DERMAFUNGAL- antimicrobial drug products cream

DERMAFUNGAL by

Drug Labeling and Warnings

DERMAFUNGAL by is a Otc medication manufactured, distributed, or labeled by DermaRite industries, LLC, Mark Friedman. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredient:

Miconazole Nitrate 2%

Purpose:

Antifungal

Uses:

• For the treatment and prevention of most: athlete's foot, jock itch, ringworm
• relieves itching, scaling,cracking, and discomfort associated with these conditions.

Warnings:

• For external use only.
• Avoid contact with eyes. In case of contact, flush thoroughly with water.
• Stop use and ask doctor if irritation occurs , condition worsens or does not improve in 2 weeks for jock itch, or within 4 weeks for athlete's foot and ringworm.

Warnings

• Keep out of reach of children. In case of accidental ingestion contact physician or Poison Control Center right away.

Directions

Cleanse affected area and dry thoroughly. Apply a thin layer to affected area twice daily or as directed by physician.

• For jockitch use daily for two weeks.
• For athelete's foot use daily for four weeks.

Other Information:

• This product is not effective on the scalp and nails.
• Store at room temperature (59°-86°F)

Inactive Ingredients:

Caprylic/Capric Triglyceride, Ceteareth-20, Disodium EDTA, Glyceryl Stearate, Methylparaben, PEG-40 Castor Oil, PEG-100 Stearate, Petrolatum, Propylene Glycol, Propylparaben, Stearic Acid, Water, Xantham Gum

Durmafungal Principal Display Panel and Drug Facts

INGREDIENTS AND APPEARANCE

DERMAFUNGAL 
antimicrobial drug products cream

Product 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)