HYDROCORTISONE (antipruritic- anti-itch cream

Hydrocortisone by

Drug Labeling and Warnings

Hydrocortisone by is a Otc medication manufactured, distributed, or labeled by BluePoint Laboratories, Gopaldas Visram & Co., Ltd. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active Ingredient

Hydrocortisone USP 1%

Purpose

Antipruritic (Anti-Itch)

Uses

For temporary relief of itching associated with minor skin irritations, inflammation, and rashes due to eczema, insect bites, poison ivy, poison oak, poison sumac, soaps, detergents, cosmetics, jewelry, seborrheic dermatitis, psoriasis, and for external genital, feminine, and anal itching.

Warnings

For external use only

If pregnant or breast-feeding,

ask a health professional before use

Do not use

• in the eyes
• for diaper rash
• for external genital or feminine itching if you have a vaginal discharge
• more than the recommended daily dosage unless directed by a doctor
• this product in the rectum by using fingers or any mechanical device or applicator

Ask a doctor before use if you are using any other hydrocortisone product

Stop use and ask a doctor if

• Condition worsens, or if symptoms persist for more than 7 days or clear up and occur again within a few days, and do not continue to use this or any other hydrocortisone product
• in case of bleeding when used for anal itching

Keep out of reach of children

If swallowed, get medical help or contact a Poison Control Center right away.

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: consult a doctor.
• When used for anal itching, cleanse the affected area with mild soap and warm water and rinse thoroughly. Gently dry, patting or blotting with bathroom tissue or soft cloth before applying.
• Children under 12: consult a doctor before using for anal itching.

Other Information

• Do not use if seal on the tube is damaged or is not visible. To open, unscrew cap, pull tab to remove foil seal
• Store at room temperature
• Avoid excessive heat
• Preserve in well-closed container
• See crimp of tube or carton for Lot Number and Expiry Date

Inactive Ingredients

Cetostearyl Alcohol, Glyceryl Monostearate SE, Methylchloroisothiazolinone, Propylene Glycol, Purified Water, Stearic Acid, Trolamine, White Petrolatum

Questions?

Contact 1-800-707-4621

Manufactured in India by:

Gopaldas Visram & Company Limited

Plot No. A327, T.T.C Indl. Area, M.L.D.C

Mahape, Navi Mumbai - 400710.

Mfg. Lic. No.: KD/503

For BluePoint Laboratories

Rev 10/2021

Label

Hydrocortisone Cream, USP 1%

PRINCIPAL DISPLAY PANEL

Hydrocortisone Cream, USP 1%

PRINCIPAL DISPLAY PANEL

Hydrocortisone Cream, USP 1% Jar

INGREDIENTS AND APPEARANCE

HYDROCORTISONE 
antipruritic (anti-itch) cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 68001-476
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
HYDROCORTISONE (UNII: WI4X0X7BPJ) (HYDROCORTISONE - UNII:WI4X0X7BPJ)	HYDROCORTISONE	1 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
WHITE PETROLATUM (UNII: B6E5W8RQJ4)
STEARIC ACID (UNII: 4ELV7Z65AP)
TROLAMINE (UNII: 9O3K93S3TK)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
WATER (UNII: 059QF0KO0R)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
GLYCERYL STEARATE SE (UNII: FCZ5MH785I)
METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 68001-476-46	1 in 1 CARTON	11/27/2020
1		30 g in 1 TUBE; Type 0: Not a Combination Product
2	NDC: 68001-476-50	454 g in 1 JAR; Type 0: Not a Combination Product	11/27/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M017	11/27/2020

Labeler - BluePoint Laboratories (985523874)

Establishment
Name	Address	ID/FEI	Business Operations
Gopaldas Visram & Co., Ltd		858030888	manufacture(68001-476)