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NDC 62172-0202-16 SKIN PROTECTOR WITH BREATHABLE BARRIER 2 g/100g Details

SKIN PROTECTOR WITH BREATHABLE BARRIER 2 g/100g

SKIN PROTECTOR WITH BREATHABLE BARRIER is a TOPICAL CREAM in the HUMAN OTC DRUG category. It is labeled and distributed by DIVERSIFIED MANUFACTURING CORP. The primary component is MICONAZOLE NITRATE.

MedlinePlus Drug Summary

Topical miconazole is used to treat tinea corporis(ringworm; fungal skin infection that causes a red scaly rash on different parts of the body), tinea cruris (jock itch; fungal infection of the skin in the groin or buttocks), and tinea pedis (athlete's foot; fungal infection of the skin on the feet and between the toes). Miconazole is in a class of antifungal medications called imidazoles. It works by stopping the growth of fungi that cause infection. Not all products should be used to treat all of these conditions. Please read the label for each product to select the one to treat your condition.

Related Packages: 62172-0202-16
Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Miconazole Topical

Product Information

NDC	62172-0202
Product ID	62172-202_d60ec865-026c-1702-e053-2995a90aca75
Associated GPIs
GCN Sequence Number	n/a
GCN Sequence Number Description	n/a
HIC3	n/a
HIC3 Description	n/a
GCN	n/a
HICL Sequence Number	n/a
HICL Sequence Number Description	n/a
Brand/Generic	n/a
Proprietary Name	SKIN PROTECTOR WITH BREATHABLE BARRIER
Proprietary Name Suffix	n/a
Non-Proprietary Name	MICONAZOLE NITRATE
Product Type	HUMAN OTC DRUG
Dosage Form	CREAM
Route	TOPICAL
Active Ingredient Strength	2
Active Ingredient Units	g/100g
Substance Name	MICONAZOLE NITRATE
Labeler Name	DIVERSIFIED MANUFACTURING CORP
Pharmaceutical Class	Azole Antifungal [EPC], Azoles [CS]
DEA Schedule	n/a
Marketing Category	OTC MONOGRAPH FINAL
Application Number	part333C
Listing Certified Through	2023-12-31

Package

Package Images

NDC 62172-0202-16 (62172020216)

Pricing Information	N/A
NDC Package Code	62172-202-16
Billing NDC	62172020216
Package	180 g in 1 TUBE (62172-202-16)
Marketing Start Date	2016-05-04
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL e267ecbc-c07c-493e-8a96-ca58a8ac8e67 Details

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.

SPL UNCLASSIFIED SECTION

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.

SPL UNCLASSIFIED SECTION

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

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)

Revised: 1/2022

Document Id: d60ec865-026c-1702-e053-2995a90aca75

Set id: e267ecbc-c07c-493e-8a96-ca58a8ac8e67

Version: 5

Effective Time: 20220120

Search by Drug Name or NDC

NDC 62172-0202-16 SKIN PROTECTOR WITH BREATHABLE BARRIER 2 g/100g Details

SKIN PROTECTOR WITH BREATHABLE BARRIER 2 g/100g

MedlinePlus Drug Summary

Product Information

Package

Package Images

NDC 62172-0202-16 (62172020216)

Contents

Standard Product Labeling (SPL)/Prescribing Information SPL e267ecbc-c07c-493e-8a96-ca58a8ac8e67 Details

ACTIVE INGREDIENT

PURPOSE

USES

WARNINGS

SPL UNCLASSIFIED SECTION

SPL UNCLASSIFIED SECTION

DIRECTIONS

OTHER INFORMATION

INACTIVE INGREDIENTS

QUESTIONS?

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

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