Leader Medicated Dandruff Shampoo
FDA Label NDC 70000-0531

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Cardinal Health, 110 Dba Leader for the product Leader Medicated Dandruff (NDC 70000-0531). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding other, active ingredient, purpose, uses, warnings, as a doctor before use if, when using this product, stop use and ask a doctor if, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

→ Other

→ Active Ingredient

→ Purpose

→ Uses

→ Warnings

→ As A Doctor Before Use If

→ When Using This Product

→ Stop Use And Ask A Doctor If

→ Otc - Keep Out Of Reach Of Children

→ Directions

→ Other Information

→ Inactive Ingredients

→ Questions Or Comments?

→ Principal Display Panel - 207 Ml Bottle Label

Other

Drug Facts

DIST BY CAH, DUBLIN, OH 43017

Active Ingredient

Selenium Sulfide 1%

Purpose

Anti-seborrheic dermatitis, anti-dandruff

Uses

for the relief of flaking and itching associated with dandruff and seborrheic dermatitis and to help prevent their recurrence.

Warnings

For external use only

As A Doctor Before Use If

♦condition covers a large area of the body.

When Using This Product

♦avoid contact with the eyes. If contact occurs, rinse eyes thoroughly with water.
♦for color-treated or permed hair, rinse thoroughly.

Stop Use And Ask A Doctor If

♦condition worsens or does not improve after regular use of this product as directed.

Otc - Keep Out Of Reach Of Children

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

Directions

♦shake well
♦shampoo, then rinse thoroughly
♦for best results, use at least twice a week or as directed by a doctor.

Other Information

store at room temperature

Inactive Ingredients

water, ammonium laureth sulfate, ammonium lauryl sulfate, cocamide MEA, cocamidopropyl betaine, magnesium aluminum silicate, hydroxypropyl methylcellulose, fragrance, menthol, chlorphenesin, phenoxyethanol, citric acid, sodium chloride, blue 1, red 33