DRY SCALP CARE - pyrithione zinc shampoo
OnPoint, Inc

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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Drug Facts

DRY SCALP
DANDRUFF
SHAMPOO

Active ingredient
Pyrithione zinc 1%

Purpose
Anti-dandruff

Use helps prevent recurrence of flaking and itching 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 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.

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 leat twice a week or as directed by a doctor

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

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

Distributed by OnPoint, Inc
2 Paragon Drive
Montvale, NJ 07645

AMERICA'S
CHOICE
2 in 1
DRY SCALP
DANDRUFF
SHAMPOO
pyrithione zinc
anti-dandruff
shampoo
plus conditioner
COMPARE TO
HEAD + SHOULDERS
DRY SCALP CARE
DANDRUFF SHAMPOO
+ CONDITIONER
14.2 FL OZ
(420 mL)

DRY SCALP CARE
pyrithione zinc shampoo

Product Information
Product Type	HUMAN OTC DRUG LABEL	Item Code (Source)	NDC:51143-296
Route of Administration	TOPICAL	DEA Schedule

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

Ingredient Name	Strength
Inactive Ingredients
WATER
SODIUM LAURETH SULFATE
SODIUM LAURYL SULFATE
COCO MONOETHANOLAMIDE
AMODIMETHICONE (800 CST)
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
AMMONIUM LAURETH-3 SULFATE
TRIDECETH-12
CETRIMONIUM CHLORIDE
CITRIC ACID MONOHYDRATE
METHYLCHLOROISOTHIAZOLINONE
METHYLISOTHIAZOLINONE

#	Item Code	Package Description
Packaging
1	NDC:51143-296-15	0.42 L in 1 BOTTLE, PLASTIC
2	NDC:51143-296-35	700 L in 1 BOTTLE, PLASTIC

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part358H	03/04/1998

Labeler - OnPoint, Inc (001367366)

Registrant - Vi-Jon (790752542)

Name	Address	ID/FEI	Business Operations
Establishment
Vi-Jon		790752542	manufacture

Revised: 7/2012

Document Id: 99fd6c43-50e9-4cec-9ab0-72e56f823016

Set id: cb4d700b-8045-40ba-9017-eea25a7c5a1e

Version: 1

Effective Time: 20120702

OnPoint, Inc