2% Pyrithione Zinc Bar With Shea Butter

2% Pyrithione Zinc Bar With Shea Butter
SPL v2
SPL
SPL Set ID dc7ba02c-bdbd-5136-e053-2995a90ac545
Route
TOPICAL
Published
Effective Date 2022-04-12
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Pyrithione Zinc (2 g)
Inactive Ingredients
Shea Butter Cocoa Butter Sodium Chloride Titanium Dioxide Water Sodium Cocoate Glycerin Oatmeal Sodium Palm Kernelate Tetrasodium Glutamate Diacetate Sodium Palmate .alpha.-tocopherol Acetate, D- Rosemary

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2022-04-25

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 soap
  • For best results use at least twice a week or as directed by a doctor
  • Work up a lather using warm water and massage into affected areas
  • Rinse well
Description

Drug Facts

Section 42229-5

Drug Facts

Section 44425-7

Other information

  • Store at room temperature
  • Lot number and expiration date are printed on back panel.
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 palmate, shea butter, sodium cocoate*, sodium palm kernelate*, glycerin, water, cocoa butter, titanium dioxide, Avena Sativa (oat) kernel flour, tetrasodium glutamate diacetate, tocopheryl acetate (vitamin E), Rosmarinus officinalis (rosemary) leaf extract. *May contain this ingredient

Section 51945-4

dermaharmony

2% Pyrithione Zinc SOAP with Shea Butter

For Seborrheic Dermatitis & Dandruff

NET WT 3.7 OZ (105 G)

Section 53413-1

Questions?

1-800-827-3730

www.dermaharmony.com

Section 55105-1

Purpose

Dandruff, Seborrheic dermatitis soap

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 soap
  • For best results use at least twice a week or as directed by a doctor
  • Work up a lather using warm water and massage into affected areas
  • 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
  • Lot number and expiration date are printed on back panel.
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 palmate, shea butter, sodium cocoate*, sodium palm kernelate*, glycerin, water, cocoa butter, titanium dioxide, Avena Sativa (oat) kernel flour, tetrasodium glutamate diacetate, tocopheryl acetate (vitamin E), Rosmarinus officinalis (rosemary) leaf extract. *May contain this ingredient

Section 51945-4 (51945-4)

dermaharmony

2% Pyrithione Zinc SOAP with Shea Butter

For Seborrheic Dermatitis & Dandruff

NET WT 3.7 OZ (105 G)

Section 53413-1 (53413-1)

Questions?

1-800-827-3730

www.dermaharmony.com

Section 55105-1 (55105-1)

Purpose

Dandruff, Seborrheic dermatitis soap

Section 55106-9 (55106-9)

Active ingredient

Pyrithione zinc 2%


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)