DANDRUFF  - pyrithione zinc shampoo 
Topco Associates

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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Dandruff Care for Great Looking Hair
Top Care Dandruff Shampoo Fresh Mint formula
helps relieve scalp dryness, itch, irritation and
helps prevent flakes, for clean manageable hair every day

Active ingredient
Pyritione 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, zinc carbonate, glycol distearate, fragrance.,
amodimethicone, cetyl alcohol, guar hydroxypropyltrimonium chloride, menthol, magnesium sulfate, sodium benzoate, magnesium carbonate hydroxide,
ammonioum laureth sulfate, benzyl alcohol, sodium chloride, methylchloroisothiazolinone, methylisothiazolinone, sodium xylenesulfante,
trideceth-12, cetrimonium chloride, sodium hydroxide, yellow 10, blue1, red 4

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

  DISTRIBUTED BY TOPCO ASSOCIATES LLC
7711 GROSS POINT ROAD, SKOKIE, IL 60077
QUESTIONS? 1-888-423-0139

TOPCARE
GENTLE
dandruff
shampoo
with pyrithione zinc
a cool refreshing
sensation and
hair is left clean and
manageable
FRESH MINT
COMPARE TO
HEAD + SHOULDERS
14.2 FL OZ
(420 mL)
image of principal display panel

DANDRUFF 
pyrithione zinc shampoo
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:36800-309
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
PYRITHIONE ZINC (PYRITHIONE ZINC) PYRITHIONE ZINC1 kg  in 100 L
Inactive Ingredients
Ingredient NameStrength
WATER 
SODIUM LAURETH SULFATE 
SODIUM LAURYL SULFATE  
COCO MONOETHANOLAMIDE 
ZINC CARBONATE 
GLYCOL DISTEARATE 
AMODIMETHICONE (800 CST) 
CETYL ALCOHOL 
GUAR HYDROXYPROPYLTRIMONIUM CHLORIDE (1.7 SUBSTITUENTS PER SACCHARIDE) 
MENTHOL 
MAGNESIUM SULFATE 
SODIUM BENZOATE 
MAGNESIUM CARBONATE HYDROXIDE 
AMMONIUM LAURETH-3 SULFATE 
BENZYL ALCOHOL 
SODIUM CHLORIDE 
METHYLCHLOROISOTHIAZOLINONE 
METHYLISOTHIAZOLINONE 
SODIUM XYLENESULFONATE 
CETRIMONIUM CHLORIDE 
SODIUM HYDROXIDE 
D&C YELLOW NO. 10 
FD&C BLUE NO. 1 
FD&C RED NO. 4 
Product Characteristics
Color    Score    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMultilevel Packaging
1NDC:36800-309-150.42 L in 1 BOTTLE, PLASTICNone

Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart358H02/10/2011

Labeler - Topco Associates (006935977)
Registrant - Vi-Jon (790752542)
Establishment
NameAddressID/FEIOperations
Vi-Jon088520668manufacture

Revised: 07/2012 Topco Associates