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Dandruff by Topco Associates LLC

Dosage form: shampoo
Ingredients: PYRITHIONE ZINC 1kg in 100L
Labeler: Topco Associates LLC
NDC Code: 36800-281

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.

Drug Facts

Drug Facts

Top Care

Dandruff Care for Great Looking Hair

TopCare Dandruff Shampoo Dry Scalp formula

helps relieve scalp dryness, itch irritation and

helps prevent flakes for clean, manageable hair every day

Active Ingredient

Pyrithione zince 1%

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 water.

Stop use and ask a doctor

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 Direction
  • 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, amodimethicone, zinc carbonate, glycol distearate, sodium xylenesulfonate, fragrance, cetyl alcohol, guar 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

Disclaimer

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

Adverse reactions

DISTRIBUTED BY TOPCO ASSOCIATES LLC

7711 GROSS POINT ROAD, SKOKIE, IL 60077

Questions

Question? 1-888-423-0139 topcare@topco.com

Principal display panel

TopCare

GENTLE

Dandruff

Shampoo

with Pyrithione Zinc

Hair is cleaned and

conditioned while

moisturizers help

soothe the scalp

DRY
SCALP

COMPARE TO

HEAD + SHOULDERS

14.2 FL OZ

(420 mL)

DANDRUFF 
pyrithione zinc shampoo
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:36800-281
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 
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 
Packaging
#Item CodePackage Description
1NDC:36800-281-150.420 L in 1 BOTTLE, PLASTIC
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart358H05/28/2002
Labeler - Topco Associates LLC (006935977)
Registrant - Vi-Jon (790752542)
Establishment
NameAddressID/FEIOperations
Vi-Jon088520668manufacture(36800-281)

Revised: 08/2012
 
Topco Associates LLC

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Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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