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SKIN PROTECTOR WITH BREATHABLE BARRIER

Medically reviewed on May 4, 2018

Dosage form: cream
Ingredients: MICONAZOLE NITRATE 2g in 100g
Labeler: DIVERSIFIED MANUFACTURING CORP
NDC Code: 62172-202

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.

ACTIVE INGREDIENT

MICONAZOLE NITRATE 2%

PURPOSE

ANTIFUNGAL

USES

FOR THE TREATMENT AND PREVENTION OF:

  • ATHLETE'S FOOT
  • JOCK ITCH
  • RINGWORM

RELIEVES ITCHING, SCALING, CRACKING AND DISCOMFORT ASSOCIATED WITH THESE CONDITIONS.

WARNINGS

FOR EXTERNAL USE ONLY.

AVOID CONTACT WITH EYES. IN CASE OF CONTACT, RINSE THOROUGHLY WITH WATER.

STOP USE AND ASK A DOCTOR IF:

  • IRRITATION OCCURS
  • CONDITION WORSENS OR DOES NOT IMPROVE WITHIN 2 WEEKS FOR JOCK ITCH, OR WITHIN 4 WEEKS FOR ATHLETE'S FOOT AND RINGWORM.

KEEP OUT OF REACH OF CHILDREN. IN CASE OF ACCIDENTAL INGESTION CONTACT A PHYSICIAN OR POISON CONTROL CENTER IMMEDIATELY.

DIRECTIONS

CLEANSE AFFECTED AREA AND DRY THOROUGHLY. APPLY A THIN LAYER TO AFFECTED AREA TWICE DAILY OR AS DIRECTED BY A PHYSICIAN.

  • FOR JOCK ITCH USE DAILY FOR TWO WEEKS.
  • FOR ATHLETE'S FOOT AND RINGWORM USE DAILY FOR FOUR WEEKS.

OTHER INFORMATION
  • THIS PRODUCT IS NOT EFFECTIVE ON THE SCALP OR NAILS.
  • STORE AT ROOM TEMPERATURE 59° - 86°F (15° - 30°C).

INACTIVE INGREDIENTS

CAPRYLIC/CAPRIC TRIGLYCERIDE, CETEARETH-20, CETEARYL ALCOHOL, IMIDIAZOLIDINYL UREA, DIMETHICONE, DISODIUM EDTA, GLYCERYL STEARATE, METHYLPARABEN, PEG-40 CASTOR OIL, PEG-100 STEARATE, PETROLATUM, PROPYLENE GLYCOL, PROPYLPARABEN, STEARIC ACID, WATER, XANTHAN GUM.

QUESTIONS?

CALL 877.314.2554

SKIN PROTECTOR WITH BREATHABLE BARRIER 
miconazole nitrate cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:62172-202
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
MEDIUM-CHAIN TRIGLYCERIDES 
POLYOXYL 20 CETOSTEARYL ETHER 
CETOSTEARYL ALCOHOL 
IMIDUREA 
DIMETHICONE 
EDETATE DISODIUM 
GLYCERYL MONOSTEARATE 
METHYLPARABEN 
PEG-40 CASTOR OIL 
PEG-100 STEARATE 
PETROLATUM 
PROPYLENE GLYCOL 
PROPYLPARABEN 
STEARIC ACID 
WATER 
XANTHAN GUM 
Packaging
#Item CodePackage Description
1NDC:62172-202-16180 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart333C05/04/2016
Labeler - DIVERSIFIED MANUFACTURING CORP (185073996)
Establishment
NameAddressID/FEIOperations
DIVERSIFIED MANUFACTURING CORP185073996manufacture(62172-202), pack(62172-202)

 
DIVERSIFIED MANUFACTURING CORP

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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