TRIPLE ANTIFUNGAL- miconazole nitrate ointment 
Advantice Health, 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.

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Triple Paste Antifungal Ointment

Drug Facts

Active ingredient

Miconazole nitrate 2%

Purpose

Antifungal

Uses

Warnings

For external use only

When using this product avoid contact with the eyes.

Stop use and ask a doctor if

  • irritation occurs
  • there is no improvement within 2 weeks

Do not use on children under 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

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

Distributed by Advantice Health, LLC
Cedar Knolls, NJ 07927

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)

PRINCIPAL DISPLAY PANEL - 56.7 g Tube Carton
TRIPLE ANTIFUNGAL 
miconazole nitrate ointment
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:16864-040
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
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
ColorWHITEScore    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:16864-040-021 in 1 CARTON09/01/2021
156.7 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart333C09/01/2021
Labeler - Advantice Health, LLC (192527062)

Revised: 9/2021
Document Id: ca96dea6-0da9-4ff9-a08f-0267d56ae0b3
Set id: 9a47fb1b-a41f-4c8a-8e43-7332853c308e
Version: 1
Effective Time: 20210914
 
Advantice Health, LLC