HYDROCORTISONE by Kinray Inc. / Dynarerx Corporation HYDROCORTISONE cream

HYDROCORTISONE by

Drug Labeling and Warnings

HYDROCORTISONE by is a Otc medication manufactured, distributed, or labeled by Kinray Inc., Dynarerx Corporation. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

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

• in the eyes
• longer than 1 week unless directed by a physician
• for diaper rash
• if you have vaginal discharge
• more than the recommended daily dosage unless directed by a doctor
• in the rectum bu using fingers or any other mechanical device or applicator
• For temporary relief of minor skin irritations and external itching.

Stop use and ask a physician if:

• the condition persists or gets worse
• symptoms clear up and occur again within a few days
• you are pregnant or breast feeding
  

Keep out of reach of children

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

Dosage and Administration

Adults and children over 2 years of age

• Apply evenly to affected area no more than 3 or 4 times daily.

Children under 2 years of age

• Do not use
• consult a physician

Adults

• When practical, cleanse the affected area with mild soap and warm water and rinse thoroughly
• Gently dry, patting and blotting with bathroom tissue or soft cloth before applying
• apply externally to the area up to 6 times daily or after each bowel movement
  

Other information:

• Store at 20 deg - 25 deg C (68 deg - 77 deg F)
• Avoid excessive heat and humidity
  

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

INGREDIENTS AND APPEARANCE

HYDROCORTISONE 
hydrocortisone cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 63777-248
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
HYDROCORTISONE (UNII: WI4X0X7BPJ) (HYDROCORTISONE - UNII:WI4X0X7BPJ)	HYDROCORTISONE	1 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 63777-248-01	28.4 g in 1 TUBE; Type 0: Not a Combination Product	06/14/2017

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	06/14/2017

Labeler - Kinray Inc. (012574513)

Registrant - Dynarerx Corporation (008124539)