MEIJER MEDICATED SELENIUM SULFIDE ANTI-DANDRUFF- selenium sulfide shampoo

United States - English - NLM (National Library of Medicine)

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Active ingredient:
Selenium Sulfide (UNII: Z69D9E381Q) (Selenium Sulfide - UNII:Z69D9E381Q)
Available from:
Meijer Distribution, INC
Administration route:
TOPICAL
Prescription type:
OTC DRUG
Therapeutic indications:
Anti-dandruff for the relief of flaking, and itching due to dandruff and seborrheic dermatitis, and to help prevent their recurrence.
Authorization status:
OTC monograph final
Authorization number:
41250-545-01

MEIJER MEDICATED SELENIUM SULFIDE ANTI-DANDRUFF- selenium sulfide shampoo

Meijer Distribution, INC

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they

comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Meijer

Medicated Selenium Sulfide Dandruff Shampoo

Anti-Dandruff

Drug Facts

Active ingredient

Selenium Sulfide 1%

Purpos e

Anti-dandruff

Us e

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

When using this product

Stop use and ask a doctor if

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right

away.

Directions

Other information

seborrheic dermatitis in areas other than the scalp.

avoid contact with the eyes. If contact occurs, rinse eyes thoroughly with water.

for color-treated or permed hair, rinse thoroughly.

condition worsens or does not improve after regular use of this product as directed.

shake well

shampoo, then rinse thoroughly

for best results, use at least twice a week or as directed by a doctor.

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

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

MEIJER MEDICATED SELENIUM SULFIDE ANTI-DANDRUFF

selenium sulfide shampoo

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:41250 -545

Route of Administration

TOPICAL

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

Selenium Sulfide (UNII: Z6 9 D9 E38 1Q) (Selenium Sulfide - UNII:Z6 9 D9 E38 1Q)

Selenium Sulfide

10 mg in 1 mL

Meijer Distribution, INC

Inactive Ingredients

Ingredient Name

Stre ng th

Wa ter (UNII: 0 59 QF0 KO0 R)

Ammo nium La ureth-5 Sulfa te (UNII: 43ZIH8 9 I48 )

Ammo nium La uryl Sulfa te (UNII: Q7AO2R1M0 B)

Co ca mido pro pyl Beta ine (UNII: 5OCF3O11KX)

Co co Mo no etha no la mide (UNII: C8 0 6 8 4146 D)

Ma g nesium Aluminum Silica te (UNII: 6 M3P6 4V0 NC)

Hypro mello se, Unspecified (UNII: 3NXW29 V3WO)

Mentho l, Unspecified Fo rm (UNII: L7T10 EIP3A)

DMDM Hyda nto in (UNII: BYR0 546 TOW)

Citric Acid Mo no hydra te (UNII: 29 6 8 PHW8 QP)

So dium Chlo ride (UNII: 451W47IQ8 X)

Fd&C Blue No . 1 (UNII: H3R47K3TBD)

D&C Red No . 3 3 (UNII: 9 DBA0 SBB0 L)

Product Characteristics

Color

GREEN

S core

S hap e

S iz e

Flavor

Imprint Code

Contains

Packag ing

#

Item Code

Package Description

Marketing Start

Date

Marketing End

Date

1

NDC:41250 -545-

325 mL in 1 BOTTLE, PLASTIC; Type 0 : No t a Co mbinatio n

Pro duc t

0 5/11/20 10

Marketing Information

Marke ting Cate gory

Application Numbe r or Monograph Citation

Marke ting Start Date

Marke ting End Date

OTC MONOGRAPH FINAL

pa rt358 H

0 5/11/20 10

Labeler -

Meijer Distribution, INC (006959555)

Registrant -

SIGAN INDUST RIES INC. (255106239)

Establishment

Name

Ad d re s s

ID/FEI

Busine ss Ope rations

SIGAN INDUSTRIES INC.

25510 6 239

MANUFACTURE(41250 -545)

Revised: 5/2019

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