HYDROCORTISONE - hydrocortisone  cream 
Dynarex Corporation

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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Hydrocortisone

Active Ingredient                            Purpose

Hydrocortisone USP 10 mg            Antipruritic (anti-itch)

Uses:

For temporary relief of;

and for external itching of;

Warnings:

For external use only

Do not use:

Stop use and ask a physician if:

Keep out of reach of children

Directions:

Adults and children over 2 years of age
Children under 2 years of age
Adults

Other information:

Inactive ingredients:

citric acid, glycerin, glycerol stearate, methylparaben, petrolatum, polysorbate 80, propyl paraben, propylene glycol, purified water, sodium citrate, titanium dioxide,

Indications and Usage

For temporary relief of minor skin irritations and external itching.

Principal Display

Hydrocortisone


HYDROCORTISONE 
hydrocortisone cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:67777-237
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
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
GLYCERIN (UNII: PDC6A3C0OX)  
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
PETROLATUM (UNII: 4T6H12BN9U)  
POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
SODIUM CITRATE (UNII: 1Q73Q2JULR)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
WATER (UNII: 059QF0KO0R)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:67777-237-0112 in 1 CASE
1144 in 1 BOX
10.9 g in 1 PACKET
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34802/02/2010
Labeler - Dynarex Corporation (008124539)
Registrant - Dynarex Corporation (008124539)

Revised: 3/2011
Document Id: 489256ed-4c2a-4ab5-9728-612498b677fa
Set id: 94355b6e-278e-49c0-8182-f6ceed695966
Version: 1
Effective Time: 20110315
 
Dynarex Corporation