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

FAMILY Wellness FRESH and CLEAN DANDRUFF PLUS CONDITIONER 2 IN 1 by

Drug Labeling and Warnings

FAMILY Wellness FRESH and CLEAN DANDRUFF PLUS CONDITIONER 2 IN 1 by is a Otc medication manufactured, distributed, or labeled by FAMILY DOLLAR SERVICES INC, Garcoa, Inc.. 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.

STORAGE AND HANDLING

Other information store at room temperature

Inactive ingredients

water, sodium laureth sulfate, cocamide MEA, sodium lauryl sulfate, glycol distearate, dimethicone, fragrance, cetyl alcohol, 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, yellow 5.

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 - 400 mL Bottle Label

FAMILY
Wellness™

COMPARE TO HEAD
& SHOULDERS®
ACTIVE
INGREDIENT*

FRESH &
CLEAN
2 IN 1

DANDRUFF SHAMPOO
PLUS CONDITIONER

PH BALANCED
WITH PYRITHIONE ZINC

• Fresh clean scent
• Helps improve the health
  of hair & scalp
• Paraben Free & Phthalate Free

GREEN APPLE
SCENTED

13.5 FL OZ (400 mL)

05-4744

INGREDIENTS AND APPEARANCE

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

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 55319-768
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)
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 YELLOW NO. 5 (UNII: I753WB2F1M)

Product Characteristics
Color	GREEN	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 55319-768-01	400 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	07/26/2024

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph drug	M032	07/26/2024

Labeler - FAMILY DOLLAR SERVICES INC (024472631)

Registrant - Garcoa, Inc. (036464697)

Establishment
Name	Address	ID/FEI	Business Operations
Garcoa, Inc.		036464697	MANUFACTURE(55319-768)