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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Dynarex Hydrocortisone Cream 1%

Active ingredient                                  Purpose

Hydrocortisone 1%                              Antipruritic (anti-itch)

Warnings

​For external use only

Purpose

For temporary relief of:

Itches and rashes due to:

and for external itching of:

Do Not Use:

Stop use and ask a physician if:

Keep Out Of Reach of Children

Directions:

Adults and children 2 years of age:

Children under 2 years of age:

Adults:

Inactive ingredients:

Cetomacrogol 1000, cetostearyl alcohol, chlorocresol, edetate disodium, liquid paraffin, propylene glycol, sodium betabisulphate, white soft paraffin, water (purified)

Other information:

For temporary relief of minor skin irritations and external itching.

Principal Display Panel

Dynarex Hydrocortisone Items 1137 and 1139

Hydro1139.jpg

Hydrocortisone 1137 - 1139

HYDROCORTISONE 
hydrocortisone cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:67777-415
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
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
WATER (UNII: 059QF0KO0R)  
ceteth-20 (UNII: I835H2IHHX)  
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
MINERAL OIL (UNII: T5L8T28FGP)  
SODIUM METABISULFITE (UNII: 4VON5FNS3C)  
PETROLATUM (UNII: 4T6H12BN9U)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:67777-415-0128.4 g in 1 TUBE; Type 0: Not a Combination Product12/02/2015
2NDC:67777-415-020.9 g in 1 PACKET; Type 0: Not a Combination Product12/02/2015
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34812/02/2015
Labeler - Dynarex Corporation (008124539)
Registrant - Dynarex Corporation (008124539)
Establishment
NameAddressID/FEIBusiness Operations
Galentic Pharma (India) Pvt. Ltd.650970176manufacture(67777-415)

Revised: 5/2016
Document Id: e9cb7007-906b-48bb-8548-e75d5773715c
Set id: d1db4d7c-c4d1-49de-be63-a2151a821258
Version: 2
Effective Time: 20160504
 
Dynarex Corporation