DANDRUFF- selenium sulfide shampoo

Dandruff by

Drug Labeling and Warnings

Dandruff by is a Otc medication manufactured, distributed, or labeled by Meijer Distribution, Vi-Jon. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient

Selenium sulfide 1%

Purpose

Anti-dandruff, Anti-seborrheic dermatitis

Use

helps prevent recurrence of itching, irritation, redness, flaking and scaling associated with dandruff and seborrheic dermatitis

Warnings

For external use only

Ask a doctor before use if

condition covers a large area of the body

When using this product

• do not get into 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 right away.

Directions

• shake well
• for maximum dandruff control, use every time you shampoo
• wet hair, massage onto scalp, rinse, repeat if desired
• for best results use at least twice a week or as directed by a doctor
• if used on bleached, gray, tinted or permed hair, rinse for at least 5 minutes

Inactive ingredients

water, ammonium laureth sulfate, ammonium lauryl sulfate, glycol distearate, cocamide MEA, ammonium xylenesulfonate, sodium citrate, fragrance, amodimethicone, cetyl alcohol, sodium chloride, citric acid, sodium benzoate, stearyl alcohol, disodium EDTA, hydrogen peroxide, hydroxypropyl methylcellulose, methylchlorisothiazolinone, methylisothiazolinone, red 4

SPL UNCLASSIFIED SECTION

Helps fight dandruff from the 1st wash.

Contains 1% selenium sulfide to help reduct the symptoms of dandruff and seborrheic dermatitis: itching, Flaking, Scaling, irritation and redness.

*This product is not manufactured or distributed by Procter + Gamble, distributor of Head + Shoulders Clinical Strength Dandruff Shampoo

DIST. BY MEIJER DISTRIUBTION, INC.

2929 WALKER AVE NW

GRAND RAPIDS, MI 49544

www.meijer.com

Principal Display Panel

Meijer Advanced Solution dandruff shampoo

dandruff and seborrheic dermatitis shampoo with selenium sulfide

Maximum Strength

helps relieve even stubborn dandruff

COMPARE TO THE ACTIVE INGREDIENT OF HEAD + SHOULDERS CLINICAL STRENGTH*

14.2 FL OZ (420 mL)

816.000/816AC

INGREDIENTS AND APPEARANCE

DANDRUFF 
selenium sulfide shampoo

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 41250-816
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-3 SULFATE (UNII: 896SJ235FN)
AMMONIUM LAURYL SULFATE (UNII: Q7AO2R1M0B)
GLYCOL DISTEARATE (UNII: 13W7MDN21W)
COCO MONOETHANOLAMIDE (UNII: C80684146D)
AMMONIUM XYLENESULFONATE (UNII: 4FZY6L6XCM)
SODIUM CITRATE (UNII: 1Q73Q2JULR)
AMODIMETHICONE (800 CST) (UNII: 363Z2T48P7)
CETYL ALCOHOL (UNII: 936JST6JCN)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
SODIUM BENZOATE (UNII: OJ245FE5EU)
STEARYL ALCOHOL (UNII: 2KR89I4H1Y)
EDETATE DISODIUM (UNII: 7FLD91C86K)
HYDROGEN PEROXIDE (UNII: BBX060AN9V)
HYPROMELLOSES (UNII: 3NXW29V3WO)
METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN)
METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)
FD&C RED NO. 4 (UNII: X3W0AM1JLX)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 41250-816-15	420 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	06/01/2013

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part358H	06/01/2013

Labeler - Meijer Distribution (006959555)

Registrant - Vi-Jon (790752542)

Establishment
Name	Address	ID/FEI	Business Operations
Vi-Jon		790752542	manufacture(41250-816)