BENADRYL EXTRA STRENGTH ITCH RELIEF- diphenhydramine hydrochloride and zinc acetate solution

Benadryl Extra Strength Itch Relief by

Drug Labeling and Warnings

Benadryl Extra Strength Itch Relief 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

Active ingredients	Purpose
Diphenhydramine HCl 2%	Topical analgesic
Zinc acetate 0.1%	Skin protectant

Uses

• temporarily relieves pain and itching associated with:
  • insect bites
  • minor burns
  • sunburn
  • minor skin irritations
  • minor cuts
  • scrapes
  • rashes due to poison ivy, poison oak, and poison sumac
• dries the oozing and weeping of poison ivy, poison oak, and poison sumac

Warnings

For external use only.

Flammable. Keep away from fire or flame.

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 or does not improve within 7 days
• 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
• hold stick straight down over affected skin area
• press tip of stick repeatedly on affected skin area until liquid flows, then dab sparingly
• 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 20° to 25°C (68° to 77°F)

Inactive ingredients

alcohol, glycerin, povidone, purified water, tromethamine

Questions?

call 1-800-524-2624 (English/Spanish)

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Dist: Johnson & Johnson
Consumer Products Company
Division of Johnson & Johnson
Consumer Companies Inc.
Skillman, NJ 08558 USA

PRINCIPAL DISPLAY PANEL - 14 mL Applicator Carton

EXTRA STRENGTH
Benadryl®
Topical Analgesic/Skin Protectant

ITCH
RELIEF
STICK

Apply
directly
to insect
bites

Starts working
on contact

Relieves itch
and pain

For adults
and kids 2+

Insect
Bites

Mosquito
Bites

0.47 FL OZ (14 mL)

INGREDIENTS AND APPEARANCE

BENADRYL EXTRA STRENGTH ITCH RELIEF 
diphenhydramine hydrochloride and zinc acetate solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 58232-0742
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
Zinc Acetate (UNII: FM5526K07A) (Zinc Cation - UNII:13S1S8SF37)	Zinc Acetate	1 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
Alcohol (UNII: 3K9958V90M)
glycerin (UNII: PDC6A3C0OX)
POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)
Water (UNII: 059QF0KO0R)
Tromethamine (UNII: 023C2WHX2V)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 58232-0742-6	1 in 1 CARTON	04/01/2012
1		14 mL in 1 APPLICATOR; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part347	04/01/2012

Labeler - Johnson & Johnson Consumer Inc. (002347102)