BENADRYL EXTRA STRENGTH ITCH STOPPING- diphenhydramine hydrochloride and zinc acetate cream

Benadryl Extra Strength by

Drug Labeling and Warnings

Benadryl Extra Strength 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

Drug Facts

ACTIVE INGREDIENT

Active ingredients	Purpose
Diphenhydramine hydrochloride 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

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: apply to affected area not more than 3 to 4 times daily
• children under 2 years of age: ask a doctor

Other information

• protect from excessive heat (40°C/104°F)

Inactive ingredients

cetyl alcohol, diazolidinyl urea, methylparaben, polyethylene glycol monostearate 1000, propylene glycol, propylparaben, purified water

Questions?

Call toll-free 800-524-2624 (English/Spanish)or 215-273-8755 (collect)

SPL UNCLASSIFIED SECTION

Distributed by:
JOHNSON & JOHNSON CONSUMER INC.
Skillman, NJ 08558

PRINCIPAL DISPLAY PANEL - 28.3 g Tube Carton

EXTRA STRENGTH

Benadryl®

Topical Analgesic/Skin Protectant

ITCH
STOPPING
CREAM

NET WT 1 OZ (28.3 g)

INGREDIENTS AND APPEARANCE

BENADRYL EXTRA STRENGTH   ITCH STOPPING
diphenhydramine hydrochloride and zinc acetate cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69968-0223
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 g
Zinc Acetate (UNII: FM5526K07A) (Zinc Cation - UNII:13S1S8SF37)	Zinc Acetate	1 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
Cetyl Alcohol (UNII: 936JST6JCN)
Diazolidinyl Urea (UNII: H5RIZ3MPW4)
Methylparaben (UNII: A2I8C7HI9T)
Propylene Glycol (UNII: 6DC9Q167V3)
Propylparaben (UNII: Z8IX2SC1OH)
Water (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69968-0223-1	1 in 1 CARTON	11/01/2009
1		28.3 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	11/01/2009

Labeler - Johnson & Johnson Consumer Inc. (002347102)