MICATIN- miconazole nitrate cream 
WellSpring Pharmaceutical Corporation

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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Micatin

ACTIVE INGREDIENT/INGREDIENTE ACTIVO

Miconazole nitrate 2% / Nitrato de Miconazol 2%

PURPOSE/PROPÓSITO

Antifungal/Antifúngico

USES/USOS

WARNINGS/ADVERTENCIAS

For external use only / Para uso externo únicamente

Do not use on children less than 2 years of age unless directed by a doctor / No administre en niños menores de 2 años, a menos que indicado por un médico

When using this product / Al usar este producto

avoid contact with the eyes / evite el contacto con los ojos

Stop use and ask a doctor if / Pare el uso y consulte a un médico

  • irritation occurs / si se produce irritación
  • condition persists  / condiciones persisten
  • there is no improvement of athlete's foot or ringworm within 4 weeks or jock itch within 2 weeks / si no se mejora el pie de atleta o tiña en 4 semanas o la sarna deportiva en 2 semanas

Keep out of reach of children. Mantenga fuera del alcance de los niños,

If swallowed, get medical help or contact a Poison Control Center right away. (1-800-222-1222) /
en caso de ingestión, obtenga ayuda médica o póngase en contacto con el Centro de Control de Envenenamiento inmediatamente.

DIRECTIONS/INSTRUCCIONES

OTHER INFORMATION/OTRA INFORMACION

INACTIVE INGREDIENTS/INGREDIENTES INACTIVOS

benzoic acid, butylated hydroxyanisole, mineral oil, peglicol 5 oleate, pegoxol 7 stearate, purified water /
aceite mineral, ácido benzoico, agua purificada, butilhidroxianisol, estearato de pegoxol 7, oleato de peglicol 5

QUESTIONS?/¿PREGUNTAS?

1-844-241-5454 www.micatin.com

DISTRIBUTED BY / DIST.

WellSpring Pharmaceutical Corporation
Sarasota, FL 34243 USA

© WellSpring 2016

Made in Canada / Hecho en Canada

PACKAGE LABEL

Tube Label

PACKAGE LABEL

Inside Label
MICATIN 
miconazole nitrate cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:65197-103
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MICONAZOLE NITRATE (UNII: VW4H1CYW1K) (MICONAZOLE - UNII:7NNO0D7S5M) MICONAZOLE NITRATE20 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
BENZOIC ACID (UNII: 8SKN0B0MIM)  
BUTYLATED HYDROXYANISOLE (UNII: REK4960K2U)  
MINERAL OIL (UNII: T5L8T28FGP)  
Product Characteristics
ColorWHITEScore    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:65197-103-0514 g in 1 TUBE; Type 0: Not a Combination Product06/24/2009
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart333C06/24/2009
Labeler - WellSpring Pharmaceutical Corporation (110999054)

Revised: 4/2016
Document Id: 89b3a546-fbdc-4c1d-96af-c4f83be1f6d2
Set id: 96c56ba1-c3a8-48ce-ab58-550959485e3c
Version: 9
Effective Time: 20160407
 
WellSpring Pharmaceutical Corporation