MICONAZOLE NITRATE 2% CREAM ANTIFUNGAL- miconazole nitrate cream

MICONAZOLE Nitrate 2% Cream ANTIFUNGAL by

Drug Labeling and Warnings

MICONAZOLE Nitrate 2% Cream ANTIFUNGAL by is a Otc medication manufactured, distributed, or labeled by Trifecta Pharmaceuticals Usa Llc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active ingredient

Miconazole Nitrate 2%

Purpose

Anti-Fungal

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center immediately.

Uses

• proven clinically effective in the treatment of most athlete's foot (tinea pedis), jock itch (tinea crurus), and ringworm (tinea capitis)
• relieves itching, scaling, cracking, burning and discomfort associated with these conditions.

Warnings

For external use only. Do not use if the safety-sealed tube is punctured or damaged.

Do not use on children under 2 years of age unless directed by a healthcare professional. When using this product avoid contact with the eyes.

Stop use and ask a healthcare professional if  irritation occurs or if there is no improvement within 4 weeks (for athlete's foot and ringworm)  Irritation occurs, or if there is no improvement within 2 weeks (for jock itch).

Directions

Clean the affected area and dry thoroughly  Apply a thin layer of the product over affected area twice daily (morning and night) or as directed by a healthcare professional  Supervise children in the use of this product.

For athlete's foot:  Use daily for 4 weeks. If condition persists, consult a healthcare professional.  Pay special attention to the spaces between the toes  Wear well fitting, ventilated shoes  Change socks atleast once daily.

For ringworm: Use daily for 4 weeks. If condition persists, consult a healthcare professional.

For jock itch: Use daily for 2 weeks. If condition persists longer, consult a healthcare professional.

This product is not effective on the scalp or nails.

INACTIVE INGREDIENT

Inactive ingredients Carbomer, cetostearyl alcohol, dimethyl sulfoxide, edetate disodium, ethylparaben, glycerol, glyceryl distearate, mineral oil, peregal-o, purified water, stearic acid, triethanolamine, petrolatum.

Other Information

Store at 15° - 30° c (59° - 86° f)  Lot number and expiration date see crimp of tube or see box.  To open: Unscrew cap, tear safety seal off.

You may report serious side effects to: QC@trifecta-pharma.com

SPL UNCLASSIFIED SECTION

FAST RELIEF 100% GUARANTEED

Relieves Itching and Burning

Also Cures Athlete's Foot and Ringworm

Distributed by:
Trifecta Pharmaceuticals USA TM
101 NE Third Avenue Suite 1500
Ft. Lauderdale, FL 33301 USA
www.trifecta-pharma.com

Packaging

INGREDIENTS AND APPEARANCE

MICONAZOLE NITRATE 2% CREAM ANTIFUNGAL 
miconazole nitrate cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69396-014
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MICONAZOLE NITRATE (UNII: VW4H1CYW1K) (MICONAZOLE - UNII:7NNO0D7S5M)	MICONAZOLE NITRATE	2 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
CARBOXYPOLYMETHYLENE (UNII: 0A5MM307FC)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
DIMETHYL SULFOXIDE (UNII: YOW8V9698H)
EDETATE DISODIUM (UNII: 7FLD91C86K)
ETHYLPARABEN (UNII: 14255EXE39)
GLYCERIN (UNII: PDC6A3C0OX)
GLYCERYL DISTEARATE (UNII: 73071MW2KM)
MINERAL OIL (UNII: T5L8T28FGP)
POLYOXYL 20 CETOSTEARYL ETHER (UNII: YRC528SWUY)
WATER (UNII: 059QF0KO0R)
STEARIC ACID (UNII: 4ELV7Z65AP)
TROLAMINE (UNII: 9O3K93S3TK)
PETROLATUM (UNII: 4T6H12BN9U)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69396-014-20	1 in 1 BOX	03/22/2016
1		30 g in 1 TUBE; Type 0: Not a Combination Product
2	NDC: 69396-014-05	15 g in 1 TUBE; Type 0: Not a Combination Product	03/22/2016

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part333C	03/22/2016

Labeler - Trifecta Pharmaceuticals Usa Llc (079424163)