Skin Protector With Breathable Barrier (Miconazole Nitrate) Cream [Diversified Manufacturing Corp] -

SKIN PROTECTOR WITH BREATHABLE BARRIER (MICONAZOLE NITRATE) CREAM [DIVERSIFIED MANUFACTURING CORP]
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NDC	62172-202-16
Set ID	e267ecbc-c07c-493e-8a96-ca58a8ac8e67
Category	HUMAN OTC DRUG LABEL
Packager	DIVERSIFIED MANUFACTURING CORP
Generic Name
Product Class	Azole Antifungal
Product Number
Application Number	PART333C

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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

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

Ingredient Name	Strength
Inactive Ingredients
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)

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

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

Labeler - DIVERSIFIED MANUFACTURING CORP (185073996)

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

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Medic