BENADRYL EXTRA STRENGTH ITCH COOLING- diphenhydramine hydrochloride and zinc acetate spray

BENADRYL Extra Strength Itch Cooling by

Drug Labeling and Warnings

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

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

REQUIRED INFORMATION

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
• adults and children 2 years of age and older: spray on 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, PVP, purified water, tromethamine

Questions?

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

PRINCIPAL DISPLAY PANEL - 59 mL Bottle Label

EXTRA STRENGTH
Benadryl®
Topical Analgesic/Skin Protectant
ITCH COOLING SPRAY

Relief for most
outdoor itches

Insect
Bites

Poison Ivy,
Oak, Sumac

Mosquito
Bites

Sunburn

Minor Cuts
& Scrapes

2 FL OZ (59 mL)

INGREDIENTS AND APPEARANCE

BENADRYL EXTRA STRENGTH ITCH COOLING 
diphenhydramine hydrochloride and zinc acetate spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 58232-0750
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: 58232-0750-2	59 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product	04/01/2012

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH NOT FINAL	part348	04/01/2012

Labeler - Johnson & Johnson Consumer Inc. (002347102)