DERMAHARMONY BAR PEPPERMINT- pyrithione zinc shampoo

Dermaharmony Bar by

Drug Labeling and Warnings

Dermaharmony 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 DOCTOR

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

WHEN USING

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

STOP USE

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

KEEP OUT OF REACH OF CHILDREN

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 directly onto hair. Massage into the hair and scalp then rinse.

STORAGE AND HANDLING

Other information

• Store at room temperature

INACTIVE INGREDIENT

Inactive ingredients

Sodium cocoyl isethionate (SCI), stearic acid, coconut fatty acid, sodium isethionate, peppermint (Mentha Piperita) oil, 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, sodium isostearoyl lactylate, iron oxides (ochre).

QUESTIONS

Questions?

1-800-827-3730

www.dermaharmony.com

SPL UNCLASSIFIED SECTION

Distributed by:

D3 Development, Inc. (DBA DermaHarmony), Portland, ME 04101

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

NDC Code: 71819-005-45

PRINCIPAL DISPLAY PANEL

dermaharmony

PEPPERMINT

Shampoo Bar with 2% Pyrithione Zinc

FOR DANDRUFF & SEBORRHEIC DERMATITIS

NET WT 4.5 OZ (128 G)

INGREDIENTS AND APPEARANCE

DERMAHARMONY BAR  PEPPERMINT
pyrithione zinc shampoo

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 71819-005
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
BROWN IRON OXIDE (UNII: 1N032N7MFO)
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)
POLYOXYL 20 CETOSTEARYL ETHER (UNII: YRC528SWUY)
SOYETHYL MORPHOLINIUM ETHOSULFATE (UNII: J8C5W5HH18)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
PEPPERMINT OIL (UNII: AV092KU4JH)
SODIUM METHYL 2-SULFOLAURATE (UNII: I39GGJ23HV)
SODIUM ISETHIONATE (UNII: 3R36J71C17)
SUCROSE COCOATE (UNII: 3H18P0UK73)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 71819-005-45	128 g in 1 CARTON; Type 0: Not a Combination Product	03/24/2020
2	NDC: 71819-005-04	113 g in 1 CARTON; Type 0: Not a Combination Product	04/02/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part358H	03/24/2020

Labeler - D3 Development, Inc. (043195877)