LEADER HYDROCORTISONE - hydrocortisone 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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Active ingredient                                                                       Purpose

Hydrocortisone 1%....................................................................Anti-itch

Uses for the temporary relief of itching associated with minor skin irriations, inflammation and rashes due to:

Other uses or the use of the product for more than 7 days should be undertaken only under the advice and supervision of a doctor

Warnings

Stop using this product and ask a doctor

Do not use this product and ask a doctor

For external anal itching users:

Keep this and all drugs out of the reach of children.

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

Before using any medication, read all label directions.  Keep this carton.  It contains important information.

Directions

For external anal itching users

or a soft cloth before application of this product

Other information

Inactive ingredients

butylated hydroxytoluene, cetanol, liquid paraffin, methylparaben, polyoxyethylene cetylether, propylene glycol, propylparaben, purified water, sorbitan monostearate, stearyl alcohol

DISTRIBUTED BY

CARDINAL HEALTH, DUBLIN, OHIO 43017

www.myleader.com

1-800-200-6313

image description

LEADER HYDROCORTISONE  
hydrocortisone cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:37205-162
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
HYDROCORTISONE (UNII: WI4X0X7BPJ) (HYDROCORTISONE - UNII:WI4X0X7BPJ) HYDROCORTISONE1 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
CETYL ALCOHOL (UNII: 936JST6JCN)  
PARAFFIN (UNII: I9O0E3H2ZE)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
WATER (UNII: 059QF0KO0R)  
SORBITAN MONOSTEARATE (UNII: NVZ4I0H58X)  
STEARYL ALCOHOL (UNII: 2KR89I4H1Y)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:37205-162-101 in 1 CARTON10/11/2016
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 finalpart34802/13/2012
Labeler - CARDINAL HEALTH (097537435)

Revised: 7/2017
Document Id: ed973033-e46e-412a-aaee-9d3b7fad0c3c
Set id: ecf8d029-13bf-419c-b2fc-79d051d5f089
Version: 3
Effective Time: 20170724
 
CARDINAL HEALTH