HYDROCORTISONE ACETATE description, usages, side effects, indications, overdosage, supplying and lots more!

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HYDROCORTISONE ACETATE

Galentic Pharma (India) Private Limited

Galentic Hydrocortisone Ointment 1%


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

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

HYDROCORTISONE ACETATE

HYDROCORTISONE ACETATE

Hydrocortisone Acetate OINTMENT

Product Information

Product Type Human otc drug label Item Code (Source) NDC:50382-007
Route of Administration TOPICAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
HYDROCORTISONE ACETATE HYDROCORTISONE 1 g

Inactive Ingredients

Ingredient Name Strength
PARAFFIN
LIGHT MINERAL OIL

Packaging

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

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
part part348 2011-09-06


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Be sure to consult your doctor before taking any medication!
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