Tarsum Professional
FDA Label NDC 11086-011

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Summers Laboratories Inc for the product Tarsum Professional (NDC 11086-011). 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 otc - active ingredient, otc - purpose, indications & usage, warnings, otc - ask doctor, otc - when using, otc - stop use, otc - keep out of reach of children, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Otc - Active Ingredient

CONTAINS

2% COAL TAR

(10% LCD EQUIV. TO 2% COAL TAR)

Otc - Purpose

PURPOSE

PSORIASIS, SEBORRHEIC DERMATITIS, DANDRUFF TREATMENT

Indications & Usage

USE

  • CONTROLS ITCHING, FLAKING AND REDNESS DUE TO PSORIASIS, SEBORRHEIC DERMATITIS AND DANDRUFF

Warnings

WARNINGS

FOR EXTERNAL USE ONLY

Otc - Ask Doctor

Ask a doctor before use if you have

  • condition that covers a large area of the body
  • condition in or around the rectum or genitals

Otc - When Using

When using this product

  • avoid contact with eyes. If contact occurs rinse eyes thoroughly with water.
  • use caution in exposing skin to sunlight after applying this product. It may increase your tendency to sunburn up to 24 hours after application.
  • do not use for prolonged periods without consulting a doctor.
  • do not use this product with other forms of psoriasis therapy such as ultraviolet radiation or prescription drugs unless directed to do so by a doctor.

Otc - Stop Use

Stop and ask a doctor if

  • condition worsens or does not improve after regular use as directed
  • excessive irritation occurs

Otc - Keep Out Of Reach Of Children

KEEP OUT OF REACH OF CHILDREN. IF SWALLOWED, GET MEDICAL HELP OR CONTCT A POISON CONTROL CENTER RIGHT AWAY.

Other Safety Information

Other information

In rare instances, temporary discoloration of gray or blonde hair may occur.

Store at controlled room temperature

59° to 86° F (15° to 30° C)

Dosage & Administration

Directions

  • For use as a scalp treatment before showering: Twist open applicator tip. Apply evenly to affected areas. Leave on for 5 minutes, gradually increasing treatment time to 1 hour, or as directed by your doctor. Rinse thoroughly.
  • As a shampoo: Wet hair, apply Tarsum for several minutes, then rinse.
  • For best results use twice a week or as directed by a physician.

Inactive Ingredient

Inactive ingredients

water, TEA lauryl sulfate, cocamide DEA, sodium lauryl sulfate, ethanol (8%), salicylic acid, triethanolamine, glycerin, lauryl alcohol, diethanolamine, sodium chloride, polysorbate 80, fragrance

Otc - Questions

Questions or comments?

Call 1-800-533-7546 (USA and Canada)

For more information go to www.sumlab.com

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