NDC | 61924-234-04, 61924-234-05 |
Set ID | 4e7739a1-cff0-4b76-94f0-d9f9af158df5 |
Category | HUMAN OTC DRUG LABEL |
Packager | DermaRite industries, LLC |
Generic Name | |
Product Class | Azole Antifungal |
Product Number | |
Application Number | PART333C |
- Active Ingredient:
- Purpose:
- Uses:
- Warnings:
- Warnings
- Directions
- Other Information:
- Inactive Ingredients:
- Durmafungal Principal Display Panel and Drug Facts
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INGREDIENTS AND APPEARANCE
DERMAFUNGAL
antimicrobial drug products creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:61924-234 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength MICONAZOLE NITRATE (UNII: VW4H1CYW1K) (MICONAZOLE - UNII:7NNO0D7S5M) MICONAZOLE NITRATE 0.02 g in 100 g Inactive Ingredients Ingredient Name Strength MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U) POLYOXYL 20 CETOSTEARYL ETHER (UNII: YRC528SWUY) CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S) IMIDUREA (UNII: M629807ATL) DIMETHICONE (UNII: 92RU3N3Y1O) EDETATE DISODIUM (UNII: 7FLD91C86K) GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4) METHYLPARABEN (UNII: A2I8C7HI9T) PEG-40 CASTOR OIL (UNII: 4ERD2076EF) PEG-100 STEARATE (UNII: YD01N1999R) PETROLATUM (UNII: 4T6H12BN9U) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) PROPYLPARABEN (UNII: Z8IX2SC1OH) STEARIC ACID (UNII: 4ELV7Z65AP) WATER (UNII: 059QF0KO0R) XANTHAN GUM (UNII: TTV12P4NEE) Product Characteristics Color white Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:61924-234-05 5 g in 1 PACKET; Type 0: Not a Combination Product 12/12/2005 2 NDC:61924-234-04 106 g in 1 TUBE; Type 0: Not a Combination Product 12/12/2005 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part333C 12/12/2005 Labeler - DermaRite industries, LLC (883925562) Registrant - Mark Friedman (883925562) Establishment Name Address ID/FEI Business Operations DermaRite industries, LLC 883925562 manufacture(61924-234)