DERMAHARMONY BAR PEPPERMINT- salicylic acid, sulfur 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

Salicylic Acid 2%

Sulfur 5%

PURPOSE

Purpose

Dandruff / sebhorreic dermatitis / psoriasis shampoo

INDICATIONS & USAGE

Uses

​Helps stop the symptoms of dandruff, sebhorreic dermatitis, and psoriasis.

WARNINGS

Warnings

For external use only

ASK DOCTOR

Ask a doctor before use if you havea 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 ifcondition 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 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, peppermint (Mentha Piperita) oil, coco glucoside, water, sodium methyl 2 sulfolaurate & disodium-2-sulfolaurate, cetearyl alcohol & ceteareth-20, tetrasodium glutamate diacetate, argan oil, oat (Avena Sativa) flour, sucrose cocoate, sodium isostearoyl lactylate

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: 71819-009-04

PRINCIPAL DISPLAY PANEL

dermaharmony

PEPPERMINT

Shampoo Barwith Sulfur & Salicylic Acid

FOR DANDRUFF, SEBORRHEIC DERMATITIS & PSORIASIS

NET WT 4 OZ (113 G)

INGREDIENTS AND APPEARANCE

DERMAHARMONY BAR  PEPPERMINT
salicylic acid, sulfur shampoo

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 71819-009
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SULFUR (UNII: 70FD1KFU70) (SULFUR - UNII:70FD1KFU70)	SULFUR	5 g  in 100 g
SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ)	SALICYLIC ACID	2 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
WATER (UNII: 059QF0KO0R)
ARGAN OIL (UNII: 4V59G5UW9X)
SODIUM ISETHIONATE (UNII: 3R36J71C17)
POLYOXYL 20 CETOSTEARYL ETHER (UNII: YRC528SWUY)
COCONUT ACID (UNII: 40U37V505D)
PEPPERMINT OIL (UNII: AV092KU4JH)
COCO GLUCOSIDE (UNII: ICS790225B)
SODIUM METHYL 2-SULFOLAURATE (UNII: I39GGJ23HV)
DISODIUM 2-SULFOLAURATE (UNII: 329M3829G2)
TETRASODIUM GLUTAMATE DIACETATE (UNII: 5EHL50I4MY)
OATMEAL (UNII: 8PI54V663Y)
SODIUM ISOSTEAROYL LACTYLATE (UNII: 8730J0D3EV)
SUCROSE COCOATE (UNII: 3H18P0UK73)
STEARIC ACID (UNII: 4ELV7Z65AP)
SODIUM COCOYL ISETHIONATE (UNII: 518XTE8493)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 71819-009-04	113 g in 1 CARTON; Type 0: Not a Combination Product	10/26/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M032	10/26/2020

Labeler - D3 Development, Inc. (043195877)

Establishment
Name	Address	ID/FEI	Business Operations
Vanguard Soap, LLC.		831404954	manufacture(71819-009)