DERMAHARMONY PYRITHIONE ZINC WITH SHEA BUTTER- 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.

----------

2% Pyrithione Zinc Bar with Shea Butter

Drug Facts

Active ingredient

Pyrithione zinc 2%

Purpose

Dandruff, Seborrheic dermatitis soap

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, shea butter, sodium cocoate*, sodium palm kernelate*, glycerin, water, cocoa butter, titanium dioxide, Avena Sativa (oat) kernel flour, tetrasodium glutamate diacetate, tocopheryl acetate (vitamin E), Rosmarinus officinalis (rosemary) leaf extract. *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

2% Pyrithione Zinc SOAP with Shea Butter

For Seborrheic Dermatitis & Dandruff

NET WT 3.7 OZ (105 G)

71819-017 PZ with Shea Butter

DERMAHARMONY PYRITHIONE ZINC  WITH SHEA BUTTER
pyrithione zinc soap
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71819-017
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
PYRITHIONE ZINC (UNII: R953O2RHZ5) (PYRITHIONE ZINC - UNII:R953O2RHZ5) PYRITHIONE ZINC2 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
SHEA BUTTER (UNII: K49155WL9Y)  
COCOA BUTTER (UNII: 512OYT1CRR)  
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)  
TETRASODIUM GLUTAMATE DIACETATE (UNII: 5EHL50I4MY)  
SODIUM PALMATE (UNII: S0A6004K3Z)  
.ALPHA.-TOCOPHEROL ACETATE, D- (UNII: A7E6112E4N)  
ROSEMARY (UNII: IJ67X351P9)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:71819-017-37105 g in 1 PACKAGE; Type 0: Not a Combination Product04/25/2022
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart358H04/25/2022
Labeler - D3 Development, Inc. (043195877)

Revised: 4/2022
Document Id: dc7ba02c-bdbe-5136-e053-2995a90ac545
Set id: dc7ba02c-bdbd-5136-e053-2995a90ac545
Version: 1
Effective Time: 20220412
 
D3 Development, Inc.