MEDICATED DANDRUFF- selenium sulfide shampoo

Medicated Dandruff by

Drug Labeling and Warnings

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

Drug Details [pdf]

ACTIVE INGREDIENT

Active ingredient
Selenium sulfide 1%

Purpose
Anti-Dandruff

INDICATIONS & USAGE

Use for relief of itching and flaking associated with dandruff and seborrheic dermatitis and to help prevent reoccurrence

WARNINGS

Warnings
For external use only

Ask a doctor before use if you have seborrheic dermatitis in areas other than the scalp

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, bet medical help or contact a Poison Control Center right away.

DOSAGE & ADMINISTRATION

Directions Shake well wet hair, massage onto scalp, rinse thoroughly
for best results use at least twice a week or as directed b a doctor

OTHER SAFETY INFORMATION

Other information for color-treated or permed hair, rinse extra thoroughly

INACTIVE INGREDIENT

Inactive ingredients water, ammonium laury sulfate, TEA-lauryl sulfate, ammonium laureth sulfate,  cocamidopropyl betaine, magnesium aluminum silicate, fragrance,
menthol, cocamide DEA, DMDM hydantoin citric acid, hydroxypropyl methylcellulose, xanthan gum, cellulose gum, FD+C blue no. 1, D+C red no 33, sodium citrate, sodium chloride.

ADVERSE REACTIONS

PACKAGED FOR DOLGENCORP, LLC
100 MISSION RIDGE, GOODLETTSVILLE, TN 37072 USA
visit us at Rexall.com or call 1-866-4-REXALL

PRINCIPAL DISPLAY PANEL

Since 1903
Rexall
MAXIMUM
DANDRUFF
CONTROL
SHAMPOO
Selenium Sulfide
Dandruff Shampoo
For a healthier scalp and hair
Helps prevent flakes
11 FL OZ (325 mL)

INGREDIENTS AND APPEARANCE

MEDICATED DANDRUFF 
selenium sulfide shampoo

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 55910-246
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SELENIUM SULFIDE (UNII: Z69D9E381Q) (SELENIUM SULFIDE - UNII:Z69D9E381Q)	SELENIUM SULFIDE	1 kg  in 100 L

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
AMMONIUM LAURYL SULFATE (UNII: Q7AO2R1M0B)
TROLAMINE LAURYL SULFATE (UNII: E8458C1KAA)
AMMONIUM LAURETH-3 SULFATE (UNII: 896SJ235FN)
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)
MAGNESIUM ALUMINUM SILICATE (UNII: 6M3P64V0NC)
MENTHOL (UNII: L7T10EIP3A)
COCO DIETHANOLAMIDE (UNII: 92005F972D)
DMDM HYDANTOIN (UNII: BYR0546TOW)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
HYPROMELLOSES (UNII: 3NXW29V3WO)
XANTHAN GUM (UNII: TTV12P4NEE)
CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
D&C RED NO. 33 (UNII: 9DBA0SBB0L)
SODIUM CITRATE (UNII: 1Q73Q2JULR)
SODIUM CHLORIDE (UNII: 451W47IQ8X)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 55910-246-39	.325 L in 1 BOTTLE, PLASTIC

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part358H	11/03/2011

Labeler - Dolgencorp.LLC (068331990)

Registrant - Vi-Jon (088520668)

Establishment
Name	Address	ID/FEI	Business Operations
Vi-Jon		088520668	manufacture