Advanced Seborrheic Dermatitis Therapy

Advanced Seborrheic Dermatitis Therapy
SPL v1
SPL
SPL Set ID 354460ae-f367-3803-e054-00144ff88e88
Route
TOPICAL
Published
Effective Date 2016-06-10
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Pyrithione Zinc (2 g)
Inactive Ingredients
Water Sodium Palm Kernelate Sodium Palmate Palmitic Acid Glycerin Sodium Chloride Etidronate Tetrasodium Edetate Sodium Hydrogenated Jojoba Oil Titanium Dioxide Ferric Ferrocyanide Ferrous Oxide D&c Green No. 5 D&c Yellow No. 10

Identifiers & Packaging

Pill Appearance
Color: green
Marketing Status
OTC MONOGRAPH FINAL Active Since 2016-06-10

Description

Pyrithione Zinc 2%

Purpose

Dandruff/Seborrheic Dermatitis


Medication Information

Purpose

Dandruff/Seborrheic Dermatitis

Description

Pyrithione Zinc 2%

Use

For relief of skin itching, flaking, and scaling associated with dandruff and seborrheic dermatitis

Label

Section 50565-1
  • Keep out of the reach of children.
  • If swallowed, get medical help or contact a Poison Control Center immediately.
Section 51727-6

Sodium Palmate, Sodium Palm Kernelate, Water, Glycerin, Palmitic Acid, Titanium Dioxide (CI 77891), Sodium Chloride, Jojoba Esters, Tetrasodium EDTA, Tetrasodium Etidronate, Iron Oxides (CI 77499), Ferric Ferrocyanide, Green 5 (CI 61570),

Yellow 10 (CI 47005)

Warnings

For external use only

Directions

■ Use on affected areas in place of your regular soap

■ For best results use at least twice a week or as directed by a doctor

Questions?

www.CVS.com

1-800-SHOP CVS

Active Ingredient

Pyrithione Zinc 2%

Ask A Doctor Before Use

Ask a doctor before use if you have seborrheic dermatitis that covers a large portion of the body.

When Using This Product

■ avoid contact with the eyes. If contact occurs, rinse eyes thoroughly with water.

Stop Use and Ask A Doctor If

Stop use and ask a doctor if ■ condition worsens, or does not improve after regular use of this product as directed.


Structured Label Content

Use

For relief of skin itching, flaking, and scaling associated with dandruff and seborrheic dermatitis

Label

Section 50565-1 (50565-1)
  • Keep out of the reach of children.
  • If swallowed, get medical help or contact a Poison Control Center immediately.
Section 51727-6 (51727-6)

Sodium Palmate, Sodium Palm Kernelate, Water, Glycerin, Palmitic Acid, Titanium Dioxide (CI 77891), Sodium Chloride, Jojoba Esters, Tetrasodium EDTA, Tetrasodium Etidronate, Iron Oxides (CI 77499), Ferric Ferrocyanide, Green 5 (CI 61570),

Yellow 10 (CI 47005)

Purpose

Dandruff/Seborrheic Dermatitis

Warnings

For external use only

Directions

■ Use on affected areas in place of your regular soap

■ For best results use at least twice a week or as directed by a doctor

Questions?

www.CVS.com

1-800-SHOP CVS

Active Ingredient

Pyrithione Zinc 2%

Ask A Doctor Before Use (Ask a doctor before use)

Ask a doctor before use if you have seborrheic dermatitis that covers a large portion of the body.

When Using This Product (When using this product)

■ avoid contact with the eyes. If contact occurs, rinse eyes thoroughly with water.

Stop Use and Ask A Doctor If (Stop use and ask a doctor if)

Stop use and ask a doctor if ■ condition worsens, or does not improve after regular use of this product as directed.


Advanced Ingredient Data


Raw Label Data

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