SOFT WHISPER DANDRUFF- pyrithione zinc shampoo

Soft Whisper Dandruff by

Drug Labeling and Warnings

Soft Whisper Dandruff by is a Otc medication manufactured, distributed, or labeled by A.P. Deauville, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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:

INGREDIENTS AND APPEARANCE

SOFT WHISPER DANDRUFF 
pyrithione zinc shampoo

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 42913-020
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
PYRITHIONE ZINC (UNII: R953O2RHZ5) (PYRITHIONE ZINC - UNII:R953O2RHZ5)	PYRITHIONE ZINC	10 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 42913-020-00	426 mL in 1 BOTTLE; Type 0: Not a Combination Product	10/05/2017

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part358H	10/05/2017

Labeler - A.P. Deauville, LLC (100941835)

Establishment
Name	Address	ID/FEI	Business Operations
A.P. Deauville, LLC		100941835	manufacture(42913-020)