DANDRUFF- pyrithione zinc shampoo

Dandruff by

Drug Labeling and Warnings

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

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Dry Scalp Dandruff Care
for Great Looking Hair
With moisturizers, it soothes the scalp while
cleaning ad conditioning the dandruff.

ACTIVE INGREDIENT

Active Ingredient
Pyrithione zinc

Purpose
Anti-dandruff

INDICATIONS & USAGE

Use helps prevent recurrence of flaking and itching associated with dandruff

WARNINGS

Warnings
For external use only

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.

DOSAGE & ADMINISTRATION

Directions
shake well
for maximum dandruff control, use every time you shampoo
wet hair, massage onto the scalp, rinse, repeat if desired
for best results use at least twice a week or as directed by a doctor

INACTIVE INGREDIENT

Inactive ingredients water, sodium laureth sulfate, sodium lauryl sulfate, amodimethicone, cocamide MEA, zinc carbonate, glycol distearate,
sodium hydroxypropyltrimonium chloride, magnesium sulfate, sodium chloride, sodium benzoate, magnesium carbonate hydroxide,
benzyl alcohol, prunus amygdalus dulcis (sweet almond)oil, trideceth-12, cetrimonium chloride, sodium hydroxide,
methylchloroisothiazolinone, methylisothiazolinone

SPL UNCLASSIFIED SECTION

This product is not manufactured or distributed by
Procter + Gamble, distributor of Head + Shoulders

ADVERSE REACTIONS

DISTRIBUTED BY
WAKFERN FOOD CORPORATION
5000 RIVERSIDE DRIVE
KEASBEY, NJ 08832
1-800-SHOPRITE
www.shoprite.com

PRINCIPAL DISPLAY PANEL

COMPARE TO ACTIVE INGREDIENT
IN HEAD + SHOULDERS
Shop Rite
DANDRUFF
Shampoo
Pyrithione Zinc
DRY SCALP FORMULA
moisturizes and helps
prevent flaking + itching
14.2 FL OZ
(420 mL)

INGREDIENTS AND APPEARANCE

DANDRUFF 
pyrithione zinc shampoo

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 41190-281
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
PYRITHIONE ZINC (UNII: R953O2RHZ5) (PYRITHIONE ZINC - UNII:R953O2RHZ5)	PYRITHIONE ZINC	1 kg  in 100 L

Inactive Ingredients
Ingredient Name	Strength
water (UNII: 059QF0KO0R)
SODIUM LAURETH SULFATE (UNII: BPV390UAP0)
SODIUM LAURYL SULFATE (UNII: 368GB5141J)
GLYCOL DISTEARATE (UNII: 13W7MDN21W)
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)
COCO MONOETHANOLAMIDE (UNII: C80684146D)
ZINC CARBONATE (UNII: EQR32Y7H0M)
BEHENTRIMONIUM CHLORIDE (UNII: X7GNG3S47T)
STEARAMIDOPROPYL DIMETHYLAMINE (UNII: K7VEI00UFR)
MAGNESIUM SULFATE (UNII: DE08037SAB)
SODIUM BENZOATE (UNII: OJ245FE5EU)
BENZYL ALCOHOL (UNII: LKG8494WBH)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
SODIUM CITRATE (UNII: 1Q73Q2JULR)
ZINC CHLORIDE (UNII: 86Q357L16B)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 41190-281-15	0.420 L in 1 BOTTLE, PLASTIC

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part358H	05/11/1992

Labeler - Wakfern Food Corporation (069722418)

Registrant - Vi-Jon (790752542)

Establishment
Name	Address	ID/FEI	Business Operations
Vi-Jon		088520668	manufacture(41190-281)