HYDROCORTISONE- hydrocortisone cream 
Kinray Inc.

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 1%            Antipruritic (anti-itch)

Warnings:

For external use only

Purpose

Hydrocortisone is for temporary relief of;


minor skin irritations
Itching and rashes due to;
eczema
insect bites
poison ivy
poison oak
poison sumac
soaps
detergents
cosmetics
jewelry

and for external itching of;
genital
feminine and
anal itching

Indications and Usage

Stop use and ask a physician if:

Keep out of reach of children

Dosage and Administration

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

Other information:

Inactive Ingredients

Inactive Ingredients: Cetostearyl alcohol, glyceryl monostearate, mrthylchloroisothiazolinone, propylene glycol, purified water, stearic acid, triethanolamine, white soft paraffin.

Principal Display Panel

KR-1139

Hydrocortisone248.jpg

Hydrocortisone

HYDROCORTISONE 
hydrocortisone cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63777-248
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
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN)  
PARAFFIN (UNII: I9O0E3H2ZE)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
WATER (UNII: 059QF0KO0R)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
TROLAMINE (UNII: 9O3K93S3TK)  
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:63777-248-0128.4 g in 1 TUBE; Type 0: Not a Combination Product06/14/2017
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34806/14/2017
Labeler - Kinray Inc. (012574513)
Registrant - Dynarerx Corporation (008124539)

Revised: 6/2017
Document Id: 51d10220-2878-43f3-bce0-d9e473ef8060
Set id: 2b36f50b-2ca9-4c52-a6fa-a9d70851d80e
Version: 1
Effective Time: 20170614
 
Kinray Inc.