Label: CORTISIL MDX- hydrocortisone acetate gel
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Contains inactivated NDC Code(s)
NDC Code(s): 55379-406-01 - Packager: BioZone Laboratories,Inc.
- Category: HUMAN OTC DRUG LABEL
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.
Drug Label Information
Updated March 1, 2013
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- Official Label (Printer Friendly)
- 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
- Other information
- INDICATIONS & USAGE
- Inactive ingredients
- Questions?
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PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
NET WT. 30G NDC 55379-406-01
CortiSILTMMDX
HYDROCORTISONE ACETATE 1% GELCONTAINS:
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 LLCDistributed By:
Moko Therapeutics LLC
Carlsbad, CA 92011 -
INGREDIENTS AND APPEARANCE
CORTISIL MDX
hydrocortisone acetate gelProduct 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)