl ®

ITCH STOPPING
GEL
Diphenhydramine
Hydrochloride
Topical Analgesic

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)

BENADRYL EXTRA STRENGTH ITCH STOPPING
diphenhydramine hydrochloride gel
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:69968-0242
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
DIPHENHYDRAMINE HYDROCHLORIDE (DIPHENHYDRAMINE) DIPHENHYDRAMINE HYDROCHLORIDE 20 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
ALCOHOL
CAMPHOR (SYNTHETIC)
CITRIC ACID MONOHYDRATE
DIAZOLIDINYL UREA
GLYCERIN
HYPROMELLOSE, UNSPECIFIED
METHYLPARABEN
PROPYLENE GLYCOL
PROPYLPARABEN
WATER
SODIUM CITRATE, UNSPECIFIED FORM
Packaging
# Item Code Package Description
1 NDC:69968-0242-3 103 mL in 1 TUBE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part348 10/01/2013
Labeler - Johnson & Johnson Consumer Inc. (002347102)
Johnson & Johnson Consumer Inc.

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