MEIJER MEDICATED SELENIUM SULFIDE ANTI-DANDRUFF- selenium sulfide shampoo

Meijer Medicated Selenium Sulfide by

Drug Labeling and Warnings

Meijer Medicated Selenium Sulfide by is a Otc medication manufactured, distributed, or labeled by Meijer Distribution, Inc, Garcoa, Inc., SV Labs Toronto Corporation. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient

Selenium Sulfide 1%

Purpose

Anti-dandruff

Use

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

Warnings

For external use only

As a doctor before use if you have

• ◆ seborrheic dermatitis in areas other than the scalp.

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, cocamidopropyl betaine, cocamide MEA, magnesium aluminum silicate, hydroxypropyl methylcellulose, fragrance, menthol, DMDM Hydantoin, citric acid, sodium chloride, blue 1, red 33

SPL UNCLASSIFIED SECTION

DIST BY MEIJER
DISTRIBUTION, INC.
2929 WALKER AVE NW
GRAND RAPIDS, MI 49544

PRINCIPAL DISPLAY PANEL - 325 mL Bottle Label

meijer™

MEDICATED

selenium
sulfide
DANDRUFF
SHAMPOO

formulated to fight
seborrheic dermatitis
and dandruff symptoms
with menthol
1% selenium sulfide

Original
Formula

Compare to
Selsun Blue®
active ingredient*

11 FL OZ (325 mL)

05-1522B

INGREDIENTS AND APPEARANCE

MEIJER MEDICATED SELENIUM SULFIDE   ANTI-DANDRUFF
selenium sulfide shampoo

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 41250-545
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)
Cocamidopropyl Betaine (UNII: 5OCF3O11KX)
Coco Monoethanolamide (UNII: C80684146D)
Magnesium Aluminum Silicate (UNII: 6M3P64V0NC)
Hypromellose, Unspecified (UNII: 3NXW29V3WO)
Menthol, Unspecified Form (UNII: L7T10EIP3A)
DMDM Hydantoin (UNII: BYR0546TOW)
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: 41250-545-01	325 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	05/11/2010

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part358H	05/11/2010

Labeler - Meijer Distribution, INC (006959555)

Registrant - SIGAN INDUSTRIES INC. (255106239)

Establishment
Name	Address	ID/FEI	Business Operations
SIGAN INDUSTRIES INC.		255106239	MANUFACTURE(41250-545)