CORTISIL MDX- hydrocortisone acetate gel 
BioZone Laboratories,Inc.

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.

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Drug Facts

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

When using this product

Stop use and ask a doctor if

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 Type HUMAN OTC DRUG Item Code (Source) NDC:55379-406
Route of Administration TOPICAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
HYDROCORTISONE ACETATE (UNII: 3X7931PO74) (HYDROCORTISONE - UNII:WI4X0X7BPJ) HYDROCORTISONE ACETATE 1 g  in 100 g
Inactive Ingredients
Ingredient Name Strength
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
CYCLOMETHICONE (UNII: NMQ347994Z)  
PEG-12 GLYCERYL DIMYRISTATE (UNII: VS4W16AQ3X)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:55379-406-01 1 in 1 CARTON
1 30 g in 1 BOTTLE, PUMP
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph final part348 03/25/2013
Labeler - BioZone Laboratories,Inc. (555564293)

Revised: 3/2013
Document Id: 008a5dc6-136b-4809-bec6-0a7ecf1f3981
Set id: 008a5dc6-136b-4809-bec6-0a7ecf1f3981
Version: 1
Effective Time: 20130301
 
BioZone Laboratories,Inc.