TRIPLE ANTIFUNGAL- miconazole nitrate ointment

Triple Antifungal by

Drug Labeling and Warnings

Triple Antifungal by is a Otc medication manufactured, distributed, or labeled by Advantice Health, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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Drug Facts

Active ingredient

Miconazole nitrate 2%

Purpose

Antifungal

Uses

• For the treatment of superficial skin infections caused by yeast (Candida albicans)
• Relieves discomfort, irrit.ation, redness and chafing associated with jock itch
• Cures most jock itch (tinea cruris)

Warnings

For external use only

When using this productavoid contact with the eyes.

Stop use and ask a doctor if

• irritation occurs
• there is no improvement within 2 weeks

Do not use on childrenunder 2 years of age unless directed by a doctor.

Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center right away.

Directions

• Clean affected area and dry thoroughly
• Apply a thin layer of product over affected area twice daily (morning and night) or as directed by a doctor
• Supervise children in the use of this product
• Use daily for 2 weeks; If condition persists longer, consult a doctor
• This product is not effective on the scalp or nails

Other information

Store at room temperature 15°– 30°C (59°– 86°F)

Inactive ingredients

White petrolatum, zinc oxide, corn starch, anhydrous lanolin, stearyl alcohol, beeswax, cholesterol.

Questions?

1-800-345-0032

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Distributed by Advantice Health, LLC
Bridgewater, NJ 08807

PRINCIPAL DISPLAY PANEL - 56.7 g Tube Carton

Triple Paste AF ®

2% MICONAZOLE NITRATE ANTIFUNGAL OINTMENT

• Relieves burning, redness,
  irritation and discomfort
• Unique, soothing,
  water-resistant formula
• Lubricates skin to heal
  and prevent chafing

Help is on the way...

Net Wt. 2 oz (56.7 g)

INGREDIENTS AND APPEARANCE

TRIPLE ANTIFUNGAL 
miconazole nitrate ointment

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 16864-040
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
WHITE PETROLATUM (UNII: B6E5W8RQJ4)
STARCH, CORN (UNII: O8232NY3SJ)
LANOLIN (UNII: 7EV65EAW6H)
STEARYL ALCOHOL (UNII: 2KR89I4H1Y)
YELLOW WAX (UNII: 2ZA36H0S2V)
LEVOMENOL (UNII: 24WE03BX2T)
CHOLESTEROL (UNII: 97C5T2UQ7J)
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)
OAT (UNII: Z6J799EAJK)

Product Characteristics
Color	white	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 16864-040-02	1 in 1 CARTON	09/01/2021
1		56.7 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 Drug	M005	09/01/2021

Labeler - Advantice Health, LLC (192527062)