Initial Drug Listing - Probliva Medicated Anti-fungal Shampoo

Initial Drug Listing - Probliva Medicated Anti-fungal Shampoo
SPL v1
SPL
SPL Set ID 46852aea-028c-71c2-e063-6394a90a8055
Route
TOPICAL
Published
Effective Date 2026-01-05
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Salicylic Acid (3 g) Zinc Pyrithione (1 g)
Inactive Ingredients
Water Tea Tree Oil Rosemary Oil Peppermint Oil

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2026-01-05
Description

Salicylic Acid 3% Zinc Pyrithione 1%

Medication Information

Warnings and Precautions

For external use only

Indications and Usage
  • shake well
  • shampoo, then rinse thoroughly
  • for best result, use at least twice a week or asdirected by a doctor
Dosage and Administration

For the relief of flaking, and itching associated withdandruff, and seborrheic denatitis and to help prevent their recurrence.

Description

Salicylic Acid 3% Zinc Pyrithione 1%

Section 50565-1

Keep out of reach of children.

Section 50566-9

condition worsens or does not improve after regularuse of this product as directed.

Section 50567-7
  • avoid contact with the eyes.lf contact occurs, rinseeyes thoroughly with water.
  • for color-treated or pemmed hair, rinse thoroughly.
Section 50569-3

condition covers a large area of the body

Section 51727-6

Water, Tea Tree Oil, Peppermint Oil, Rosemary Oil

Section 51945-4

Section 53413-1

Satisfaction guaranteed -For questions or comments,please [email protected]

Section 55105-1

Anti-Seborheic Dermatitisand psoriasis, Anti-Dandruff

Section 55106-9

Salicylic Acid 3%

Zinc Pyrithione 1%

Section 60561-8

Store at room temperature

Structured Label Content

Indications and Usage (34067-9)
  • shake well
  • shampoo, then rinse thoroughly
  • for best result, use at least twice a week or asdirected by a doctor
Dosage and Administration (34068-7)

For the relief of flaking, and itching associated withdandruff, and seborrheic denatitis and to help prevent their recurrence.

Warnings and Precautions (34071-1)

For external use only

Section 50565-1 (50565-1)

Keep out of reach of children.

Section 50566-9 (50566-9)

condition worsens or does not improve after regularuse of this product as directed.

Section 50567-7 (50567-7)
  • avoid contact with the eyes.lf contact occurs, rinseeyes thoroughly with water.
  • for color-treated or pemmed hair, rinse thoroughly.
Section 50569-3 (50569-3)

condition covers a large area of the body

Section 51727-6 (51727-6)

Water, Tea Tree Oil, Peppermint Oil, Rosemary Oil

Section 51945-4 (51945-4)

Section 53413-1 (53413-1)

Satisfaction guaranteed -For questions or comments,please [email protected]

Section 55105-1 (55105-1)

Anti-Seborheic Dermatitisand psoriasis, Anti-Dandruff

Section 55106-9 (55106-9)

Salicylic Acid 3%

Zinc Pyrithione 1%

Section 60561-8 (60561-8)

Store at room temperature

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:08:05.886517 · Updated: 2026-03-14T23:12:14.139281