OTC Medication Information: MICONAZOLE Nitrate 2% Cream ANTIFUNGAL

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

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.

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

• 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 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 NITRATE 2% CREAM ANTIFUNGAL miconazole nitrate cream

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

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength MICONAZOLE NITRATE (MICONAZOLE) MICONAZOLE NITRATE 2 g in 100 g

Inactive Ingredients Ingredient Name Strength CARBOXYPOLYMETHYLENE CETOSTEARYL ALCOHOL DIMETHYL SULFOXIDE EDETATE DISODIUM ETHYLPARABEN GLYCERIN GLYCERYL DISTEARATE MINERAL OIL POLYOXYL 20 CETOSTEARYL ETHER WATER STEARIC ACID TROLAMINE PETROLATUM

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:69396-014-20 1 TUBE in 1 BOX contains a TUBE 1 30 g in 1 TUBE This package is contained within the BOX (69396-014-20) 2 NDC:69396-014-05 15 g in 1 TUBE None

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)

Revised: 01/2021 Trifecta Pharmaceuticals Usa Llc