WALGREENS DANDRUFF ITCHY DRY SCALP DEFENSE ANTI-DANDRUFF- pyrithione zinc shampoo

Walgreens Dandruff Itchy Dry Scalp Defense by

Drug Labeling and Warnings

Walgreens Dandruff Itchy Dry Scalp Defense by is a Otc medication manufactured, distributed, or labeled by Walgreen Company, Garcoa, Inc., Sigan Industries, 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 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, ammonium lauryl sulfate, glycerin, ammonium laureth sulfate, cocamide MEA, glycol distearate, cetyl alcohol, fragrance, aloe barbadensis leaf juice, dimethicone, tocopheryl acetate, panthenol, linoleamidopropyl PG-dimonium chloride phosphate, dimethiconol, sodium lauryl glucose carboxylate, lauryl glucoside, amodimethicone, hydroxypropyl methylcellulose, laureth-9, C11-15 alketh-7, trideceth-12, propylene glycol, sodium chloride, sodium xylenesulfonate, hydroxyethylcellulose, citric acid, phenoxyethanol, methylchloroisothiazolinone, methylisothiazolinone, blue 1, yellow 5.

Questions or Comments?

1-800-925-4733

STOP USE

DISTRIBUTED BY: WALGREEN CO. 200 WILMOT RD.,
DEERFIELD, IL 60015

PRINCIPAL DISPLAY PANEL - 325 mL Bottle Label

Walgreens

WALGREENS
PHARMACIST RECOMMENDED†

Compare to the active ingredient
in Selsun Blue®††

ITCHY DRY SCALP
DEFENSE

Dandruff
Shampoo

PYRITHIONE ZINC 1%

• Daily scalp care
• Moisturizing formula to help
  nourish hair & scalp
• Formulated to help prevent
  & eliminate itchy scalp
  & visible flakes*

11 FL OZ (325 mL)

05-4486

INGREDIENTS AND APPEARANCE

WALGREENS DANDRUFF ITCHY DRY SCALP DEFENSE   ANTI-DANDRUFF
pyrithione zinc shampoo

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0363-4138
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)
Ammonium Lauryl Sulfate (UNII: Q7AO2R1M0B)
Glycerin (UNII: PDC6A3C0OX)
COCO MONOETHANOLAMIDE (UNII: C80684146D)
Glycol Distearate (UNII: 13W7MDN21W)
Cetyl Alcohol (UNII: 936JST6JCN)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
Dimethicone (UNII: 92RU3N3Y1O)
.ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8)
Panthenol (UNII: WV9CM0O67Z)
LINOLEAMIDOPROPYL PROPYLENE GLYCOL-DIMONIUM CHLORIDE PHOSPHATE (UNII: 5Q87K461JO)
DIMETHICONOL (2000 CST) (UNII: T74O12AN6Y)
Lauryl Glucoside (UNII: 76LN7P7UCU)
AMODIMETHICONE (800 CST) (UNII: 363Z2T48P7)
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)
POLIDOCANOL (UNII: 0AWH8BFG9A)
C11-15 ALKETH-7 (UNII: 261HPE0IS3)
Trideceth-12 (UNII: YFY3KG5Y7O)
Propylene Glycol (UNII: 6DC9Q167V3)
Sodium Chloride (UNII: 451W47IQ8X)
Sodium Xylenesulfonate (UNII: G4LZF950UR)
HYDROXYETHYL CELLULOSE, UNSPECIFIED (UNII: T4V6TWG28D)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
Phenoxyethanol (UNII: HIE492ZZ3T)
Methylchloroisothiazolinone (UNII: DEL7T5QRPN)
Methylisothiazolinone (UNII: 229D0E1QFA)
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: 0363-4138-01	325 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	12/19/2022

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph drug	M032	12/19/2022

Labeler - Walgreen Company (008965063)

Registrant - Garcoa, Inc. (036464697)

Establishment
Name	Address	ID/FEI	Business Operations
Sigan Industries, INC		255106239	MANUFACTURE(0363-4138)