Dermaharmony Face & Body Bar

Dermaharmony Face & Body Bar
SPL v2
SPL
SPL Set ID bd72b53c-b22c-40d0-e053-2995a90af9c1
Route
TOPICAL
Published
Effective Date 2021-03-15
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Pyrithione Zinc (2 g)
Inactive Ingredients
Steareth-20 Alpha-tocopherol Acetate Ferric Oxide Yellow Disodium 2-sulfolaurate Oatmeal Argan Oil Water Sodium Isostearoyl Lactylate Coco Glucoside Sodium Cocoyl Isethionate Stearic Acid Coconut Acid Soyethyl Morpholinium Ethosulfate Cetostearyl Alcohol Olive Oil Sodium Methyl 2-sulfolaurate Sodium Isethionate Sucrose Cocoate

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2021-03-15
Description

Drug Facts

Medication Information

Warnings and Precautions

Warnings

For external use only

Indications and Usage

Uses

Reduces the symptoms of dandruff and seborrheic dermatitis.

Dosage and 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
Description

Drug Facts

Section 42229-5

Drug Facts

Section 44425-7

Other information

  • Store at room temperature
Section 50565-1

Keep out of reach of children.If swallowed, get medical help or contact a Poison Control Center right away.

Section 50566-9

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

Section 50567-7

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

Section 50569-3

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

Section 51727-6

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).

Section 51945-4

dermaharmony

Face & Body

with 2% Pyrithione Zinc

FOR DANDRUFF & SEBORRHEIC DERMATITIS

Reduces itching-irritation-redness-flaking-scaling

NET WT 4 OZ (113G)

Section 53413-1

Questions?

1-800-827-3730

www.dermaharmony.com

Section 55105-1

Purpose

Dandruff / Seborrheic dermatitis

Section 55106-9

Active ingredient

Pyrithione zinc 2%

Structured Label Content

Indications and Usage (34067-9)

Uses

Reduces the symptoms of dandruff and seborrheic dermatitis.

Dosage and Administration (34068-7)

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
Warnings and Precautions (34071-1)

Warnings

For external use only

Section 42229-5 (42229-5)

Drug Facts

Section 44425-7 (44425-7)

Other information

  • Store at room temperature
Section 50565-1 (50565-1)

Keep out of reach of children.If swallowed, get medical help or contact a Poison Control Center right away.

Section 50566-9 (50566-9)

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

Section 50567-7 (50567-7)

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

Section 50569-3 (50569-3)

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

Section 51727-6 (51727-6)

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).

Section 51945-4 (51945-4)

dermaharmony

Face & Body

with 2% Pyrithione Zinc

FOR DANDRUFF & SEBORRHEIC DERMATITIS

Reduces itching-irritation-redness-flaking-scaling

NET WT 4 OZ (113G)

Section 53413-1 (53413-1)

Questions?

1-800-827-3730

www.dermaharmony.com

Section 55105-1 (55105-1)

Purpose

Dandruff / Seborrheic dermatitis

Section 55106-9 (55106-9)

Active ingredient

Pyrithione zinc 2%

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:04:59.239330 · Updated: 2026-03-14T23:06:13.532900