MICONAZOLE NITRATE 2% CREAM ANTIFUNGAL- miconazole nitrate cream 
RTMH Enterprises DBA Research Technology Medical Home

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.

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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

Fugeon Box label

MICONAZOLE NITRATE 2% CREAM ANTIFUNGAL 
miconazole nitrate cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72071-101
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
PETROLATUM (UNII: 4T6H12BN9U)  
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)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:72071-101-211 in 1 BOX09/28/2018
115 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart333C09/28/2018
Labeler - RTMH Enterprises DBA Research Technology Medical Home (042580344)
Registrant - RTMH Enterprises DBA Research Technology Medical Home (042580344)

Revised: 12/2022
Document Id: f0e79299-054d-af9d-e053-2a95a90a39d0
Set id: 76ee5b72-9ca3-5030-e053-2a91aa0a475f
Version: 5
Effective Time: 20221228
 
RTMH Enterprises DBA Research Technology Medical Home