Dandruff (Pyrithione Zinc) Shampoo [Wakfern Food Corporation] -

DANDRUFF (PYRITHIONE ZINC) SHAMPOO [WAKFERN FOOD CORPORATION]
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NDC	41190-281-15
Set ID	c380e79b-f61b-4368-b152-27681f18b265
Category	HUMAN OTC DRUG LABEL
Packager	Wakfern Food Corporation
Generic Name
Product Class
Product Number
Application Number	PART358H

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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

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

Ingredient Name	Strength
Inactive Ingredients
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)

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

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

Labeler - Wakfern Food Corporation (069722418)

Registrant - Vi-Jon (790752542)

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

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Medic

DANDRUFF (PYRITHIONE ZINC) SHAMPOO [WAKFERN FOOD CORPORATION]

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