DANDRUFF   - pyrithione zinc shampoo 
American Sales Company

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
This product helps relieves scalp dryness,
itch, irritation and helps prevent flakes.
A Refreshing Sensation and Clean Manageable Hair
•Contains mint for a cool, refreshing sensation
  and leaves hair clean and manageable
•pH balanced for everyday use - even
  for permed or color-treated hair

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

Distributed  by: American Sales Company
4201 Walden Avenue, Lancaster, NY 14086
Quality guaranteed or your money back

CAREONE
refreshingly cool
Dandruff
shampoo
invigorates
pyrithione znc
14.2 FL OZ (420 mL)
image of principal display panel

DANDRUFF  
pyrithione zinc shampoo
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:41520-309
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 
AMMONIUM LAURETH-3 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:41520-309-150.419 L in 1 BOTTLE, PLASTICNone

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

Labeler - American Sales Company (809183973)
Registrant - Vi-Jon (790752542)
Establishment
NameAddressID/FEIOperations
Vi-Jon088520668manufacture

Revised: 07/2012 American Sales Company