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HYDROCORTISONE ACETATE by Galentic Pharma (India) Private Limited

Dosage form: ointment
Ingredients: HYDROCORTISONE ACETATE 1g in 100g
Labeler: Galentic Pharma (India) Private Limited
NDC Code: 50382-007

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.

Galentic Hydrocortisone Ointment 1%

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 ointment
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50382-007
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
HYDROCORTISONE ACETATE (HYDROCORTISONE) HYDROCORTISONE ACETATE1 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
PARAFFIN 
LIGHT MINERAL OIL 
Packaging
#Item CodePackage Description
1NDC:50382-007-0128.4 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34809/06/2011
Labeler - Galentic Pharma (India) Private Limited (918531450)

 
Galentic Pharma (India) Private Limited

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Medically reviewed on Aug 7, 2018

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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