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Hydrocortisone by Galentic Pharma (India) Private Limited

Medically reviewed on January 18, 2018

Dosage form: cream
Ingredients: Hydrocortisone 10mg in 1g
Labeler: Galentic Pharma (India) Private Limited
NDC Code: 50382-024

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 CREAM

• ACTIVE INGREDIENT

Hydrocortisone 1%

• PURPOSE

Anti-Itch

• USES

Temporarily relieves itching associated with minor skin irritations, inflammation, and rashes due to:

  • eczema
  • psoriasis
  • poison ivy, poison oak, poison sumac
  • insect bites
  • detergents
  • jewelry
  • seborrheic dermatitis
  • soaps
  • external itching and anal itching.

• WARNINGS

For external use only

Do not use
  • For the treatment of diaper rash. Ask a doctor
  • For external genital itching if you have a vaginal discharge. Ask a doctor

When using this product
  • Avoid contact with the eyes
  • Do not begin use of any other Hydrocortisone product unless you have asked a doctor
  • For external anal itching do not exceed the recommended daily dosage unless directed by a doctor. In case of bleeding, consult a doctor promptly.
  • Do not put this product into the rectum by using fingers or any mechanical device or applicator

• Stop use and ask a doctor if
  • Condition worsens
  • Symptoms persist for more than 7 days or clear up and occur again within a few days

• KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center immediately.

• DIRECTIONS

Adults and children 2 years of age and older:

  • apply to affected area not more than 3 to 4 times daily.

Children under 2 years of age:

  • do not use. Ask a doctor.

For external anal itching:

  • adults: when practical, cleanse the affected area with mild soap and warm water and rinse thoroughly. Gently dry by patting or blotting with toilet tissue or a soft cloth before application of this product.
  • children under 12 years of age with external anal itching: ask a doctor.

• OTHER INFORMATION
  • Store at 15° to 30°C (59° to 86°F)
  • Lot No. & Exp.Date: See box or crimp of tube.

• INACTIVE INGREDIENT

Cetamacrogol 1000, Cetostearyl Alcohol, Chlorocresol, Liquid Paraffin, Propylene Glycol, Purified Water, White Soft Paraffin

Manufactured by : Galentic Pharma (India) Pvt. Ltd., Plot No. 5-B & 5-C, Sector III, Kandla Special Economic Zone,
Gandhidham-370 230, Gujrat. India

PRINCIPAL DISPLAY PANEL - 28 g Tube Carton

Galentic

1%Hydrocortisone
Cream
MAXIMUM STRENGTH

Relieves ITCHING and REDNESS fast
Helps heal rashes for healthier skin

NET WT.
1 OZ. (28g)

HYDROCORTISONE 
hydrocortisone cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50382-024
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Hydrocortisone (Hydrocortisone) Hydrocortisone10 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
Ceteth-20 
Cetostearyl Alcohol 
Mineral Oil 
Chlorocresol 
Propylene Glycol 
Water 
Petrolatum 
Packaging
#Item CodePackage Description
1NDC:50382-024-11144 PACKET in 1 CARTON
10.9 g in 1 PACKET
2NDC:50382-024-131 TUBE in 1 CARTON
228 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart34808/07/2013
Labeler - Galentic Pharma (India) Private Limited (915110464)
Establishment
NameAddressID/FEIOperations
Galentic Pharma (India) Private Limited864201135ANALYSIS(50382-024), MANUFACTURE(50382-024), PACK(50382-024), REPACK(50382-024), STERILIZE(50382-024)
Establishment
NameAddressID/FEIOperations
Galentic Pharma (India) Private Limited650970176ANALYSIS(50382-024), MANUFACTURE(50382-024), PACK(50382-024), REPACK(50382-024), STERILIZE(50382-024)

 
Galentic Pharma (India) Private Limited

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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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