DERMAHARMONY TEA TREE BAR- pyrithione zinc shampoo

Dermaharmony Tea Tree Bar by

Drug Labeling and Warnings

Dermaharmony Tea Tree Bar by is a Otc medication manufactured, distributed, or labeled by D3 Development, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

ACTIVE INGREDIENT

Active ingredient

Pyrithione zinc 2%

PURPOSE

Purpose

Dandruff / seborrheic dermatitis shampoo

INDICATIONS & USAGE

Uses

Controls and reduces the symptoms of dandruff and seborrheic dermatitis.

WARNINGS

Warnings

For external use only

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

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

Stop use and ask a doctor ifcondition 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.

DOSAGE & ADMINISTRATION

Directions

• Use on affected areas in place of your regular shampoo
• For best results use at least twice a week or as directed by a doctor
• Rub between hands to create a lather, or apply bar directly onto hair
• Massage into the hair and scalp for 60-90 seconds, then rinse well

STORAGE AND HANDLING

Other information

• Store at room temperature

INACTIVE INGREDIENT

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

Questions?

1-800-827-3730

www.dermaharmony.com

SPL UNCLASSIFIED SECTION

Distributed by:

D3 Development, Inc., Portland, ME 04101

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

NDC Code: 71819-018-04

PRINCIPAL DISPLAY PANEL

dermaharmony

TEA TREE Shampoo Bar

with 2% Pyrithione Zinc

FOR DANDRUFF & SEBORRHEIC DERMATITIS

NET WT 4 OZ (113G)

INGREDIENTS AND APPEARANCE

DERMAHARMONY TEA TREE BAR 
pyrithione zinc shampoo

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 71819-018
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
PYRITHIONE ZINC (UNII: R953O2RHZ5) (PYRITHIONE ZINC - UNII:R953O2RHZ5)	PYRITHIONE ZINC	2 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 71819-018-04	113 g in 1 CARTON; Type 0: Not a Combination Product	09/29/2022

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M032	09/29/2022

Labeler - D3 Development, Inc. (043195877)

Establishment
Name	Address	ID/FEI	Business Operations
Vanguard Soap, LLC.		831404954	manufacture(71819-018)