Label: HYDROCORTISONE- hydrocortisone acetate cream

  • NDC Code(s): 68786-224-02, 68786-224-03, 68786-224-04, 68786-224-05, view more
    68786-224-06
  • Packager: Sion Biotext Medical Ltd
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not final

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.

Drug Label Information

Updated March 15, 2017

If you are a consumer or patient please visit this version.

  • 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

    Label

  • INGREDIENTS AND APPEARANCE
    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 CASE07/06/2012
    128.3 g in 1 TUBE; Type 0: Not a Combination Product
    2NDC:68786-224-051728 in 1 CASE07/06/2012
    20.5 g in 1 PACKET; Type 0: Not a Combination Product
    3NDC:68786-224-0212 in 1 CASE07/06/2012
    3144 in 1 BOX
    30.9 g in 1 PACKET; Type 0: Not a Combination Product
    4NDC:68786-224-031728 in 1 CASE07/06/2012
    40.9 g in 1 PACKET; Type 0: Not a Combination Product
    5NDC:68786-224-0412 in 1 CASE07/06/2012
    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 finalpart34807/06/2012
    Labeler - Sion Biotext Medical Ltd (532775194)
    Establishment
    NameAddressID/FEIBusiness Operations
    Sion Biotext Medical Ltd532775194manufacture(68786-224)