Seborrheic Dermatitis Cream

Seborrheic Dermatitis Cream
SPL v3
SPL
SPL Set ID 8d81521d-9e6f-1acf-e053-2995a90a9242
Route
TOPICAL
Published
Effective Date 2019-07-26
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Pyrithione Zinc (0.25 g)
Inactive Ingredients
Phenoxyethanol Yellow Wax Glycerin Caprylyl Glycol Tocopherol Hydroxyethyl Cellulose (1800 Mpa.s At 2%) Stearyl Alcohol Almond Oil Water Avocado Oil Cetyl Alcohol Coconut Oil Castor Oil Behentrimonium Methosulfate Shea Butter Mangifera Indica Seed Butter

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2019-07-26

Description

Drug Facts


Medication Information

Warnings and Precautions

Warnings

For external use only

Indications and Usage

Uses

  • Relieves skin and/or scalp itching, irritation, redness, flaking and scaling due to seborrheic dermatitis
  • Helps eliminate recurrence of seborrheic dermatitis
Dosage and Administration

Directions

Apply to affected area one to four times daily

Description

Drug Facts

Section 42229-5

Drug Facts

Section 44425-7

Other information

  • Store at 59° to 77°F (15° to 25°C)
  • Lot number and expiration date can be found on lid.
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 of the product 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 ifcondition covers a large area of the body.

Section 51727-6

Inactive ingredients

Water, prunus amygdalus dulcis (sweet almond) oil, persea gratissima (avocado) oil, behentrimonium methosulfate, cetyl alcohol, glycerin, coco nucifera (coconut) oil, ricinus communis (castor) oil, stearyl alcohol, beeswax, shea butter, mango seed butter, phenoxyethanol, caprylyl glycol, tocopherol (vitamin E), hydroxyethylcellulose

Section 51945-4

dermaharmony

Seborrheic Dermatitis CREAM

Contains 0.25% Pyrithione Zinc

3 FL OZ (89 ml)

Section 53413-1

Questions?

1-800-827-3730

www.dermaharmony.com

Section 55105-1

Purpose

Seborrheic dermatitis cream

Section 55106-9

Active ingredient

Pyrithione zinc 0.25%


Structured Label Content

Indications and Usage (34067-9)

Uses

  • Relieves skin and/or scalp itching, irritation, redness, flaking and scaling due to seborrheic dermatitis
  • Helps eliminate recurrence of seborrheic dermatitis
Dosage and Administration (34068-7)

Directions

Apply to affected area one to four times daily

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 59° to 77°F (15° to 25°C)
  • Lot number and expiration date can be found on lid.
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 of the product 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 ifcondition covers a large area of the body.

Section 51727-6 (51727-6)

Inactive ingredients

Water, prunus amygdalus dulcis (sweet almond) oil, persea gratissima (avocado) oil, behentrimonium methosulfate, cetyl alcohol, glycerin, coco nucifera (coconut) oil, ricinus communis (castor) oil, stearyl alcohol, beeswax, shea butter, mango seed butter, phenoxyethanol, caprylyl glycol, tocopherol (vitamin E), hydroxyethylcellulose

Section 51945-4 (51945-4)

dermaharmony

Seborrheic Dermatitis CREAM

Contains 0.25% Pyrithione Zinc

3 FL OZ (89 ml)

Section 53413-1 (53413-1)

Questions?

1-800-827-3730

www.dermaharmony.com

Section 55105-1 (55105-1)

Purpose

Seborrheic dermatitis cream

Section 55106-9 (55106-9)

Active ingredient

Pyrithione zinc 0.25%


Advanced Ingredient Data


Raw Label Data

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