Medication Guide App

System TLC Anti-dandruff

Dosage form: shampoo
Ingredients: Pyrithione Zinc 1mg in 100mL
Labeler: Chester Packaging, LLC
NDC Code: 12462-300

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

Active ingredient

Pyrithione Zinc 1%

Purpose

Anti-dandruff

Use
  • Helps prevent recurrence of flaking and itching associated with dandruff

Warnings
  • For external use only
  • Not for use on larger areas of the body.

When using this product
  • avoid contact with eyes. If this occurs, rinse thoroughly with water.

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

Directions

For best results, use at least twice a week or as directed by a doctor. Wet hair thoroughly. Massage shampoo into your scalp for several minutes. Rinse and repeat. For maximum dandruff control, use everytime you shampoo. SHAKE WELL before use.

Inactive ingredients

Water, Ammonium Lauryl Sulfate, Ammonium Laureth Sulfate, Cocamidopropyl Betaine, Cocamide DEA, Lauramide DEA, Glycol Monosterate, Sodium Lauryl Sulfate, DMDM Hydantoin, Sodium Chloride, Fragrance, Citric Acid, FD&C Blue No.1.

Principal Display Panel

Anti-Dandruff Shampoo

System TLC®

Anti-Dandruff Shampoo

Fast Acting Formula

pH Balanced

Pleasant Fragrance


Shake Well

Order Number 570-8

8 U. S. Fl. Oz. (237 ml)

Chester Packaging

SYSTEM TLC ANTI-DANDRUFF 
pyrithione zinc shampoo
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:12462-300
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Pyrithione Zinc (Pyrithione Zinc) Pyrithione Zinc1 mg  in 100 mL
Inactive Ingredients
Ingredient NameStrength
Water 
Ammonium Lauryl Sulfate 
Cocamidopropyl Betaine 
COCAMIDE DIETHANOLAMINE 
LAURIC DIETHANOLAMIDE 
Glycol Stearate 
Sodium Lauryl Sulfate 
DMDM HYDANTOIN 
Sodium Chloride 
Citric Acid Monohydrate 
FD&C BLUE NO. 1 
Packaging
#Item CodePackage Description
1NDC:12462-300-08236 mL in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart358H01/01/2005
Labeler - Chester Packaging, LLC (004237806)

Revised: 06/2010
 
Chester Packaging, 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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