FAMILY WELLNESS THERAPEUTIC TPLUS PLUS DANDRUFF ANTI-DANDRUFF, ANTI-SEBORRHEIC DERMATITIS, ANTI-PSORIASIS- coal tar shampoo

Family Wellness Therapeutic Tplus PLUS Dandruff by

Drug Labeling and Warnings

Family Wellness Therapeutic Tplus PLUS Dandruff by is a Otc medication manufactured, distributed, or labeled by FAMILY DOLLAR SERVICES INC, Garcoa, INC, Sigan America, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient

Solubilized Coal Tar Extract 2.50% (Coal Tar, 0.50%)

Purpose

Anti-dandruff, anti-seborrheic dermatitis, anti-psoriasis

Use

controls the symptom of:

• dandruff
• seborrheic dermatitis
• psoriasis

Warnings

For external use only.

Ask a doctor before use if you have a condition that 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 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 this product 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 (1-800-222-1222) right away.

Directions

• for best results use at least twice a week or as directed by a doctor
• wet hair thoroughly
• massage shampoo into the scalp
• lather, leave on hair and scalp for several minutes.
• rinse and repeat

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, disodium EDTA, phenoxyethanol, methylchloroisothiazolinone, methylisothiazolinone, red 40, blue 1, yellow 5, yellow 6.

Questions or comments?

1-866-567-8600

SPL UNCLASSIFIED SECTION

DISTRIBUTED BY: MIDWOOD BRANDS, LLC
500 VOLVO PKWY, CHESAPEAKE, VA 23320 USA

PRINCIPAL DISPLAY PANEL - 251 mL Bottle Label

FAMILY
Wellness™

THERAPEUTIC
T + PLUS

DANDRUFF SHAMPOO

2.50% COAL TAR
TOPICAL SOLUTION
(0.50% COAL TAR)

CLEANSING FORMULA

FIGHTS ITCHING & FLAKING

Controls symptoms of

• psoriasis
• seborrheic dermatitis
• dandruff

ORIGINAL
STRENGTH

8.5 FL OZ (251 mL)

05-4754

INGREDIENTS AND APPEARANCE

FAMILY WELLNESS THERAPEUTIC TPLUS PLUS DANDRUFF   ANTI-DANDRUFF, ANTI-SEBORRHEIC DERMATITIS, ANTI-PSORIASIS
shampoos (non-coloring), rinse-off [hair preparations (non-coloring)] shampoo

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 55319-485
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 LAURYL SULFATE (UNII: 368GB5141J)
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 DISODIUM (UNII: 7FLD91C86K)
Phenoxyethanol (UNII: HIE492ZZ3T)
Methylchloroisothiazolinone (UNII: DEL7T5QRPN)
Methylisothiazolinone (UNII: 229D0E1QFA)
FD&C RED NO. 40 (UNII: WZB9127XOA)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)

Product Characteristics
Color	BROWN	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 55319-485-01	251 mL in 1 BOTTLE; Type 0: Not a Combination Product	05/20/2024

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph drug	M032	05/20/2024

Labeler - FAMILY DOLLAR SERVICES INC (024472631)

Registrant - Garcoa, INC (036464697)

Establishment
Name	Address	ID/FEI	Business Operations
Sigan America, LLC		964976968	MANUFACTURE(55319-485)