HYDROCORTISONE- hydrocortisone acetate cream 
Sion Biotext Medical Ltd

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 20 o - 25 oC (68 o - 77 oF)
  • 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

Label

HYDROCORTISONE 
hydrocortisone acetate cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68786-224
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
HYDROCORTISONE ACETATE (UNII: 3X7931PO74) (HYDROCORTISONE - UNII:WI4X0X7BPJ) HYDROCORTISONE ACETATE1 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:68786-224-0672 in 1 CASE07/06/201212/31/2022
128.3 g in 1 TUBE; Type 0: Not a Combination Product
2NDC:68786-224-051728 in 1 CASE07/06/201212/31/2022
20.5 g in 1 PACKET; Type 0: Not a Combination Product
3NDC:68786-224-0212 in 1 CASE07/06/201212/31/2022
3144 in 1 BOX
30.9 g in 1 PACKET; Type 0: Not a Combination Product
4NDC:68786-224-031728 in 1 CASE07/06/201212/31/2022
40.9 g in 1 PACKET; Type 0: Not a Combination Product
5NDC:68786-224-0412 in 1 CASE07/06/201212/31/2022
5144 in 1 BOX
50.5 g in 1 PACKET; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34807/06/201212/31/2022
Labeler - Sion Biotext Medical Ltd (532775194)
Registrant - Sion Biotext Medical Ltd (532775194)
Establishment
NameAddressID/FEIBusiness Operations
Sion Biotext Medical Ltd532775194manufacture(68786-224)

Revised: 12/2022
 
Sion Biotext Medical Ltd