Cortisil Mdx
FDA Label NDC 55379-406

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Biozone Laboratories,inc. for the product Cortisil Mdx (NDC 55379-406). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding otc - active ingredient, use, warnings, do not use, when using this product, stop use and ask a doctor if, keep out of reach of children., directions, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

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)

* Please review the disclaimer below.