DERMAHARMONY 1% PYRITHIONE ZINC- pyrithione zinc soap

Dermaharmony 1% Pyrithione Zinc by

Drug Labeling and Warnings

Dermaharmony 1% Pyrithione Zinc by is a Otc medication manufactured, distributed, or labeled by D3 Development, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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Drug Facts

ACTIVE INGREDIENT

Active ingredient

Pyrithione zinc 1%

PURPOSE

Purpose

Dandruff, Seborrheic dermatitis

INDICATIONS & USAGE

Uses

Controls and reduces the symptoms of dandruff and seborrheic dermatitis.

WARNINGS

Warnings

For external use only

ASK DOCTOR

Ask a doctor before use if you havea condition that covers a large area of the body.

WHEN USING

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

STOP USE

Stop use and ask a doctor ifcondition worsens or does not improve after regular use as directed.

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children.If swallowed, get medical help or contact a Poison Control Center right away.

DOSAGE & ADMINISTRATION

Directions

• Use on affected areas in place of your regular soap
• For best results use at least twice a week or as directed by a doctor
• Work up a lather using warm water and massage into affected areas
• Rinse well

STORAGE AND HANDLING

Other information

• Store at room temperature
• Lot number and expiration date are printed on back panel.

INACTIVE INGREDIENT

Inactive ingredients

Sodium palmate, sodium cocoate*, sodium palm kernelate*, water, glycerin, titanium dioxide, table salt, olive oil, Avena Sativa (oat) kernel flour, tocopheryl acetate (vitamin E), pentasodium pentetate

*May contain this ingredient

QUESTIONS

Questions?

1-800-827-3730

www.dermaharmony.com

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Distributed by:

D3 Development, Inc., Portland, ME 04101

Made in the USA

PRINCIPAL DISPLAY PANEL

dermaharmony

1% Pyrithione Zinc SOAP

For Seborrheic Dermatitis & Dandruff

NET WT 4.0 OZ (113 G)

INGREDIENTS AND APPEARANCE

DERMAHARMONY 1% PYRITHIONE ZINC 
pyrithione zinc soap

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 71819-010
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
PYRITHIONE ZINC (UNII: R953O2RHZ5) (PYRITHIONE ZINC - UNII:R953O2RHZ5)	PYRITHIONE ZINC	1 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
SODIUM CHLORIDE (UNII: 451W47IQ8X)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
WATER (UNII: 059QF0KO0R)
SODIUM COCOATE (UNII: R1TQH25F4I)
GLYCERIN (UNII: PDC6A3C0OX)
OATMEAL (UNII: 8PI54V663Y)
SODIUM PALM KERNELATE (UNII: 6H91L1NXTW)
OLIVE OIL (UNII: 6UYK2W1W1E)
SODIUM PALMATE (UNII: S0A6004K3Z)
.ALPHA.-TOCOPHEROL ACETATE, D- (UNII: A7E6112E4N)
PENTASODIUM PENTETATE (UNII: 961TOZ5L7T)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 71819-010-04	113 g in 1 CELLO PACK; Type 0: Not a Combination Product	01/27/2021

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M032	01/27/2021

Labeler - D3 Development, Inc. (043195877)

Establishment
Name	Address	ID/FEI	Business Operations
Vanguard Soap, LLC.		831404954	manufacture(71819-010)