Zincon Medicated Dandruff

Dosage form: shampoo
Ingredients: PYRITHIONE ZINC 0.01g in 1mL
Labeler: Ultimark Products LLC
NDC Code: 51545-250

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.

Zincon Medicated Dandruff Shampoo

Active Ingredient

Pyrithione zinc 1%

Purpose

Anti-dandruff

Uses
  • reduces and helps eliminate scalp itching, flaking and scaling associated with dandruff and seborrheic dermatitis. 

Warnings

For external use only.

Ask a doctor before use if you have

a condition that covers a large area of the body.

When using this product

avoid contact with the eyes. If contact occurs, rinse eyes thoroughly with water.

Stop use and ask a doctor if
  • condition worsens
  • condition does not improve after regular use of this product as directed.

Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center right away.

Directions
  • shake well
  • wet hair, apply to scalp and massage vigorously
  • rinse and repeat
  • for best results, use at least twice a week or as directed by a doctor
  • do not use on children under 2 years of age, except as directed by a doctor.

Inactive ingredients

Citric acid, cocamide MEA, deionized water, FD&C Blue 1, fragrance, glycol distearate, magnesium aluminum silicate, Methylchloroisothiazolinone, Methylisothiazolinone, propylene glycol, sodium chloride, sodium laureth sulfate, sodium lauryl sulfate.

Questions?

1-800-220-0151

www.denorex.net

PRINCIPAL DISPLAY PANEL

Pyrithione Zinc
Zincon®
MEDICATED
 
DANDRUFF SHAMPOO

8 fl.oz. (118ml)

ZINCON MEDICATED DANDRUFF 
pyrithione zinc shampoo
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51545-250
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
PYRITHIONE ZINC (PYRITHIONE ZINC) PYRITHIONE ZINC0.01 g  in 1 mL
Inactive Ingredients
Ingredient NameStrength
CITRIC ACID MONOHYDRATE 
COCO MONOETHANOLAMIDE 
WATER 
FD&C BLUE NO. 1 
GLYCOL DISTEARATE 
MAGNESIUM ALUMINUM SILICATE 
METHYLCHLOROISOTHIAZOLINONE 
METHYLISOTHIAZOLINONE 
PROPYLENE GLYCOL 
SODIUM CHLORIDE 
SODIUM LAURETH SULFATE 
SODIUM LAURYL SULFATE 
Packaging
#Item CodePackage Description
1NDC:51545-250-08118 mL in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart358H11/01/2010
Labeler - Ultimark Products LLC (964734078)

Revised: 07/2012
 
Ultimark Products LLC

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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