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Hydrocortisone by Sion Biotext Medical Ltd

Medically reviewed on March 15, 2017

Dosage form: cream
Ingredients: HYDROCORTISONE ACETATE 1g in 100g
Labeler: Sion Biotext Medical Ltd
NDC Code: 68786-224

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 1%

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

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

HYDROCORTISONE  
hydrocortisone acetate cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68786-224
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
HYDROCORTISONE ACETATE (HYDROCORTISONE) HYDROCORTISONE ACETATE1 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
PROPYLENE GLYCOL 
WATER 
CETETH-20 
CETOSTEARYL ALCOHOL 
CHLOROCRESOL 
EDETATE DISODIUM 
MINERAL OIL 
SODIUM METABISULFITE 
LIGHT MINERAL OIL 
Packaging
#Item CodePackage Description
1NDC:68786-224-0672 TUBE in 1 CASE
128.3 g in 1 TUBE
2NDC:68786-224-051728 PACKET in 1 CASE
20.5 g in 1 PACKET
3NDC:68786-224-0212 BOX in 1 CASE
3144 PACKET in 1 BOX
30.9 g in 1 PACKET
4NDC:68786-224-031728 PACKET in 1 CASE
40.9 g in 1 PACKET
5NDC:68786-224-0412 BOX in 1 CASE
5144 PACKET in 1 BOX
50.5 g in 1 PACKET
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34807/06/2012
Labeler - Sion Biotext Medical Ltd (532775194)
Establishment
NameAddressID/FEIOperations
Sion Biotext Medical Ltd532775194manufacture(68786-224)

 
Sion Biotext Medical Ltd

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Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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