111medco Medicated Bar 2% Pyrithione Zinc

111medco Medicated Bar 2% Pyrithione Zinc
SPL v4
SPL
SPL Set ID 22e0c6f9-8884-4869-b13f-fc4976da58da
Route
TOPICAL
Published
Effective Date 2023-11-17
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Pyrithione Zinc (20 mg)
Inactive Ingredients
Sodium Palmate Sodium Cocoate Sodium Palm Kernelate Water Glycerin Sodium Chloride Pentasodium Pentetate

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2023-10-01

Description

Pyrithione Zine 2%

Purpose

Dandruff/Seborrheic Dermatitis


Medication Information

Purpose

Dandruff/Seborrheic Dermatitis

Description

Pyrithione Zine 2%

Uses
  • For relief of skin itching, flaking, and scaling associated with dandruff and 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 your healthcare provider
Drug Facts

Active Ingredient

Pyrithione Zine 2%

Package Labeling:

Inactive Ingredients

Sodium palmate, sodium cocoate*, sodium palm kernelate*, agua, glycerin, orange extract, sodium chloride, pentasodium pentetate. (*may contain this ingredient)

When Using This Product
  • skin irritation and dryness may occur if you use other topical acne medications at the same time or immediately following use of this product. If this occurs, use only one medication at a time unless directed by a healthcare provider.
Keep Out of Reach of Children.

If swallowed, get medial help or contact a Poison Control Center right away.


Structured Label Content

Uses
  • For relief of skin itching, flaking, and scaling associated with dandruff and seborrheic dermatitis
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 your healthcare provider
Drug Facts

Active Ingredient (Active ingredient)

Pyrithione Zine 2%

Package Labeling:

Inactive Ingredients (Inactive ingredients)

Sodium palmate, sodium cocoate*, sodium palm kernelate*, agua, glycerin, orange extract, sodium chloride, pentasodium pentetate. (*may contain this ingredient)

When Using This Product (When using this product)
  • skin irritation and dryness may occur if you use other topical acne medications at the same time or immediately following use of this product. If this occurs, use only one medication at a time unless directed by a healthcare provider.
Keep Out of Reach of Children. (Keep out of reach of children.)

If swallowed, get medial help or contact a Poison Control Center right away.


Advanced Ingredient Data


Raw Label Data

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