TRIPLE AF- miconazole nitrate paste 
Summers Laboratories Inc

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SUMMERS LABS (as PLD) - TRIPLE PASTE AF (11086-040)

ACTIVE INGREDIENT

MICONAZOLE NITRATE 2%

PURPOSE

ANTIFUNGAL

Uses

WARNINGS

FOR EXTERNAL USE ONLY

When using this product avoid contact with eyes

Stop use and ask a doctor if

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 CONTCT A POISON CONTROL CENTER RIGHT AWAY.

Directions

Inactive ingredients

White petrolatum, zinc oxide, corn starch, anhydrous lanolin, stearyl alcohol, beeswax, cholesterol, polysorbate 80.

Triple Paste AF 2 oz_Unit Carton

TRIPLE  AF
miconazole nitrate paste
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:11086-040
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
PETROLATUM (UNII: 4T6H12BN9U)  
ZINC OXIDE (UNII: SOI2LOH54Z)  
STARCH, CORN (UNII: O8232NY3SJ)  
LANOLIN (UNII: 7EV65EAW6H)  
STEARYL ALCOHOL (UNII: 2KR89I4H1Y)  
YELLOW WAX (UNII: 2ZA36H0S2V)  
CHOLESTEROL (UNII: 97C5T2UQ7J)  
POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:11086-040-0128.7 g in 1 TUBE; Type 0: Not a Combination Product10/30/2013
2NDC:11086-040-0257 g in 1 TUBE; Type 0: Not a Combination Product10/30/2013
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM00510/30/2013
Labeler - Summers Laboratories Inc (002382612)

Revised: 10/2023
Document Id: 074d2952-be4d-9e5c-e063-6394a90a0692
Set id: 8d19b86d-b63c-485f-b143-2bc35f76c659
Version: 10
Effective Time: 20231009
 
Summers Laboratories Inc