LEADER ANTI ITCH- diphenhydramine hydrochloride, zinc acetate cream

leader anti itch by

Drug Labeling and Warnings

leader anti itch by is a Otc medication manufactured, distributed, or labeled by Cardinal Health. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient

Diphenhydramine hydrochloride 2%

Zinc acetate 0.1%

Purpose

Topical analgesic

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 the 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 no more than 3 to 4 times daily
• children under 2 years of age: ask a doctor

Other information

• store at 20°-25°C (68°-77°F)

Inactive ingredients

cetyl alcohol, diazolidinyl urea, methylparaben, PEG-2 stearate, PEG-20 stearate, propylene glycol, propylparaben, purified water

Questions or comments?

1-800-719-9260

Principal Display Panel

Extra Strength

Anti-Itch Cream

Diphenhydramine Hydrochloride, 2% | Zinc Acetate, 0.1%

Topical Analgesic | Skin Protectant

Itch Stopping Cream

COMPARE TO EXTRA STRENGTH BENADRYL® CREAM active ingredients

100% Money Back Guarantee

NET WT 1 OZ (28 g)

INGREDIENTS AND APPEARANCE

LEADER ANTI ITCH 
diphenhydramine hydrochloride, zinc acetate cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 70000-0388
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M)	DIPHENHYDRAMINE HYDROCHLORIDE	2 g  in 100 g
ZINC ACETATE (UNII: FM5526K07A) (ZINC CATION - UNII:13S1S8SF37)	ZINC ACETATE	0.1 g  in 100 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)
PEG-2 STEARATE (UNII: 94YQ11Y95F)
PEG-20 STEARATE (UNII: NBX892EA57)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 70000-0388-1	1 in 1 CARTON	12/13/2018
1		28 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	12/13/2018

Labeler - Cardinal Health (097537435)