Label: CORTISIL MDX- hydrocortisone acetate gel

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph 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 1, 2013

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  • ACTIVE INGREDIENT

    Active ingredient
    Hydrocortisone Acetate 1.0%    		Purpose
    Anti-Pruritic
  • Use

    For the temporary relief of itching associated with minor skin irritations, inflammation and rashes.

  • Warnings

    For external use only

  • Do not use

    • hydrocortisone product unless you have consulted a doctor.
    • on children under 2 years of age.
    • on mucous membranes
  • When using this product

    • avoid contact with the eyes.
    • If irritation develops, topical corticosteroids should be discontinued and appropriate therapy instituted.
  • Stop use and ask a doctor if

    • condition worsens
    • 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 immediately.

  • Directions

    Adults and children 2 years of age and older: Apply to the affected area not more than 3 to 4 times daily. Children under 2 year of age: consult a doctor.

  • Other information

    Store at 15° to 30° C (59° to 86°F)

    Carton: 1oz applicator pump

  • INDICATIONS & USAGE

  • Inactive ingredients

    Cyclopentasiloxane, Dimethicone Crosspolymer, Cyclomethicone, PEG-12 Glyceryl Dimyristate, Disodium EDTA.

  • Questions?

    call 1-760-734-3622

  • PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

    NET WT. 30G          NDC 55379-406-01

    CortiSILTMMDX
    HYDROCORTISONE ACETATE 1% GEL

    CONTAINS:
    HYDROCORTISONE ACETATE 1% GEL
    IN A NON-AQUEOUS SILICONE
    AND SILICONE-CROSS POLYMER BASE.

    FOR EXTERNAL USE ONLY

    Store: Room Temperature

    US Patents: Pending

    MOKO
    THERAPEUTICS LLC

    Distributed By:
    Moko Therapeutics LLC
    Carlsbad, CA 92011

    Inner Package

  • INGREDIENTS AND APPEARANCE
    CORTISIL MDX 
    hydrocortisone acetate gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55379-406
    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
    CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    CYCLOMETHICONE (UNII: NMQ347994Z)  
    PEG-12 GLYCERYL DIMYRISTATE (UNII: VS4W16AQ3X)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:55379-406-011 in 1 CARTON
    130 g in 1 BOTTLE, PUMP
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34803/25/2013
    Labeler - BioZone Laboratories,Inc. (555564293)
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