Assured T And Plus by Bicooya Cosmetics Limited Drug Facts

Assured T And Plus by

Drug Labeling and Warnings

Assured T And Plus by is a Otc medication manufactured, distributed, or labeled by Bicooya Cosmetics Limited. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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)

image of principal display panel
ASSURED T AND PLUS 
coal tar shampoo
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 58180-201
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 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)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 58180-201-01251 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product01/21/201404/04/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart358H01/21/201404/04/2020
Labeler - Bicooya Cosmetics Limited (421310774)
Registrant - Bicooya Cosmetics Limited (421310774)
Establishment
NameAddressID/FEIBusiness Operations
Bicooya Cosmetics Limited421310774manufacture(58180-201)

Revised: 4/2020
 
Bicooya Cosmetics Limited