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HYDROCORTISONE ACETATE by Kinray Inc.

Medically reviewed on May 7, 2018

Dosage form: cream
Ingredients: HYDROCORTISONE ACETATE 1g in 100g
Labeler: Kinray Inc.
NDC Code: 63777-224

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.

Hydrocortisone

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

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HYDROCORTISONE ACETATE 
hydrocortisone acetate cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63777-224
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
CETETH-20 
CETOSTEARYL ALCOHOL 
CHLOROCRESOL 
EDETATE DISODIUM 
SODIUM METABISULFITE 
LIGHT MINERAL OIL 
PETROLATUM 
WATER 
PROPYLENE GLYCOL 
Packaging
#Item CodePackage Description
1NDC:63777-224-0128.4 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34807/29/2011
Labeler - Kinray Inc. (012574513)
Registrant - Dynarerx Corporation (008124539)
Establishment
NameAddressID/FEIOperations
Galentic Pharma (India) Pvt. Ltd.864201135manufacture(63777-224)
Establishment
NameAddressID/FEIOperations
Blossom Pharmaceuticals677381470manufacture(63777-224)

 
Kinray Inc.

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Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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