CORTISIL MDX- hydrocortisone acetate gel

CortiSil MDX by

Drug Labeling and Warnings

CortiSil MDX by is a Otc medication manufactured, distributed, or labeled by BioZone Laboratories,Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

INGREDIENTS AND APPEARANCE

CORTISIL MDX 
hydrocortisone acetate gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 55379-406
Route of Administration	TOPICAL

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)