Medaclear
FDA Label NDC 51290-011

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Amico Educational Concepts, Inc. for the product Medaclear (NDC 51290-011). 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 active ingredient, purpose, use, ask a doctor before use, when using this product, stop use and ask a doctor if, keep out of reach of children, directions, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

→ Active Ingredient

→ Purpose

→ Use

→ Ask A Doctor Before Use

→ When Using This Product

→ Stop Use And Ask A Doctor If

→ Keep Out Of Reach Of Children

→ Directions

→ Other Information

→ Inactive Ingredients

→ Questions?

→ Principal Display Panel

→ Distributed By

Active Ingredient

Zinc Pyrithione 1.5%

Purpose

Antidandruff and Antisebborrheic Dermatitis

Use

helps prevent the symptoms from dandruff and/or Seborrheic Dermatitus such as itching, flaking, irritation and redness.

Ask A Doctor Before Use

if you have seborrheic dermatitis that covers a large area of the body.

On children under 2 years of age.

When Using This Product

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

Stop Use And Ask A Doctor If

condition worsens or does not improve after regular use.

Keep Out Of Reach Of Children

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

Directions

Wet hair, massage into scalp, rinse, repeat if desired. For maximum dandruff control, use every time you shampoo. For best results, use twice a week, or as directed by a doctor.