Medication Guide App

Terapie Anti-Fungal

Dosage form: cream
Ingredients: MICONAZOLE NITRATE 2g in 100g
Labeler: Armand Dupree Inc.
NDC Code: 10849-002

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.

Terapie Anti-Fungal Cream

Active Ingredient

Miconazole Nitrate 2%

Uses:

Treatment of athlete’s foot. Relieves itching, scaling, cracking and burning.

Warnings

Avoid eye contact.

Do not use

on children under 2 years of age, unless directed by doctor.

Do not use on irritated or broken skin.

Stop Use

- Discontinue use if irritation, redness or rash develops.

Pregnant Or Breast-Feeding

- If pregnant or breast- feeding, ask a health professional before use.

- For external use only.

Keep out of reach of children

- Keep out of reach of children.

Other Safety Information

- If swallowed, get medical help or contact a Poison Control Center immediately.

Directions:

Wash the affected area and dry thoroughly. Apply a thin layer of the product over the affected area twice a day (morning and night) or as directed by a doctor. Supervise children in the use of this product. Pay special attention to spaces between the toes. Wear well-fitting, ventilated shoes. Change shoes and socks at least once daily. Use daily for 4 weeks. If condition persists longer, consult a doctor. This product is not effective on the scalp and nails.

Inactive Ingredients:

Cetyl Alcohol, Methylparaben, Paraffin, Polysorbate 60, Propylene Glycol, Propylparaben, Sorbitan Stearate, Stearyl Alcohol, Water.

Purpose

Anti-fungal

Description

Made in Mexico for: HOUSE OF FULLER, S. de R.L. de C.V.  Francisco Villa 5, Col. Tepepan,  Xochimilco, Mexico, D.F. C.P. 16020  HFU700126V99  Dist. in the U.S.A. by:  ARMAND DUPREE, Inc., 14901  S. Orange Blossom Trail,  Orlando, FL 32837  Country of Origin: MEXICO  BTAU

terapie

Effective Treatment Of Athelete's Foot

Anti-Fungal Cream

Micanazole Nitrate 2%

CONT.NET. 60g

NET WT 2.12 OZ.

terapie  EFFECTIVE TREATMENT OF ATHLETE´S FOOT  ANTI-FUNGAL CREAM  Miconazole Nitrate 2%  CONT. NET. 60 g  NET WT. 2.12 OZ.

Product Package Inner Label

Product Package Outer Label

TERAPIE ANTI-FUNGAL 
miconazole nitrate cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:10849-002
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MICONAZOLE NITRATE (MICONAZOLE) MICONAZOLE NITRATE2 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
CETYL ALCOHOL 
METHYLPARABEN 
PARAFFIN 
POLYSORBATE 60 
PROPYLENE GLYCOL 
PROPYLPARABEN 
SORBITAN MONOSTEARATE 
STEARYL ALCOHOL 
WATER 
Packaging
#Item CodePackage Description
1NDC:10849-002-011 TUBE (TUBE) in 1 CARTON
160 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart333C11/04/2011
Labeler - Armand Dupree Inc. (013966604)
Establishment
NameAddressID/FEIOperations
Laboratorios Kener S.A. de C.V.810347658manufacture

Revised: 11/2011
 
Armand Dupree Inc.

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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