ASSURED T AND PLUS- coal tar shampoo
Bicooya Cosmetics Limited

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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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 eyes. If contact occurs, rinse eyes thoroughly with water.
•use caution in 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 ultraviolet 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
•massage shampoo into scalp
•lather. 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, Cocamidopropylamine oxide, laureth-4, ccocamidopropyl betaine, fragrance, sodium chloride, citric acid, DMDM Hydantoin, tetrasodium EDTA, PEG-150 distearate, caramel, FD+C red #33

COMPARE TO
ACTIVE INGREDIENT
in NEUTROGENA T/GEL SHAMPOO

shampoo
Therapeutic
FIGHTS ITCHY, FLAKY SCALP

Controls the symptoms
of psoriasis, seborrheic
dermatitis + dandruff
8.5 FL OZ
(251 mL)

ASSURED T AND PLUS
coal tar shampoo

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:58180-201
Route of Administration	TOPICAL

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

Ingredient Name	Strength
Inactive Ingredients
WATER (UNII: 059QF0KO0R)
SODIUM LAURETH SULFATE (UNII: BPV390UAP0)
COCAMIDOPROPYLAMINE OXIDE (UNII: M4SL82J7HK)
LAURETH-4 (UNII: 6HQ855798J)
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
DMDM HYDANTOIN (UNII: BYR0546TOW)
EDETATE SODIUM (UNII: MP1J8420LU)
PEG-150 DISTEARATE (UNII: 6F36Q0I0AC)
CARAMEL (UNII: T9D99G2B1R)
D&C RED NO. 33 (UNII: 9DBA0SBB0L)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:58180-201-01	251 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	01/21/2014	04/04/2020

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part358H	01/21/2014	04/04/2020

Labeler - Bicooya Cosmetics Limited (421310774)

Registrant - Bicooya Cosmetics Limited (421310774)

Name	Address	ID/FEI	Business Operations
Establishment
Bicooya Cosmetics Limited		421310774	manufacture(58180-201)

Revised: 4/2020

Document Id: d88becc1-5fda-4fd4-9de7-396d93b7d2c5

Set id: 9dd49ccd-11d2-4297-a4ba-94db61858d7c

Version: 10

Effective Time: 20200406

Bicooya Cosmetics Limited