SKIN PROTECTOR WITH BREATHABLE BARRIER- miconazole nitrate cream

SKIN PROTECTOR WITH BREATHABLE BARRIER by

Drug Labeling and Warnings

SKIN PROTECTOR WITH BREATHABLE BARRIER by is a Otc medication manufactured, distributed, or labeled by DIVERSIFIED MANUFACTURING CORP. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

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

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

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

SKIN PROTECTOR WITH BREATHABLE BARRIER 
miconazole nitrate cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 62172-202
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MICONAZOLE NITRATE (UNII: VW4H1CYW1K) (MICONAZOLE - UNII:7NNO0D7S5M)	MICONAZOLE NITRATE	2 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
POLYOXYL 20 CETOSTEARYL ETHER (UNII: YRC528SWUY)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
IMIDUREA (UNII: M629807ATL)
DIMETHICONE (UNII: 92RU3N3Y1O)
EDETATE DISODIUM (UNII: 7FLD91C86K)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
METHYLPARABEN (UNII: A2I8C7HI9T)
PEG-40 CASTOR OIL (UNII: 4ERD2076EF)
PEG-100 STEARATE (UNII: YD01N1999R)
PETROLATUM (UNII: 4T6H12BN9U)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
STEARIC ACID (UNII: 4ELV7Z65AP)
WATER (UNII: 059QF0KO0R)
XANTHAN GUM (UNII: TTV12P4NEE)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 62172-202-16	180 g in 1 TUBE; Type 0: Not a Combination Product	05/04/2016

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part333C	05/04/2016

Labeler - DIVERSIFIED MANUFACTURING CORP (185073996)

Establishment
Name	Address	ID/FEI	Business Operations
DIVERSIFIED MANUFACTURING CORP		185073996	manufacture(62172-202)