FAMILY WELLNESS EVERYDAY CLEAN 2 IN 1 DANDRUFF PLUS CONDITIONER ANTI-DANDRUFF- pyrithione zinc shampoo

FAMILY Wellness EVERYDAY CLEAN 2 IN 1 DANDRUFF PLUS CONDITIONER by

Drug Labeling and Warnings

FAMILY Wellness EVERYDAY CLEAN 2 IN 1 DANDRUFF PLUS CONDITIONER 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

Pyrithione zinc 1 %

Purpose

Anti-dandruff

Use

helps prevent recurrence of flaking and itching associated with dandruff.

Warnings

For external use only.

When using this product avoid contact with the eyes. If contact occurs, rinse eyes thoroughly with water.

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

• shake well
• wet hair
• massage onto scalp
• rinse
• repeat if desired
• for best results use at least twice a week or as directed by a doctor
• for maximum dandruff control, use every time you shampoo.

Other information

store at room temperature

Inactive ingredients

water, sodium laureth sulfate, cocamide MEA, sodium lauryl sulfate, glycol distearate, dimethicone, fragrance, cetyl alcohol, polyquaternium-10, guar hydroxypropyltrimonium chloride, magnesium sulfate, sodium benzoate, magnesium carbonate hydroxide, ammonium laureth sulfate, benzyl alcohol, sodium chloride, methylchloroisothiazolinone, methylisothiazolinone, sodium xylenesulfonate, citric acid, blue 1, red 4.

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 - 700 mL Bottle Label

FAMILY Wellness™

COMPARE TO
HEAD & SHOULDERS®
ACTIVE INGREDIENT*

EVERYDAY
CLEAN
2 IN 1

DANDRUFF SHAMPOO
PLUS CONDITIONER

PH BALANCED
WITH PYRITHIONE ZINC

• Basic everyday cleaning
  and conditioning
• Leaves hair feeling soft
  and manageable
• Paraben Free & Phthalate Free

CLASSIC

23.7 FL OZ (700 mL)

05-4750

INGREDIENTS AND APPEARANCE

FAMILY WELLNESS EVERYDAY CLEAN 2 IN 1 DANDRUFF PLUS CONDITIONER   ANTI-DANDRUFF
shampoos (non-coloring), rinse-off [hair preparations (non-coloring)] shampoo

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 55319-386
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Pyrithione Zinc (UNII: R953O2RHZ5) (Pyrithione Zinc - UNII:R953O2RHZ5)	Pyrithione Zinc	10 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
Water (UNII: 059QF0KO0R)
SODIUM LAURETH-3 SULFATE (UNII: BPV390UAP0)
COCO MONOETHANOLAMIDE (UNII: C80684146D)
Sodium Lauryl Sulfate (UNII: 368GB5141J)
Glycol Distearate (UNII: 13W7MDN21W)
Dimethicone (UNII: 92RU3N3Y1O)
Cetyl Alcohol (UNII: 936JST6JCN)
POLYQUATERNIUM-10 (30000 MPA.S AT 2%) (UNII: C7RDC8Y4JS)
GUAR HYDROXYPROPYLTRIMONIUM CHLORIDE (UNII: B16G315W7A)
MAGNESIUM SULFATE, UNSPECIFIED FORM (UNII: DE08037SAB)
Sodium Benzoate (UNII: OJ245FE5EU)
Magnesium Carbonate Hydroxide (UNII: YQO029V1L4)
AMMONIUM LAURETH-5 SULFATE (UNII: 43ZIH89I48)
Benzyl Alcohol (UNII: LKG8494WBH)
Sodium Chloride (UNII: 451W47IQ8X)
Methylchloroisothiazolinone (UNII: DEL7T5QRPN)
Methylisothiazolinone (UNII: 229D0E1QFA)
Sodium Xylenesulfonate (UNII: G4LZF950UR)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
FD&C RED NO. 4 (UNII: X3W0AM1JLX)

Product Characteristics
Color	BLUE	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 55319-386-01	700 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	05/06/2024
2	NDC: 55319-386-02	400 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	05/06/2024
3	NDC: 55319-386-03	950 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	05/06/2024

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph drug	M032	05/06/2024

Labeler - FAMILY DOLLAR SERVICES INC (024472631)

Registrant - Garcoa, Inc. (036464697)

Establishment
Name	Address	ID/FEI	Business Operations
Sigan America, LLC		964976968	MANUFACTURE(55319-386)