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.

----------

Dynarex Hydrocortisone Cream 1%

Active ingredient                                  Purpose

Hydrocortisone 1%                              Antipruritic (anti-itch)

Warnings

​For external use only

Purpose

Uses: For temporary relief of itching associated with minor skin irritations, inflammation, and rashes due to, eczema, insect bites, poison ivy, poison oak, poison sumac, soaps, detergents, cosmetics, jewelry, seborrheic dermatitis, psoriasis and external genital, feminine, and anal itching.

Do Not Use:

Stop use and ask a doctor if:

Keep Out Of Reach of Children

Directions:

Adults and children 2 years of age and older:

Inactive ingredients:

Cetostearyl alcohol, glyceryl monostearate, methylchloroisothiazolinone, propylene glycol, purified water, stearic acid, trolamine, white soft paraffin 

Other information:

For temporary relief of minor skin irritations and external itching.

Principal Display Panel

Dynarex Hydrocortisone Items 1137 and 1139

Hydro 1139.jpg

Hydrocortisone 1137 - 1139

HYDROCORTISONE 
hydrocortisone cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:67777-417
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)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
PARAFFIN (UNII: I9O0E3H2ZE)  
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN)  
TROLAMINE (UNII: 9O3K93S3TK)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:67777-417-0128.4 g in 1 TUBE; Type 0: Not a Combination Product10/07/2016
2NDC:67777-417-020.9 g in 1 PACKET; Type 0: Not a Combination Product10/07/2016
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34810/07/2016
Labeler - Dynarex Corporation (008124539)
Registrant - Dynarex Corporation (008124539)
Establishment
NameAddressID/FEIBusiness Operations
Gopaldas Visram & Co.,Ltd858030888manufacture(67777-417)

Revised: 6/2017
Document Id: 70741340-4218-42e7-a74b-b44c182e413a
Set id: af0c5674-0827-46af-9268-3b8c3b10a783
Version: 4
Effective Time: 20170623
 
Dynarex Corporation