MEDICASP  ANTI-DANDRUFF- coal tar shampoo 
Genomma Lab USA Inc.

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Medicasp Shampoo®
Anti-dandruff

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)

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)

PRINCIPAL DISPLAY PANEL - 177 ml Bottle Carton
MEDICASP   ANTI-DANDRUFF
coal tar shampoo
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50066-054
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Coal Tar (UNII: R533ESO2EC) (Coal Tar - UNII:R533ESO2EC) Coal Tar5 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
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
ColorBROWNScore    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:50066-054-011 in 1 CARTON09/16/2013
1177 mL in 1 BOTTLE, DISPENSING; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart358H09/16/2013
Labeler - Genomma Lab USA Inc. (832323534)
Establishment
NameAddressID/FEIBusiness Operations
Garcoa, Inc.036464697MANUFACTURE(50066-054)

Revised: 12/2018
Document Id: a6fd5981-d25d-4710-943e-9ec93fe1f8a2
Set id: 6f83214c-d4a9-44fa-8d8e-634907dfddd8
Version: 1
Effective Time: 20181211
 
Genomma Lab USA Inc.