FAMILY WELLNESS MAXIMUM STRENGTH DANDRUFF ANTI-DANDRUFF, ANTI-SEBORRHEIC DERMATITIS, ANTI-PSORIASIS- selenium sulfide shampoo

FAMILY Wellness MAXIMUM STRENGTH DANDRUFF by

Drug Labeling and Warnings

FAMILY Wellness MAXIMUM STRENGTH DANDRUFF by is a Otc medication manufactured, distributed, or labeled by FAMILY DOLLAR SERVICES INC, Garcoa, Inc., Sigan Industries INC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient

Selenium sulfide 1%

Purpose

Anti-Seborrheic Dermatitis, anti-dandruff

Uses

for the relief of flaking, and itching associated with dandruff, and seborrheic dermatitis and to help prevent recurrence.

Warnings

For external use only.

Ask a doctor before use if

• condition covers a large area of the body.

When using this product

• avoid contact with the eyes. If contact occurs, rinse eyes thoroughly with water.
• for color-treated or permed hair, rinse thoroughly.

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

• shake well
• shampoo, then rinse thoroughly
• for best results, use at least twice a week or as directed by a doctor.

Other information

• store at room temperature

Inactive ingredients

water, ammonium laureth sulfate, ammonium lauryl sulfate, cocamide MEA, cocamidopropyl betaine, magnesium aluminum silicate, hydroxypropyl methylcellulose, fragrance, menthol, chlorphenesin, phenoxyethanol, citric acid, sodium chloride, blue 1, red 33.

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 - 325 mL Bottle Label

FAMILY
Wellness™

COMPARE TO
THE ACTIVE
INGREDIENT IN
SELSUN BLUE®
MEDICATED
DANDRUFF
SHAMPOO*

MAXIMUM STRENGTH

DANDRUFF
SHAMPOO

SELENIUM SULFIDE 1%

• For the relief of seborrheic
  dermatitis & dandruff symptoms
• Helps control flaking & itching
• For healthier-looking hair & scalp
• Paraben free & Phthalate free

MEDICATED
+ MENTHOL

11 FL OZ (325 mL)

05-4742

INGREDIENTS AND APPEARANCE

FAMILY WELLNESS MAXIMUM STRENGTH 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: 55319-949
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SELENIUM SULFIDE (UNII: Z69D9E381Q) (SELENIUM SULFIDE - UNII:Z69D9E381Q)	SELENIUM SULFIDE	10 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
Water (UNII: 059QF0KO0R)
AMMONIUM LAURETH-5 SULFATE (UNII: 43ZIH89I48)
Ammonium Lauryl Sulfate (UNII: Q7AO2R1M0B)
COCO MONOETHANOLAMIDE (UNII: C80684146D)
Cocamidopropyl Betaine (UNII: 5OCF3O11KX)
Magnesium Aluminum Silicate (UNII: 6M3P64V0NC)
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)
MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A)
Chlorphenesin (UNII: I670DAL4SZ)
Phenoxyethanol (UNII: HIE492ZZ3T)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
Sodium Chloride (UNII: 451W47IQ8X)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
D&C RED NO. 33 (UNII: 9DBA0SBB0L)

Product Characteristics
Color	GREEN	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 55319-949-01	325 mL in 1 BOTTLE; Type 0: Not a Combination Product	07/29/2024

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph drug	M032	07/29/2024

Labeler - FAMILY DOLLAR SERVICES INC (024472631)

Registrant - Garcoa, Inc. (036464697)

Establishment
Name	Address	ID/FEI	Business Operations
Sigan Industries INC		255106239	MANUFACTURE(55319-949) , LABEL(55319-949) , PACK(55319-949)