Zolidyne Shampoo
FDA Label NDC 51326-203

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Topiderm, Inc. for the product Zolidyne (NDC 51326-203). 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, otc - keep out of reach of children, directions, inactive ingredients, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Other

Drug Facts

Active Ingredient

Zinc Pyrithione, 2%

Purpose

Antidandruff, Seborrheic Dermatitis

Uses

  • A gentle, specially formulated shampoo for the control of flaking and itching associated with dandruff or seborrheic dermatitis.

Warnings

For external use only

  • Avoid contact with eyes. If contact occurs, rinse eyes thoroughly with water
  • If condition worsens or does not improve after regular use of this product as directed, consult a doctor
  • If condition covers a large area of the body, consult your doctor before using this product

Otc - Keep Out Of Reach Of Children

  • Keep out of reach of children. In case of accidental ingestion, seek professional assistance or contact a Poison Control Center immediately.

Directions

Massage into wet scalp, lather well and rinse, leaving lather on scalp for 3-5 minutes

  • For best results, use at least twice a week or as directed by your doctor.

Inactive Ingredients

Ammonium Lauryl Sulfate, Citric Acid, Cocamidopropyl Betaine, Ethylene Glycol Distearate, FD&C Blue #1, Fragrance, Glycerin, Hydroxypropyl Methylcellulose, Lauramide MIPA, Methylchloroisothiazolinone, Methylisothiazolinone, Sodium Laureth Sulfate, Water.

Principal Display Panel - 200 Ml Tube Label

DERMA
TOPIX

zolidyne
shampoo

Zinc Pyrithione, 2%

Net 6.7 fl. oz. (200 ml.)

Topix Pharmaceuticals, Inc.
N. Amityville, NY 11701

Principal Display Panel (200 ml Tube Label)

Principal Display Panel (200 ml Tube Label)

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