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Soft Whisper Dandruff

Dosage form: shampoo
Ingredients: PYRITHIONE ZINC 10mg in 1mL
Labeler: A.P. Deauville, LLC
NDC Code: 42913-020

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.

Soft Whisper Dandruff Shampoo

Drug Facts

Active Ingredients

Pyrithione zinc 1.0%

Purpose

Anti-Dandruff

Uses
  • Helps eliminate itching and flaking associated with dandruff.

Warnings

For external use only.

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

Stop use and ask doctor if
  • Condition worsens or does not improve after regular use

Keep out of reach of children. 

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

Directions
  • Wet hair and massage into scalp. Rinse thoroughly. Repeat if desired. 
  • For best results use at least twice a week or as directed by a doctor.

Inactive Ingredients

Water, Sodium laureth sulfate, sodium lauryl sulfate, cocamidopropyl betaine, sodium chloride, glycol stearate cetyl alcohol, fragrance, polyquaternium-10, citric acid, methylchloroisothiazolinone, methylisothiazolinone

Questions or comments?

Call us at (732)545-0200

Package Labeling:

SOFT WHISPER DANDRUFF 
pyrithione zinc shampoo
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:42913-020
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
PYRITHIONE ZINC (PYRITHIONE ZINC) PYRITHIONE ZINC10 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
SODIUM LAURETH SULFATE 
WATER 
SODIUM LAURYL SULFATE 
COCAMIDOPROPYL BETAINE 
SODIUM CHLORIDE 
CITRIC ACID MONOHYDRATE 
METHYLCHLOROISOTHIAZOLINONE 
METHYLISOTHIAZOLINONE 
Packaging
#Item CodePackage Description
1NDC:42913-020-00426 mL in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart358H10/05/2017
Labeler - A.P. Deauville, LLC (100941835)
Establishment
NameAddressID/FEIOperations
A.P. Deauville, LLC100941835manufacture(42913-020)

Revised: 12/2017
 
A.P. Deauville, 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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