SOFT WHISPER DANDRUFF- pyrithione zinc shampoo 
A.P. Deauville, LLC

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.

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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:

Label

SOFT WHISPER DANDRUFF 
pyrithione zinc shampoo
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:42913-020
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
PYRITHIONE ZINC (UNII: R953O2RHZ5) (PYRITHIONE ZINC - UNII:R953O2RHZ5) PYRITHIONE ZINC10 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
SODIUM LAURETH SULFATE (UNII: BPV390UAP0)  
WATER (UNII: 059QF0KO0R)  
SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN)  
METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:42913-020-00426 mL in 1 BOTTLE; Type 0: Not a Combination Product10/05/201703/15/2023
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart358H10/05/201703/15/2023
Labeler - A.P. Deauville, LLC (100941835)
Establishment
NameAddressID/FEIBusiness Operations
A.P. Deauville, LLC100941835manufacture(42913-020)

Revised: 11/2020
Document Id: b3adf278-0588-2d54-e053-2a95a90a61f1
Set id: 15c93b2f-60c8-42ae-a21c-8523c0d8be7e
Version: 5
Effective Time: 20201109
 
A.P. Deauville, LLC