WALGREENS CLINICAL STRENGTH MEDICATED DANDRUFF ANTI-DANDRUFF, ANTI-SEBORRHEIC DERMATITIS- selenium sulfide shampoo

Walgreens Clinical Strength Medicated Dandruff by

Drug Labeling and Warnings

Walgreens Clinical Strength Medicated Dandruff 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

Selenium Sulfide 1%

Purpose

Anti-dandruff, Anti-seborrheic dermatitis

Uses

Helps prevent recurrence of scalp itching and flaking associated with dandruff and seborrheic dermatitis.

Warnings

For external use only

If condition covers a large area of the body, consult your doctor before using this product.

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 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.

Inactive ingredients

water, ammonium laureth sulfate, cocamidopropyl betaine, ammonium lauryl sulfate, glycol distearate, cocamide MEA, ammonium xylenesulfonate, cetyl alcohol, stearyl alcohol, hydroxypropyl methylcellulose, dimethicone, sodium benzoate, fragrance, sodium citrate, disodium EDTA, methylchloroisothiazolinone, methylisothiazolinone, citric acid, sodium chloride, red 40.

Questions or comments?

1-800-925-4733

SPL UNCLASSIFIED SECTION

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

PRINCIPAL DISPLAY PANEL - 400 mL Bottle Label

Walgreens

Compare to the active ingredient in
Head & Shoulders® Clinical Strength††

WALGREENS
PHARMACIST RECOMMENDED

DANDRUFF SHAMPOO

Clinical
Strength

SELENIUM SULFIDE 1%

Medicated

• Strong medicated formula
  to help treat dandruff &
  seborrheic dermatitis

05-3271C

13.5 FL OZ (400 mL)

INGREDIENTS AND APPEARANCE

WALGREENS CLINICAL STRENGTH MEDICATED DANDRUFF  ANTI-DANDRUFF, ANTI-SEBORRHEIC DERMATITIS
selenium sulfide shampoo

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0363-9422
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)
Cocamidopropyl Betaine (UNII: 5OCF3O11KX)
Ammonium Lauryl Sulfate (UNII: Q7AO2R1M0B)
Glycol Distearate (UNII: 13W7MDN21W)
COCO MONOETHANOLAMIDE (UNII: C80684146D)
Ammonium Xylenesulfonate (UNII: 4FZY6L6XCM)
Cetyl Alcohol (UNII: 936JST6JCN)
Stearyl Alcohol (UNII: 2KR89I4H1Y)
Hypromellose, Unspecified (UNII: 3NXW29V3WO)
Dimethicone (UNII: 92RU3N3Y1O)
Sodium Benzoate (UNII: OJ245FE5EU)
SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR)
EDETATE DISODIUM (UNII: 7FLD91C86K)
Methylchloroisothiazolinone (UNII: DEL7T5QRPN)
Methylisothiazolinone (UNII: 229D0E1QFA)
Citric Acid Monohydrate (UNII: 2968PHW8QP)
Sodium Chloride (UNII: 451W47IQ8X)
FD&C RED NO. 40 (UNII: WZB9127XOA)

Product Characteristics
Color	ORANGE	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0363-9422-01	400 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	12/14/2016

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M032	12/14/2016

Labeler - Walgreen Company (008965063)

Registrant - Garcoa, Inc. (036464697)

Establishment
Name	Address	ID/FEI	Business Operations
Sigan Industries INC		255106239	MANUFACTURE(0363-9422) , LABEL(0363-9422) , PACK(0363-9422)