DERMAHARMONY 1% PYRITHIONE ZINC- pyrithione zinc soap 
D3 Development, Inc.

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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Pyrithione Zinc 1% Bar

Drug Facts

Active ingredient

Pyrithione zinc 1%

Purpose

Dandruff, Seborrheic dermatitis

Uses

Controls and reduces the symptoms of dandruff and seborrheic dermatitis.

Warnings

For external use only

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

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

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

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

Directions

Other information

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?

1-800-827-3730

www.dermaharmony.com

Distributed by:

D3 Development, Inc., Portland, ME 04101

Made in the USA

dermaharmony

1% Pyrithione Zinc SOAP

For Seborrheic Dermatitis & Dandruff

NET WT 4.0 OZ (113 G)

18197-4oz-Zinc-1Percent-Soap_V1D

DERMAHARMONY 1% PYRITHIONE ZINC 
pyrithione zinc soap
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71819-010
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
PYRITHIONE ZINC (UNII: R953O2RHZ5) (PYRITHIONE ZINC - UNII:R953O2RHZ5) PYRITHIONE ZINC1 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:71819-010-04113 g in 1 CELLO PACK; Type 0: Not a Combination Product01/27/2021
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart358H01/27/2021
Labeler - D3 Development, Inc. (043195877)

Revised: 1/2021
Document Id: b9e765eb-f560-f38a-e053-2a95a90aafd1
Set id: b9e765eb-f55f-f38a-e053-2a95a90aafd1
Version: 1
Effective Time: 20210127
 
D3 Development, Inc.