MEDICASP ANTI-DANDRUFF- coal tar shampoo

Medicasp by

Drug Labeling and Warnings

Medicasp by is a Otc medication manufactured, distributed, or labeled by Genomma Lab USA Inc., Garcoa, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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Drug Facts

Active ingredient

Solubilized Coal Tar Extract 2.5% (Coal Tar, 0.5%

Purpose

Anti-dandruff

Use

controls the symptoms of

♦ dandruff

♦ seborrheic dermatitis

♦ psoriasis

Warnings

For external use only

Ask a doctor before use if you have a condition which covers a large part of the body

When using this product

♦ do not get into the eyes. If contact occurs, rinse eyes thoroughly with water

♦ use caution exposing skin to sunlight after applying this product. It may increase your tendency to sunburn for up to 24 hours after application.

♦ do not use for prolonged periods without consulting a doctor

♦ do not use with other forms of psoriasis therapy such as ultra violet radiation or prescription drugs unless directed to do so by a doctor.

Stop use and ask a doctor if condition worsens or 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 right away.

Directions

♦ wet hair thoroughly

♦ apply the shampoo into the scalp and massage

♦ lather and leave on hair and scalp for several minutes

♦ rinse and repeat

♦ for best results use at least twice a week or as directed by a doctor

Other information

♦ store away from direct sunlight

♦ in rare instances, discoloration of gray, blonde, bleached or tinted hair may occur

Inactive ingredients

water, sodium laureth sulfate, cocamide MEA, cocamidopropyl betaine, laureth-4, fragrance, polysorbate 20, citric acid, sodium chloride, tetrasodium EDTA, DMDM hydantoin, caramel, red 40

Questions or comments?

1 877 99 GENOM (43666)

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Distributed by:
Genomma Lab USA, Inc.,
Houston, TX 77027

PRINCIPAL DISPLAY PANEL - 177 ml Bottle Carton

ORIGINAL STRENGTH SHAMPOO

SHAMPOO
Medicasp®

COAL TAR 0.5%

Controls the symptoms of:
PSORIASIS | DANDRUFF
SEBORRHEIC DERMATITIS

COAL TAR DANDRUFF SHAMPOO

6FL OZ (177 ml)

INGREDIENTS AND APPEARANCE

MEDICASP   ANTI-DANDRUFF
coal tar shampoo

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 50066-054
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Coal Tar (UNII: R533ESO2EC) (Coal Tar - UNII:R533ESO2EC)	Coal Tar	5 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
Water (UNII: 059QF0KO0R)
Sodium Laureth-3 Sulfate (UNII: BPV390UAP0)
COCO Monoethanolamide (UNII: C80684146D)
Cocamidopropyl Betaine (UNII: 5OCF3O11KX)
Laureth-4 (UNII: 6HQ855798J)
Polysorbate 20 (UNII: 7T1F30V5YH)
Citric Acid Monohydrate (UNII: 2968PHW8QP)
Sodium Chloride (UNII: 451W47IQ8X)
Edetate Sodium (UNII: MP1J8420LU)
DMDM Hydantoin (UNII: BYR0546TOW)
Caramel (UNII: T9D99G2B1R)
FD&C Red No. 40 (UNII: WZB9127XOA)

Product Characteristics
Color	BROWN	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 50066-054-01	1 in 1 CARTON	09/16/2013
1		177 mL in 1 BOTTLE, DISPENSING; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part358H	09/16/2013

Labeler - Genomma Lab USA Inc. (832323534)

Establishment
Name	Address	ID/FEI	Business Operations
Garcoa, Inc.		036464697	MANUFACTURE(50066-054)