Xtracare Dandruff Hair Wash Shampoo
FDA Label NDC 57337-053

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Rejoice International for the product Xtracare Dandruff Hair Wash (NDC 57337-053). 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, otc - keep out of reach of children, indications & usage, warnings, dosage & administration, inactive ingredient, other safety information, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Otc - Active Ingredient

Active Ingredient                                Purpose

Salicylic Acid 3% ........................... Anti-dandruff

Otc - Purpose

Uses

for relief of flaking and itching due to dandruff and sebhorreic dermatitis, and to help prevent their recurrence

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.

Indications & Usage

*compare to active ingredients in Selsun Blue® naturals dandruff shampoo

XtraCare® Dandruff Shampoo Salicylic Acid 3%

Controls Flakes & Itch

  • Intensive Moisturizers
  • Enriched with Vitamin B5

    • 11 Fl Oz (325 mL)

Warnings

Warnings

For external use only

Ask a doctor before use if you have

  • sebhorreic dermatitis in areas other than the scalp

    • 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 of this product as directed.

Dosage & Administration

Directions

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

Inactive Ingredient

Inactive Ingredients: water, sodium laureth sulfate, sodium lauryl sulfate, cocamidopropyl betaine, cocamide MEA, fragrance, polyquaternium-10, disodium EDTA, citric acid, benzyl alcohol, panthenol (pro-vitamin B5), triclosan, fd&c blue no.1

Other Safety Information

Other Information store at room temperature

Questions/Comments? 1-855-345-5575

*This product is not manufactured or distributed by Chattem, Inc., owner of the registered trademark Selsun Blue® Naturals Dandruff Shampoo.

DISTRIBUTED BY:

REJOICE INTERNATIONAL INC

NORTHVILLE, MI 48168, USA

MADE IN CHINA

* Please review the disclaimer below.