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NDC 68093-7232-02 MG217 Psoriasis 0.03 g/g Details

MG217 Psoriasis 0.03 g/g

MG217 Psoriasis is a TOPICAL SHAMPOO in the HUMAN OTC DRUG category. It is labeled and distributed by Wisconsin Pharmacal Company. The primary component is COAL TAR.

Product Information

NDC	68093-7232
Product ID	68093-7232_7cafb511-0ab8-f3b4-e053-2991aa0a2e0b
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	MG217 Psoriasis
Proprietary Name Suffix	Medicated Conditioning
Non-Proprietary Name	Coal Tar
Product Type	HUMAN OTC DRUG
Dosage Form	SHAMPOO
Route	TOPICAL
Active Ingredient Strength	0.03
Active Ingredient Units	g/g
Substance Name	COAL TAR
Labeler Name	Wisconsin Pharmacal Company
Pharmaceutical Class	n/a
DEA Schedule	n/a
Marketing Category	OTC MONOGRAPH FINAL
Application Number	part358H
Listing Certified Through	2024-12-31

Package

Package Images

NDC 68093-7232-02 (68093723202)

Pricing Information	N/A
NDC Package Code	68093-7232-2
Billing NDC	68093723202
Package	1 BOTTLE in 1 CARTON (68093-7232-2) / 240 g in 1 BOTTLE
Marketing Start Date	2015-03-01
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL 7cafb511-0ab7-f3b4-e053-2991aa0a2e0b Details

SPL UNCLASSIFIED SECTION

Active Ingredient

Coal Tar 3% (from Coal Tar Topical Solution, USP 20%)

SPL UNCLASSIFIED SECTION

Purpose

Psoriasis, Seborrheic Dermatitis, Dandruff Treatment

SPL UNCLASSIFIED SECTION

Uses

For the temporary relief of these symptoms associated with psoriasis, seborrheic dermatitis or dandruff

itching
scaling
flaking
redness
irritation of the scalp.

Helps prevent recurrence.

SPL UNCLASSIFIED SECTION

Warnings

For external use only

Ask a doctor before use

if condition covers a large area of the body.

When using this product

avoid contact with the eyes. If contact occurs, rinse eyes thoroughly with water.
use caution in exposing skin to sunlight. It may increase your tendency to sunburn for up to 24 hours after application.
do not use with other forms of psoriasis therapy such as ultraviolet radiation or prescription drugs unless directed by a physician.
do not use for prolonged periods without consulting a physician.

Stop use and ask a doctor if

condition worsens.
condition does not improve after regular use of this product as directed.

Keep out of reach of children.

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

WARNING: This product can expose you to chemicals including Coal Tar, which is known to the State of California to cause cancer. For more information go to www.P65Warnings.ca.gov

SPL UNCLASSIFIED SECTION

Directions

shake well before using.
wet hair then massage liberal amount of MG217 into the scalp and leave on for several minutes. Rinse thoroughly.
for best results, use at least twice a week or as directed by a physician.

SPL UNCLASSIFIED SECTION

Inactive ingredients

Deionized Water, Sodium Lauryl Ether Sulfate, Cocamidopropyl Betaine, Lauramidopropyl Hydroxysultaine, Palmitic Betaine, Guar Hydroxypropyl-trimonium Chloride, Hydrolyzed Collagen, Phenoxyethanol, Methyl Paraben, n-Butyl Paraben, Ethyl Paraben, lsobutyl Paraben, Propyl Paraben, Fragrance, FD&C Blue #1

SPL UNCLASSIFIED SECTION

Questions? 1-800-635-3696

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

MG217 PSORIASIS MEDICATED CONDITIONING

coal tar shampoo

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:68093-7232
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
COAL TAR (UNII: R533ESO2EC) (COAL TAR - UNII:R533ESO2EC)	COAL TAR	0.03 g in 1 g

Ingredient Name	Strength
Inactive Ingredients
PORK COLLAGEN (UNII: I8442U2G7J)
ISOBUTYLPARABEN (UNII: 0QQJ25X58G)
WATER (UNII: 059QF0KO0R)
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)
GUAR GUM (UNII: E89I1637KE)
METHYLPARABEN (UNII: A2I8C7HI9T)
SODIUM LAURETH SULFATE (UNII: BPV390UAP0)
BUTYLPARABEN (UNII: 3QPI1U3FV8)
ETHYLPARABEN (UNII: 14255EXE39)
LAURAMIDOPROPYL HYDROXYSULTAINE (UNII: VPE363894V)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
BETAINE (UNII: 3SCV180C9W)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:68093-7232-1	1 in 1 CARTON	03/01/2015
1		120 g in 1 BOTTLE; Type 0: Not a Combination Product
2	NDC:68093-7232-2	1 in 1 CARTON	03/01/2015
2		240 g in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part358H	03/01/2015

Labeler - Wisconsin Pharmacal Company (800873986)

Registrant - Wisconsin Pharmacal Company (800873986)

Name	Address	ID/FEI	Business Operations
Establishment
Wisconsin Pharmacal Company		800873986	manufacture(68093-7232)

Revised: 12/2018

Document Id: 7cafb511-0ab8-f3b4-e053-2991aa0a2e0b

Set id: 7cafb511-0ab7-f3b4-e053-2991aa0a2e0b

Version: 1

Effective Time: 20181210

Search by Drug Name or NDC

NDC 68093-7232-02 MG217 Psoriasis 0.03 g/g Details

MG217 Psoriasis 0.03 g/g

Product Information

Package

Package Images

NDC 68093-7232-02 (68093723202)

Contents

Standard Product Labeling (SPL)/Prescribing Information SPL 7cafb511-0ab7-f3b4-e053-2991aa0a2e0b Details

SPL UNCLASSIFIED SECTION

SPL UNCLASSIFIED SECTION

SPL UNCLASSIFIED SECTION

SPL UNCLASSIFIED SECTION

SPL UNCLASSIFIED SECTION

SPL UNCLASSIFIED SECTION

SPL UNCLASSIFIED SECTION

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

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