Drug Facts

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 or comments?

ca ll 1-877-717-2824 tol l-free or 215-273-8755 (co llect) www.benadryl.com

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

PRINCIPAL DISPLAY PANEL - 28.3 g Tube Carton

Benadryl® ®

THE HISTAMINE

BLOCKER TM

Relief from most outdoor itches

EXTRA STRENGTH

For Ages 2+

ITCH STOPPING

CREAM

Diphenhydramine HCl 2%

/ Topical Analgesic

Zinc acetate 0.1% / Skin

Protectant

Insect Bites

Poison Ivy,

Oak, Sumac

Mosquito

Bites

Sunburn

Minor Cuts

& Scrapes

NET WT.1 OZ (28.3g)

Benadryl_01

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

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
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

Ingredient Name	Strength
Inactive Ingredients
CETYL ALCOHOL (UNII: 936JST6JCN)
DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)
METHYLPARABEN (UNII: A2I8C7HI9T)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
WATER (UNII: 059QF0KO0R)

#	Item Code	Package Description	Marketing Start Date
Packaging
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
2	NDC:69968-0223-2	28.3 g in 1 TUBE; Type 0: Not a Combination Product	11/01/2009

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC Monograph Drug	M017	11/01/2009

Labeler - Johnson & Johnson Consumer Inc. (118772437)