HEAD AND SHOULDERS REFRESH MEN- pyrithione zinc lotion/shampoo
Procter & Gamble Manufacturing Co.

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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Head and Shoulders®
Refresh Men

Drug Facts

Active ingredient

Pyrithione zinc 1%

Purpose

Anti-dandruff

Uses

helps prevent recurrence of flaking and itching associated with dandruff.

Warnings

For external use only.

When using this product

avoid contact with 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 of this product as directed.

Keep this and all drugs out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions

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

Inactive ingredients

Water, sodium laureth sulfate, sodium lauryl sulfate, zinc carbonate, sodium chloride, fragrance, sodium xylenesulfonate, cocamidopropyl betaine, dimethicone, sodium benzoate, guar hydroxypropyltrimonium chloride, magnesium carbonate hydroxide, methylchloroisothiazolinone, methylisothiazolinone, blue 1, red 33.

Questions (or comments)?

1-800-723-9569

Dist. by PROCTER & GAMBLE, CINCINNATI, OH 45202

PRINCIPAL DISPLAY PANEL - 700 mL Bottle Label

head &
shoulders®

pyrithione zinc
dandruff shampoo

MEN

IMPROVES HAIR & SCALP
HEALTH. GUARANTEED.*

REFRESH

cools the scalp for an exhilarating sensation

23.7 FL OZ (700 mL)

98756932

Principal Display Panel - 700 mL Bottle Label

HEAD AND SHOULDERS REFRESH MEN
pyrithione zinc lotion/shampoo

Product Information
Product Type	HUMAN OTC DRUG LABEL	Item Code (Source)	NDC:37000-340
Route of Administration	TOPICAL	DEA Schedule

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
Pyrithione Zinc (Pyrithione Zinc)	Pyrithione Zinc	0.01 g in 1 mL

Ingredient Name	Strength
Inactive Ingredients
water
sodium laureth sulfate
sodium lauryl sulfate
zinc carbonate
sodium chloride
sodium xylenesulfonate
cocamidopropyl betaine
dimethicone
sodium benzoate
magnesium carbonate hydroxide
methylchloroisothiazolinone
methylisothiazolinone
FD&C blue no. 1
D&C red no. 33
guar hydroxypropyltrimonium chloride (1.7 substituents per saccharide)

#	Item Code	Package Description
Packaging
1	NDC:37000-340-42	420 mL in 1 BOTTLE, PLASTIC
2	NDC:37000-340-70	700 mL in 1 BOTTLE, PLASTIC

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC MONOGRAPH FINAL	part358H	01/01/2012

Labeler - Procter & Gamble Manufacturing Co. (004238200)

Revised: 5/2012

Document Id: 88ce3d68-b9f3-4a0a-abc8-e39f9d240371

Set id: 9ae9bf49-a7a0-4b06-b59d-2f28f2ddccc4

Version: 1

Effective Time: 20120531

Procter & Gamble Manufacturing Co.

Head and Shoulders® Refresh Men