DERMAHARMONY FACE AND BODY- pyrithione zinc soap

Dermaharmony Face and Body by

Drug Labeling and Warnings

Dermaharmony Face and Body 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

INDICATIONS & USAGE

Uses

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 soap / 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 body / hair
• Massage into the skin or 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, 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

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: 71819-008-04

PRINCIPAL DISPLAY PANEL

dermaharmony

Face & Body

with 2% Pyrithione Zinc

FOR DANDRUFF & SEBORRHEIC DERMATITIS

Reduces itching-irritation-redness-flaking-scaling

NET WT 4 OZ (113G)

INGREDIENTS AND APPEARANCE

DERMAHARMONY FACE AND BODY 
pyrithione zinc soap

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 71819-008
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
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 71819-008-04	113 g in 1 CARTON; Type 0: Not a Combination Product	03/15/2021

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M032	03/15/2021

Labeler - D3 Development, Inc. (043195877)

Establishment
Name	Address	ID/FEI	Business Operations
Vanguard Soap, LLC.		831404954	manufacture(71819-008)