HYDROCORTISONE- hydrocortisone acetate 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

Hydrocortisone Acetate, USP (1%  w/w)        

Purpose

Antipruritic (Anti-Itch)

Uses:

For temporary relief of;

• minor skin irritations

Itching and rashes due to;

• eczema
• insect bites
• poison ivy
• poison oak
• poison sumac
• soaps
• detergents
• cosmetics
• jewelry

and for external itching of;

•  genital
• feminine and
• anal itching

Other uses of this product should be under the advice and supervision of a doctor.

Warnings:

FOR EXTERNAL USE ONLY

Do not use:

• in the eyes
• for diaper rash
• if you have vaginal discharge
• more than the recommended daily dosage
  

Ask a doctor before use if

​you are pregnant or breast feeding

Stop use and ask a doctor if:

• the condition persists or gets worse or if,
• if symptoms persist for more than 7 days or clear up and occur again within a few days

Keep out of reach of children

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

Directions:

Adults and children over 2 years of age

• Apply evenly to affected area no more than 3 or 4 times daily.

Children under 2 years of age

• Do not use
• consult a physician

Adults

• When practical, cleanse the affected area with mild soap and warm water and rinse thoroughly
• Gently dry, patting and blotting with bathroom tissue or soft cloth before applying
• apply externally to the area up to 6 times daily or after each bowel movement
• After application, discard pad
• Do not flush in toilet
  

Other information:

• Store at 20o - 25oC (68o - 77oF)
• Avoid excessive heat and humidity

Inactive ingredients:

Cetostearyl Alcohol, Chlorocresol, CETETH-20, Edetate Disodium, Liquid Paraffin, Propylene Glycol, Purified Water, Sodium Betabisulphite, White Soft Paraffin

SPL UNCLASSIFIED SECTION

Sion Biotext Medical Ltd. Hagoshrim, 1222500, ISRAEL. Email: sales@sn-medical.com Tel: +972-4-6956201

www.sn-medical.com

Principal Display Panel

NDC # 68786-224-02

Sion Biotext Medical Ltd.

For Professional and Hospital Use

Hydrocortisone Cream 1%

Relief of Minor Skin Irritation, Itching and Rashes

Ref: 54C813-9401-000

Net Wt 0.9gram

144 Packets

INGREDIENTS AND APPEARANCE

HYDROCORTISONE  
hydrocortisone acetate cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 68786-224
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
HYDROCORTISONE ACETATE (UNII: 3X7931PO74) (HYDROCORTISONE - UNII:WI4X0X7BPJ)	HYDROCORTISONE ACETATE	1 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
WATER (UNII: 059QF0KO0R)
CETETH-20 (UNII: I835H2IHHX)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
CHLOROCRESOL (UNII: 36W53O7109)
EDETATE DISODIUM (UNII: 7FLD91C86K)
MINERAL OIL (UNII: T5L8T28FGP)
SODIUM METABISULFITE (UNII: 4VON5FNS3C)
LIGHT MINERAL OIL (UNII: N6K5787QVP)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 68786-224-06	72 in 1 CASE	07/06/2012
1		28.3 g in 1 TUBE; Type 0: Not a Combination Product
2	NDC: 68786-224-05	1728 in 1 CASE	07/06/2012
2		0.5 g in 1 PACKET; Type 0: Not a Combination Product
3	NDC: 68786-224-02	12 in 1 CASE	07/06/2012
3		144 in 1 BOX
3		0.9 g in 1 PACKET; Type 0: Not a Combination Product
4	NDC: 68786-224-03	1728 in 1 CASE	07/06/2012
4		0.9 g in 1 PACKET; Type 0: Not a Combination Product
5	NDC: 68786-224-04	12 in 1 CASE	07/06/2012
5		144 in 1 BOX
5		0.5 g in 1 PACKET; 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	07/06/2012

Labeler - Sion Biotext Medical Ltd (532775194)

Establishment
Name	Address	ID/FEI	Business Operations
Sion Biotext Medical Ltd		532775194	manufacture(68786-224)