Dermaharmony Tea Tree Shampoo Bar

Dermaharmony Tea Tree Shampoo Bar
SPL v2
SPL
SPL Set ID e9d5eb14-1840-ae21-e053-2a95a90aa321
Route
TOPICAL
Published
Effective Date 2022-09-29
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Pyrithione Zinc (2 g)
Inactive Ingredients
Oatmeal Tea Tree Oil Dehydroacetic Acid Argan Oil Disodium 2-sulfolaurate Benzyl Alcohol Water Sodium Isostearoyl Lactylate Coco Glucoside Sodium Cocoyl Isethionate Stearic Acid Coconut Acid Soyethyl Morpholinium Ethosulfate Cetostearyl Alcohol Sodium Methyl 2-sulfolaurate Sodium Isethionate Sucrose Cocoate Polyoxyl 20 Cetostearyl Ether Ferric Oxide Yellow

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2022-09-29

Description

Drug Facts


Medication Information

Warnings and Precautions

Warnings

For external use only

Indications and Usage

Uses

Controls and reduces the symptoms of dandruff and seborrheic dermatitis.

Dosage and 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
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, 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).

Section 51945-4

dermaharmony

TEA TREE Shampoo Bar

with 2% Pyrithione Zinc

FOR DANDRUFF & SEBORRHEIC DERMATITIS

NET WT 4 OZ (113G)

Section 53413-1

Questions?

1-800-827-3730

www.dermaharmony.com

Section 55105-1

Purpose

Dandruff / seborrheic dermatitis shampoo

Section 55106-9

Active ingredient

Pyrithione zinc 2%


Structured Label Content

Indications and Usage (34067-9)

Uses

Controls and reduces the symptoms of dandruff and seborrheic dermatitis.

Dosage and Administration (34068-7)

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
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, 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).

Section 51945-4 (51945-4)

dermaharmony

TEA TREE Shampoo Bar

with 2% Pyrithione Zinc

FOR DANDRUFF & SEBORRHEIC DERMATITIS

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 shampoo

Section 55106-9 (55106-9)

Active ingredient

Pyrithione zinc 2%


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)