Your browser does not support JavaScript! CORTISIL MDX (HYDROCORTISONE ACETATE) GEL [BIOZONE LABORATORIES,INC.]
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CORTISIL MDX (hydrocortisone acetate) gel
[BioZone Laboratories,Inc.]


Category DEA Schedule Marketing Status
HUMAN OTC DRUG LABEL OTC monograph final
NOTE: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 Sections

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

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

CORTISIL MDX 
hydrocortisone acetate gel
Product Information
Product TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:55379-406
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
CYCLOMETHICONE 5 
DIMETHICONE 
CYCLOMETHICONE 
PEG-12 GLYCERYL DIMYRISTATE 
EDETATE DISODIUM 
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)

Revised: 3/2013
 
BioZone Laboratories,Inc.

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