BENADRYL EXTRA STRENGTH ITCH STOPPING- diphenhydramine hydrochloride gel

Benadryl Extra Strength Itch Stopping by

Drug Labeling and Warnings

Benadryl Extra Strength Itch Stopping by is a Otc medication manufactured, distributed, or labeled by Johnson & Johnson Consumer Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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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)

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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)

INGREDIENTS AND APPEARANCE

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

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Diphenhydramine Hydrochloride (UNII: TC2D6JAD40) (Diphenhydramine - UNII:8GTS82S83M)	Diphenhydramine Hydrochloride	20 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
ALCOHOL (UNII: 3K9958V90M)
CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET)
Citric Acid Monohydrate (UNII: 2968PHW8QP)
Diazolidinyl Urea (UNII: H5RIZ3MPW4)
Glycerin (UNII: PDC6A3C0OX)
Hypromellose, Unspecified (UNII: 3NXW29V3WO)
Methylparaben (UNII: A2I8C7HI9T)
Propylene Glycol (UNII: 6DC9Q167V3)
Propylparaben (UNII: Z8IX2SC1OH)
Water (UNII: 059QF0KO0R)
Sodium Citrate, Unspecified Form (UNII: 1Q73Q2JULR)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69968-0242-3	103 mL in 1 TUBE; Type 0: Not a Combination Product	10/01/2013

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)