HYDROCORTISONE ACETATE cream

HYDROCORTISONE ACETATE by

Drug Labeling and Warnings

HYDROCORTISONE ACETATE by is a Otc medication manufactured, distributed, or labeled by Kinray Inc., Dynarerx Corporation, Galentic Pharma (India) Pvt. Ltd., Blossom Pharmaceuticals. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active Ingredient                            Purpose

Hydrocortisone Acetate 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: Cetomacrogol 1000, Cetostearyl alcohol, Chlorocresol, Edetate sodium, Liquid paraffin, Propylene glycol, Purified water, Sodium metabisulphate, White soft paraffin.

Principal Display Panel

KR-1139

Hydrocortisone.jpg

INGREDIENTS AND APPEARANCE

HYDROCORTISONE ACETATE 
hydrocortisone acetate cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 63777-224
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
HYDROCORTISONE ACETATE (UNII: 3X7931PO74) (HYDROCORTISONE - UNII:WI4X0X7BPJ)	HYDROCORTISONE ACETATE	1 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
CETETH-20 (UNII: I835H2IHHX)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
CHLOROCRESOL (UNII: 36W53O7109)
EDETATE DISODIUM (UNII: 7FLD91C86K)
SODIUM METABISULFITE (UNII: 4VON5FNS3C)
LIGHT MINERAL OIL (UNII: N6K5787QVP)
PETROLATUM (UNII: 4T6H12BN9U)
WATER (UNII: 059QF0KO0R)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 63777-224-01	28.4 g in 1 TUBE; Type 0: Not a Combination Product	09/06/2011

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	07/29/2011

Labeler - Kinray Inc. (012574513)

Registrant - Dynarerx Corporation (008124539)

Establishment
Name	Address	ID/FEI	Business Operations
Galentic Pharma (India) Pvt. Ltd.		864201135	manufacture(63777-224)

Establishment
Name	Address	ID/FEI	Business Operations
Blossom Pharmaceuticals		677381470	manufacture(63777-224)