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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Claims

Dandruff Care for Great Looking Hair

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

Clean Manageable Hair Everyday

  • Dual formula cleans and conditions hair in one easy step
  • Gentle and pH balanced for everyday use - even for permed or color-treated hair

Active ingredients

Active Ingredient

Pyrithione zinc 1%

Purpose

Purpose

Anti-dandruff

Use

Use helps prevent recurrence of flaking and itching associated with dandruff

Warnings

Warnings

For external use only

When using this product

When using this product

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

Stop Use

Stop use and ask a doctor if

  • condition worsens or does not improve after regular use as directed

Keep out of reach of children

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

Directions

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, cocamideMEA, zinc carbonate, glycol distearate, amodimethicone, fragrance, cetyl alcohol, guar hydroxypropyltrimonium chloride, magnesium sulfate, sodium benzoate, magnesium carbonate hydroxide, ammonium laureth sulfate, benzyl alcohol, sodium chloride, methylchloroisothiazolinone, methylisothiazolinone, sodium xylenesulfonate, trideceth-12, cetrimonium chloride, sodium hydroxide, yellow 10, blue 1, red 4

Adverse Reactions

Distributed by: American sales Company

4201 Walden Avenue, Lancaster, NY 14086

1-877-846-9949

Quality guaranteed or your money back

Principal Display Panel

CAREONE

everyday clean 2 in 1

Dandruff

shampoo plus

conditioner

for normal hair

pyrithione zinc

14.2 FL OZ (420 mL)

image description

DANDRUFF 
pyrithione zinc shampoo
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:41520-311
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
PYRITHIONE ZINC (PYRITHIONE ZINC) PYRITHIONE ZINC1 g  in 100 mL
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) 
MAGNESIUM SULFATE 
SODIUM BENZOATE 
MAGNESIUM CARBONATE HYDROXIDE 
AMMONIUM LAURETH-3 SULFATE 
BENZYL ALCOHOL 
SODIUM CHLORIDE 
METHYLCHLOROISOTHIAZOLINONE 
METHYLISOTHIAZOLINONE 
SODIUM XYLENESULFONATE 
TRIDECETH-12 
CETRIMONIUM CHLORIDE 
SODIUM HYDROXIDE 
D&C YELLOW NO. 10 
FD&C BLUE NO. 1 
FD&C RED NO. 4 
Packaging
#Item CodePackage Description
1NDC:41520-311-15420 mL in 1 BOTTLE, PLASTIC
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart358H12/20/2010
Labeler - American Sales Company (809183973)
Registrant - Vi-Jon (790752542)
Establishment
NameAddressID/FEIBusiness Operations
Vi-Jon088520668manufacture(41520-311)

Revised: 08/2012
 
American Sales Company