ANTI-FUNGAL- miconazole nitrate cream 
Universal Distribution Center LLC

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Anti-Fungal Cream

Active Ingredient

Miconazole Nitrate 2.0%

Purpose

Antifungal

Uses

Warnings

Do not use on children under 2 years of age except under the advice and supervision of a doctor.

For external use only.

When using this productavoid contact with eyes.

Stop using this product and ask a doctor

Keep this and all drugs out of reach of children.

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

Directions

Other information

Inactive Ingredients

Benzoic Acid, Butylated Hydroxyanisole, Mineral Oil, PEGlicol-5-Oleate, Pegoxol-7 Stearate, Purified Water.

PRINCIPAL DISPLAY PANEL

Anti-Fungal Cream

NET WT 0.5 OZ (14 g)

image of package label

ANTI-FUNGAL 
miconazole nitrate cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:52000-021
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MICONAZOLE NITRATE (UNII: VW4H1CYW1K) (MICONAZOLE - UNII:7NNO0D7S5M) MICONAZOLE NITRATE0.02 g  in 1 g
Inactive Ingredients
Ingredient NameStrength
BENZOIC ACID (UNII: 8SKN0B0MIM)  
BUTYLATED HYDROXYANISOLE (UNII: REK4960K2U)  
MINERAL OIL (UNII: T5L8T28FGP)  
PEG-5 OLEATE (UNII: 0240V77G50)  
PEGOXOL 7 STEARATE (UNII: 3EW5AXE5X5)  
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:52000-021-411 in 1 BOX02/14/2022
1NDC:52000-021-4014 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM00504/15/2015
Labeler - Universal Distribution Center LLC (019180459)
Registrant - Savvy Care And Cosmetics Pvt. Ltd. (915039748)
Establishment
NameAddressID/FEIBusiness Operations
Savvy Care And Cosmetics Pvt. Ltd.915039748manufacture(52000-021)

Revised: 5/2024
Document Id: 18f39e0a-6734-31b9-e063-6294a90a7204
Set id: 8f316b0d-d308-4ae6-82c4-39bb0d1d474e
Version: 6
Effective Time: 20240521
 
Universal Distribution Center LLC