Hydrocortisone by Galentic Pharma (India) Private Limited HYDROCORTISONE cream

Hydrocortisone by

Drug Labeling and Warnings

Hydrocortisone by is a Otc medication manufactured, distributed, or labeled by Galentic Pharma (India) Private Limited. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

SPL UNCLASSIFIED SECTION

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

Gandhidham-370 230, Gujarat. 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)

INGREDIENTS AND APPEARANCE

HYDROCORTISONE 
hydrocortisone cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 50382-024
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
HYDROCORTISONE (UNII: WI4X0X7BPJ) (HYDROCORTISONE - UNII:WI4X0X7BPJ)	HYDROCORTISONE	10 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 50382-024-11	144 in 1 CARTON	04/27/2016
1		0.9 g in 1 PACKET; Type 0: Not a Combination Product
2	NDC: 50382-024-13	1 in 1 CARTON	08/07/2013
2		28 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	08/07/2013

Labeler - Galentic Pharma (India) Private Limited (915110464)

Establishment
Name	Address	ID/FEI	Business Operations
Galentic Pharma (India) Private Limited		650970176	analysis(50382-024) , manufacture(50382-024) , pack(50382-024) , repack(50382-024) , sterilize(50382-024)