DANDRUFF- pyrithione zinc shampoo
Publix

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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Option claims

Dandruff Care for Great Looking Hair

This product helps relieve scalp dryness, itch, irritation and helps prevent flakes.

Dry Scalp Care and Shiny Clean hair

With moisturizes, it soothes the scalp while cleansing and conditioning the hair
pH balanced for everydat use-even for permed or color-treated hair

Active ingredient

Pyrithione zinc 1%

Purpose

Anti-dandruff

Use

Use hlep prevent recurrence of flaking and iching associated with dandruff

Warnings

For external use only

When using this product

do not get into eyes. If contact occurs, rinse eyes thoroughly with water.

stop use

Stop use and ask a doctor if

condition worsens or does not improve after reqular use as directed

Keep out of reach of children

Keep out of reach of children. If swallowed, get medical help or contact 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

Inactive ingredients

Inactive ingredientswater, sodium laureth sulfate, sodium lauryl sulfate, amodimethicone, cocamide MEA, zinc carbonate, glycol distearate, sodium xylenesulfonate, fragrance, cetyl alcohol, guar 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

Dislcaimer

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

Adverse reactions

DISTRIBUTED BY PUBLIS SUPER MARKETS, INC

3300 PUBLIX CORPORATE PARKWAY

LAKELAND, FL 33811

publix.com

Publix Guarantee

Complete satisfaction or your money back

Principal display panel

Publix

PYRITHIONE ZINC

dryscalp

DANDRUFF

SHAMPOO

COMPARE TO HEAD + SHOULDERS

14.2 FL OS

(420 mL)

image description

DANDRUFF
pyrithione zinc shampoo

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:56062-218
Route of Administration	TOPICAL	DEA Schedule

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
PYRITHIONE ZINC (PYRITHIONE ZINC)	PYRITHIONE ZINC	1 g in 100 mL

Inactive Ingredients
Ingredient Name	Strength
WATER
SODIUM LAURETH SULFATE
SODIUM LAURYL SULFATE
AMODIMETHICONE (800 CST)
COCO MONOETHANOLAMIDE
ZINC CARBONATE
GLYCOL DISTEARATE
SODIUM XYLENESULFONATE
CETYL ALCOHOL
GUAR HYDROXYPROPYLTRIMONIUM CHLORIDE (1.7 SUBSTITUENTS PER SACCHARIDE)
MAGNESIUM SULFATE
SODIUM CHLORIDE
SODIUM BENZOATE
MAGNESIUM CARBONATE HYDROXIDE
BENZYL ALCOHOL
ALMOND OIL
TRIDECETH-12
CETRIMONIUM CHLORIDE
SODIUM HYDROXIDE
METHYLCHLOROISOTHIAZOLINONE
METHYLISOTHIAZOLINONE

Packaging
#	Item Code	Package Description
1	NDC:56062-218-15	420 mL in 1 BOTTLE, PLASTIC

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part358H	01/13/2009

Labeler - Publix (006922009)

Registrant - Vi-Jon (790752542)

Establishment
Name	Address	ID/FEI	Business Operations
Vi-Jon		088520668	manufacture(56062-218)

Revised: 10/2012

Document Id: be8b104d-6cf7-4ea4-9296-491dd43ba25d

Set id: a398e198-f1b5-4407-878a-b5971eb2e442

Version: 2

Effective Time: 20121024

Publix