DERMAHARMONY TEA TREE BAR- pyrithione zinc shampoo 
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 Tea Tree Shampoo Bar

Drug Facts

Active ingredient

Pyrithione zinc 2%

Purpose

Dandruff / seborrheic dermatitis shampoo

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 cocoyl isethionate (SCI), stearic acid, coconut fatty acid, sodium isethionate, tea tree (Melaleuca Alternifolia) leaf oil, water, soyethyl morpholinium ethosulfate, coco glucoside, cetearyl alcohol & ceteareth-20, benzyl alcohol, dehydroacetic acid, oat (Avena Sativa) flour, sodium methyl 2 sulfolaurate & disodium 2-sulfolaurate, argan oil, sucrose cocoate, sodium isostearoyl lactylate, iron oxides (ochre).

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: 71819-018-04

dermaharmony

TEA TREE Shampoo Bar

with 2% Pyrithione Zinc

FOR DANDRUFF & SEBORRHEIC DERMATITIS

NET WT 4 OZ (113G)

Dandruff Shampoo 71819-018-04

DERMAHARMONY TEA TREE BAR 
pyrithione zinc shampoo
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71819-018
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
OATMEAL (UNII: 8PI54V663Y)  
TEA TREE OIL (UNII: VIF565UC2G)  
DEHYDROACETIC ACID (UNII: 2KAG279R6R)  
ARGAN OIL (UNII: 4V59G5UW9X)  
DISODIUM 2-SULFOLAURATE (UNII: 329M3829G2)  
BENZYL ALCOHOL (UNII: LKG8494WBH)  
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)  
SODIUM METHYL 2-SULFOLAURATE (UNII: I39GGJ23HV)  
SODIUM ISETHIONATE (UNII: 3R36J71C17)  
SUCROSE COCOATE (UNII: 3H18P0UK73)  
POLYOXYL 20 CETOSTEARYL ETHER (UNII: YRC528SWUY)  
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:71819-018-04113 g in 1 CARTON; Type 0: Not a Combination Product09/29/2022
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalM03209/29/2022
Labeler - D3 Development, Inc. (043195877)

Revised: 9/2022
Document Id: e9d5eb14-1841-ae21-e053-2a95a90aa321
Set id: e9d5eb14-1840-ae21-e053-2a95a90aa321
Version: 1
Effective Time: 20220929
 
D3 Development, Inc.