HYDROCORTISONE ACETATE ointment

HYDROCORTISONE ACETATE by

Drug Labeling and Warnings

HYDROCORTISONE ACETATE by is a Otc medication manufactured, distributed, or labeled by Galentic Pharma (India) Private Limited. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active Ingredient                            Purpose

Hydrocortisone Acetate 1%            Antipruritic (anti-itch)

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

Warnings:

For external use only

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:

Liquid Paraffin, White Soft Paraffin

Principal Display Panel

Hydrocortisone

Gal Hydro Ointment.jpg

INGREDIENTS AND APPEARANCE

HYDROCORTISONE ACETATE 
hydrocortisone acetate ointment

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 50382-007
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
PARAFFIN (UNII: I9O0E3H2ZE)
LIGHT MINERAL OIL (UNII: N6K5787QVP)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 50382-007-01	28.4 g in 1 TUBE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	09/06/2011

Labeler - Galentic Pharma (India) Private Limited (918531450)