DERMAHARMONY FACE AND BODY- 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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Dermaharmony Face & Body Bar

Drug Facts

Active ingredient

Pyrithione zinc 2%

Purpose

Dandruff / Seborrheic dermatitis

Uses

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 cocoyl isethionate (SCI), stearic acid, coconut fatty acid, sodium isethionate, coco glucoside, water, soyethyl morpholinium ethosulfate, cetearyl alcohol & ceteareth-20, sodium methyl 2 sulfolaurate & disodium 2-sulfolaurate, argan oil, oat (Avena Sativa) flour, sucrose cocoate, olive oil, tocopheryl acetate (vitamin E), sodium isostearoyl lactylate, iron oxides (yellow).

Questions?

1-800-827-3730

www.dermaharmony.com

Distributed by:

D3 Development, Inc., Portland, ME 04101

Made in USA of U.S. and imported ingredients.

NDC Code: 71819-008-04

dermaharmony

Face & Body

with 2% Pyrithione Zinc

FOR DANDRUFF & SEBORRHEIC DERMATITIS

Reduces itching-irritation-redness-flaking-scaling

NET WT 4 OZ (113G)

Face-Body-Bar-V3

DERMAHARMONY FACE AND BODY 
pyrithione zinc soap
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71819-008
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
STEARETH-20 (UNII: L0Q8IK9E08)  
ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
DISODIUM 2-SULFOLAURATE (UNII: 329M3829G2)  
OATMEAL (UNII: 8PI54V663Y)  
ARGAN OIL (UNII: 4V59G5UW9X)  
WATER (UNII: 059QF0KO0R)  
SODIUM ISOSTEAROYL LACTYLATE (UNII: 8730J0D3EV)  
COCO GLUCOSIDE (UNII: ICS790225B)  
SODIUM COCOYL ISETHIONATE (UNII: 518XTE8493)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
COCONUT ACID (UNII: 40U37V505D)  
SOYETHYL MORPHOLINIUM ETHOSULFATE (UNII: J8C5W5HH18)  
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
OLIVE OIL (UNII: 6UYK2W1W1E)  
SODIUM METHYL 2-SULFOLAURATE (UNII: I39GGJ23HV)  
SODIUM ISETHIONATE (UNII: 3R36J71C17)  
SUCROSE COCOATE (UNII: 3H18P0UK73)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:71819-008-04113 g in 1 CARTON; Type 0: Not a Combination Product03/15/2021
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart358H03/15/2021
Labeler - D3 Development, Inc. (043195877)

Revised: 3/2021
Document Id: bd72b53c-b22b-40d0-e053-2995a90af9c1
Set id: bd72b53c-b22c-40d0-e053-2995a90af9c1
Version: 1
Effective Time: 20210313
 
D3 Development, Inc.