Selenium Sulfide
FDA Label NDC 65255-409

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Sonar Products, Inc for the product Selenium Sulfide (NDC 65255-409). 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, use, warnings, otc - ask doctor, otc - when using, otc - stop use, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Other

Drug Facts

Manufactured By:
Sonar Products, Inc.
609 Industrial Road
Carlstadt, NJ 07072

Active Ingredient

Selenium sulfide 1%

Purpose

Antidandruff

Use

for relief of flaking and itching due to dandruff and seborrheic dermatitis and to help prevent their recurrence.

Warnings

For external use only

Otc - Ask Doctor

Ask a doctor before use if you have

  • seborrheic dermatitis in areas other than the scalp

Otc - When Using

When using this product

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

Otc - Stop Use

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 right away.

Directions

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

Inactive Ingredients

water, ammonium lauryl sulfate, ammonium laureth sulfate, dihydrogenated tallow phthalic acid amide, sodium chloride, cocamide DEA, dimethicone, aloe barbadensis leaf juice, titanium dioxide, hydroxypropyl methylcellulose, sodium isostearyl lactylate, DMDM hydantoin, fragrance, citric acid, sodium citrate, FD&C blue no.1 (245-067)

Principal Display Panel - 325 Ml Bottle Label

NDC 65255-409-88

SONAR PRODUCTS, INC.

SELENIUM
SULFIDE
1% SHAMPOO

Moisturizing Dandruff
Shampoo

11 Fl. Oz. (325 mL)

Principal Display Panel (325 mL Bottle Label)

Principal Display Panel (325 mL Bottle Label)

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