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

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Leader Anti-Itch Cream 1 oz. NBE Benadryl Maximum Strength

Active ingredients                                                                             Purpose

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

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

Uses

temporarily relieves pain and itching associated with

Dries the oozing and weeping of poison ivy, poison oak and poison sumac

Warnings

For external use only.

Do not use

Ask a doctor before use

When using this product

Stop use and ask a doctor if

Keep out of reach of children.

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

Directions

Other information

Inactive ingredients

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

DISTRIBUTED BY CARDINAL HEALTH

DULIN, OHIO 43017

CIN 2372134

www.myleader.com

1-800-200-6313

image of carton labelEnter section text here

LEADER ANTI ITCH MAXIMUM STRENGTH 
diphenhydramine hydrochloride, zinc acetate cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:37205-278
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M) DIPHENHYDRAMINE HYDROCHLORIDE2 g  in 100 g
ZINC ACETATE (UNII: FM5526K07A) (ZINC CATION - UNII:13S1S8SF37) ZINC ACETATE0.1 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
CETYL ALCOHOL (UNII: 936JST6JCN)  
DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:37205-278-101 in 1 CARTON02/10/2012
128 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34802/10/2012
Labeler - CARDINAL HEALTH (097537435)

Revised: 12/2017
Document Id: 601af339-4d49-e38c-e053-2991aa0a9f00
Set id: c8bff831-706b-4430-9dae-11084e5928a7
Version: 2
Effective Time: 20171211
 
CARDINAL HEALTH