PrimaDerm Anti-dandruff

Dosage form: shampoo
Ingredients: Pyrithione Zinc 1mg in 100mL
Labeler: Derma Sciences
NDC Code: 58111-105

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

1% Zinc Pyrithione

Purpose

Anti-dandruff

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

Warnings
  • For external use only

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

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

Keep out of reach of children.

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

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.

Questions?

1-800-445-7627

Principal Display Panel

 

 

PrimaDerm®

Anti-Dandruff Shampoo

NDC 58111-105-08

  • Fast Acting Formula
  • pH Balanced
  • Latex Free

Manufactured for Derma Sciences, Inc.

Princeton, NJ 08540

Questions? 1-800-445-7627

Visit our web site at

www.dermasciences.com

8 fl oz (240 mL)

S105-8Z

PRIMADERM ANTI-DANDRUFF 
pyrithione zinc shampoo
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58111-105
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:58111-105-08240 mL in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart358H08/01/2005
Labeler - Derma Sciences (200564891)

Revised: 06/2010
 
Derma Sciences

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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