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 Rugby, Trifecta Pharmaceuticals USA. 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 (1-800-222-1222) immediately.

Uses

• proven clinically effective in the treatment of most athlete's foot (tinea pedis), jock itch (tinea cruris), and ringworm (tinea corporis)
• 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 doctor. When using this product avoid contact with the eyes.

Stop use and ask a doctor 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).

Other information

Distributed by:
Rugby Laboratories

Indianapolis, IN. 46268

800-616-2471

www.majorpharmaceuticals.com

This product is not manufactured or distributed by Wellspring Pharmaceutical Corporation owner of the registered trademark Micatin.

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 doctor Pay special attention to the spaces between the toes Wear well fitting, ventilated shoes Change socks at least once daily.

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

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

This product is not effective on the scalp or nails.

INACTIVE INGREDIENT

Inactive ingredientsCarbomer, alcohol, cetostearyl alcohol, dimethyl sulfoxide, edetate disodium, ethylparaben, glycerol, mineral oil, mono and di glycerides, polyoxyethylene lauryl ether, 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.

Packaging

INGREDIENTS AND APPEARANCE

MICONAZOLE NITRATE 2% CREAM ANTIFUNGAL 
miconazole nitrate cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0536-1375
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
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
DIMETHYL SULFOXIDE (UNII: YOW8V9698H)
EDETATE DISODIUM (UNII: 7FLD91C86K)
ETHYLPARABEN (UNII: 14255EXE39)
GLYCERIN (UNII: PDC6A3C0OX)
MINERAL OIL (UNII: T5L8T28FGP)
LAURETH-30 (UNII: W9D845551A)
WATER (UNII: 059QF0KO0R)
STEARIC ACID (UNII: 4ELV7Z65AP)
TROLAMINE (UNII: 9O3K93S3TK)
PETROLATUM (UNII: 4T6H12BN9U)
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)
GLYCERYL MONO AND DIPALMITOSTEARATE (UNII: KC98RO82HJ)
ALCOHOL (UNII: 3K9958V90M)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0536-1375-75	1 in 1 BOX	02/07/2023
1		28.3 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part333C	02/07/2023

Labeler - Rugby (079246066)

Registrant - Trifecta Pharmaceuticals USA (079424163)