MICONAZOLE NITRATE 2% CREAM ANTIFUNGAL- miconazole nitrate cream 
Trifecta Pharmaceuticals Usa Llc

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MICONAZOLE Nitrate 2% Cream ANTIFUNGAL

Drug Facts

Active ingredient

Miconazole Nitrate 2%

Purpose

Anti-Fungal

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

Uses

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 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

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

Miconazole new

Package Label

77012-FBA GLOBE MICONAZOLE NITRATE CREAM 1OZ 3PK_BOX 061224 CDER

MICONAZOLE NITRATE 2% CREAM ANTIFUNGAL 
miconazole nitrate cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69396-014
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MICONAZOLE NITRATE (UNII: VW4H1CYW1K) (MICONAZOLE - UNII:7NNO0D7S5M) MICONAZOLE NITRATE2 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:69396-014-201 in 1 BOX03/22/2016
130 g in 1 TUBE; Type 0: Not a Combination Product
2NDC:69396-014-0515 g in 1 TUBE; Type 0: Not a Combination Product03/22/2016
3NDC:69396-014-04118.3 g in 1 TUBE; Type 0: Not a Combination Product09/23/2022
4NDC:69396-014-444 in 1 BOX02/29/2024
430 g in 1 TUBE; Type 0: Not a Combination Product
5NDC:69396-014-333 in 1 BOX03/22/2024
530 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM00503/22/2016
Labeler - Trifecta Pharmaceuticals Usa Llc (079424163)

Revised: 6/2024
Document Id: 1ace1bf8-7f7d-9141-e063-6294a90a1be0
Set id: 80217dbb-a0f0-414a-8d22-a9a346b017aa
Version: 12
Effective Time: 20240613
 
Trifecta Pharmaceuticals Usa Llc