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.

----------

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, 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)

PRINCIPAL DISPLAY PANEL - 28 g Tube Carton

HYDROCORTISONE
hydrocortisone cream

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

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

Ingredient Name	Strength
Inactive Ingredients
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)

#	Item Code	Package Description	Marketing Start Date
Packaging
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 Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part348	08/07/2013

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

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

Revised: 11/2022

Document Id: ee8665e4-eb23-2f51-e053-2995a90a8770

Set id: fca38e50-bb06-4b87-b201-f8fc01556d66

Version: 3

Effective Time: 20221128

Galentic Pharma (India) Private Limited