FDA.reportPublic FDA data

Soft Whisper Dandruff

Manufacturer
A.P. Deauville, LLC
Effective date
2020-11-09
Label type
HUMAN OTC DRUG LABEL
Version
5
Source
legacy-cache
Hydrated at
2026-08-01 23:08:17

Label at a glance#

ProductSoft Whisper Dandruff
Active ingredientPYRITHIONE ZINC
Label structure7 sections

Indications and uses

Helps eliminate itching and flaking associated with dandruff.

Dosage and administration

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.

Label contents#

Full prescribing information#

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Pyrithione zinc 1.0%

Purpose

OTC - PURPOSE SECTION

Anti-Dandruff

Uses

INDICATIONS & USAGE SECTION

  • Helps eliminate itching and flaking associated with dandruff.

Warnings

WARNINGS SECTION

For external use only.

When using this product

OTC - WHEN USING SECTION

  • Avoid contact with the eyes. If contact occurs, rinse eyes thoroughly with water.

Stop use and ask doctor if

OTC - STOP USE SECTION

  • Condition worsens or does not improve after regular use

Keep out of reach of children. 

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

Directions

DOSAGE & ADMINISTRATION SECTION

  • 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

INACTIVE INGREDIENT SECTION

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?

OTC - QUESTIONS SECTION

Call us at (732)545-0200

Package Labeling:

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LabelLabel

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 10 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
42913-02042913-020-00

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 9 matching rows.

Name, UNII, Kind table
NameUNIIKind
SODIUM LAURETH SULFATEBPV390UAP0IACT
WATER059QF0KO0RIACT
SODIUM LAURYL SULFATE368GB5141JIACT
COCAMIDOPROPYL BETAINE5OCF3O11KXIACT
SODIUM CHLORIDE451W47IQ8XIACT
CITRIC ACID MONOHYDRATE2968PHW8QPIACT
METHYLCHLOROISOTHIAZOLINONEDEL7T5QRPNIACT
METHYLISOTHIAZOLINONE229D0E1QFAIACT
PYRITHIONE ZINCR953O2RHZ5ACTIB

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
b3adf278-0588-2d54-e053-2a95a90a61f115c93b2f-60c8-42ae-a21c-8523c0d8be7e2020-11-09WarningsExact identifier
spl id: b3adf278-0588-2d54-e053-2a95a90a61f1
spl set id: 15c93b2f-60c8-42ae-a21c-8523c0d8be7e

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.