LEADER ANTI ITCH MAXIMUM STRENGTH- diphenhydramine hydrochloride, zinc acetate cream

LEADER ANTI ITCH MAXIMUM STRENGTH by

Drug Labeling and Warnings

LEADER ANTI ITCH MAXIMUM STRENGTH by is a Otc medication manufactured, distributed, or labeled by CARDINAL HEALTH. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active ingredients                                                                             Purpose

Diphenhydramine Hydrochloride 2%....................................................Topical analgesic

Zinc acetate 0.1%.............................................................................Skin protectant

PURPOSE

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

Warnings

For external use only.

DO NOT USE

Do not use

• on large areas of the body
• with any other product containing diphenhydramine, even one taken by mouth

ASK DOCTOR

Ask a doctor before use

• on chicken pox
• on measles
  

WHEN USING

When using this product

• avoid contact with eyes
  

STOP USE

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

Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center

INDICATIONS & USAGE

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
  

STORAGE AND HANDLING

Other information

• Store between 20 oC and 25 oC (68 oF and 77 oF)
  

INACTIVE INGREDIENT

Inactive ingredients

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

DOSAGE & ADMINISTRATION

DISTRIBUTED BY CARDINAL HEALTH

DULIN, OHIO 43017

CIN 2372134

www.myleader.com

1-800-200-6313

PRINCIPAL DISPLAY PANEL

Enter section text here

INGREDIENTS AND APPEARANCE

LEADER ANTI ITCH MAXIMUM STRENGTH 
diphenhydramine hydrochloride, zinc acetate cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 37205-278
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)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 37205-278-10	1 in 1 CARTON	02/10/2012
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	02/10/2012

Labeler - CARDINAL HEALTH (097537435)