HYDROCORTISONE CREAM

HYDROCORTISONE CREAM

Drug Labeling and Warnings

Drug Details

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HYDROCORTISONE- hydrocortisone cream 
Galentic Pharma (India) Private Limited

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.

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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)

PRINCIPAL DISPLAY PANEL - 28 g Tube Carton
HYDROCORTISONE 
hydrocortisone cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 50382-024
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Hydrocortisone (UNII: WI4X0X7BPJ) (Hydrocortisone - UNII:WI4X0X7BPJ) Hydrocortisone10 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
Ceteth-20 (UNII: I835H2IHHX)  
Cetostearyl Alcohol (UNII: 2DMT128M1S)  
Mineral Oil (UNII: T5L8T28FGP)  
Chlorocresol (UNII: 36W53O7109)  
Propylene Glycol (UNII: 6DC9Q167V3)  
Water (UNII: 059QF0KO0R)  
Petrolatum (UNII: 4T6H12BN9U)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 50382-024-11144 in 1 CARTON04/27/2016
10.9 g in 1 PACKET; Type 0: Not a Combination Product
2NDC: 50382-024-131 in 1 CARTON08/07/2013
228 g in 1 TUBE; Type 0: Not a Combination Product
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/FEIBusiness Operations
Galentic Pharma (India) Private Limited864201135ANALYSIS(50382-024) , MANUFACTURE(50382-024) , PACK(50382-024) , REPACK(50382-024) , STERILIZE(50382-024)
Establishment
NameAddressID/FEIBusiness Operations
Galentic Pharma (India) Private Limited650970176ANALYSIS(50382-024) , MANUFACTURE(50382-024) , PACK(50382-024) , REPACK(50382-024) , STERILIZE(50382-024)

Revised: 1/2018
 
Galentic Pharma (India) Private Limited


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