HYDROCORTISONE- hydrocortisone cream

Hydrocortisone by

Drug Labeling and Warnings

Hydrocortisone by is a Otc medication manufactured, distributed, or labeled by Sion Biotext Medical Ltd. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredient (In Each Gram)

Hydrocortisone 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 sumar
• detergents
• cosmetics
• jewelry
• seborrheic dermatitis
• psoriasis

and for external genital, feminine and anal itching

Warnings:

FOR EXTERNAL USE ONLY

​If pregnant or breastfeeding, 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 other mechanical device or applicator

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 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 or 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 waterand risne 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:

• store at 15o - 30oC (59o - 86oF)
• avoid excessive heat and humidity

Inactive Ingredients:

Cetostearyl Alcohol,Glyceryl Monostearate SE, Methylchloroisothiazolinone, Propylene Glycol, Purified Water, Stearic Acid, Triethanolamine, White Soft Paraffin

Distributed by

​SIONBRANDS, INC. ​754 Roble Rd, Suite 180, Allentown, PA, 18109, USA.

Principal Display Panel

NDC # 68786-223-01

SiON BiOTEXT

For Personal and Professional Use

Hydrocortisone Cream 1%

Relief of Minor Skin Irritation, Itching and Rashes

Net Wt: 1.0 oz (28.3 g)

INGREDIENTS AND APPEARANCE

HYDROCORTISONE  
hydrocortisone cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 68786-223
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
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
WATER (UNII: 059QF0KO0R)
STEARIC ACID (UNII: 4ELV7Z65AP)
TROLAMINE (UNII: 9O3K93S3TK)
PETROLATUM (UNII: 4T6H12BN9U)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 68786-223-01	28.3 g in 1 TUBE; Type 0: Not a Combination Product	01/31/2019

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	01/31/2019

Labeler - Sion Biotext Medical Ltd (532775194)

Establishment
Name	Address	ID/FEI	Business Operations
Sion Biotext Medical Ltd		532775194	manufacture(68786-223)