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  5. Label Information: Cortisil Mdx

FDA Label for Cortisil Mdx

View Indications, Usage & Precautions

Table of Contents

    1. OTC - ACTIVE INGREDIENT
    2. USE
    3. WARNINGS
    4. DO NOT USE
    5. WHEN USING THIS PRODUCT
    6. STOP USE AND ASK A DOCTOR IF
    7. KEEP OUT OF REACH OF CHILDREN.
    8. DIRECTIONS
    9. OTHER INFORMATION
    10. INACTIVE INGREDIENTS
    11. QUESTIONS?
    12. PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Cortisil Mdx Product Label

The following document was submitted to the FDA by the labeler of this product Biozone Laboratories,inc.. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

Otc - 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


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 - 008a5dc6 136b 4809 bec6 0a7ecf1f3981 01

Inner Package - 008a5dc6 136b 4809 bec6 0a7ecf1f3981 01


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