SPL v2
SPL
SPL Set ID dcd1275f-a6b9-466b-9340-2e8b56fdba82
Route
TOPICAL
Published
Effective Date 2014-02-05
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Salicylic Acid (10 g)
Inactive Ingredients
Water Sodium Laureth Sulfate Sodium Lauryl Sulfate Cocamidopropyl Betaine Coco Monoethanolamide Polyquaternium-10 (1000 Mpa.s At 2%) Edetate Disodium Citric Acid Monohydrate Benzyl Alcohol Panthenol Triclosan Fd&c Blue No. 1

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH FINAL Active Since 2014-02-05
Description

Active Ingredient                                Purpose Salicylic Acid 3% ........................... Anti-dandruff

Medication Information

Warnings and Precautions

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.
Indications and 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)

Dosage and Administration

Directions

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

Active Ingredient                                Purpose Salicylic Acid 3% ........................... Anti-dandruff

Section 50565-1

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Section 51727-6

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

Section 51945-4

Section 55105-1

Uses

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

Section 55106-9

Active Ingredient                                Purpose

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

Section 60561-8

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

Structured Label Content

Indications and Usage (34067-9)

*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)

Dosage and Administration (34068-7)

Directions

  • shampoo, then rinse thoroughly
  • for best results, use at least twice a week or as directed by a doctor
Warnings and Precautions (34071-1)

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.
Section 50565-1 (50565-1)

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Section 51727-6 (51727-6)

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

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

Uses

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

Section 55106-9 (55106-9)

Active Ingredient                                Purpose

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

Section 60561-8 (60561-8)

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

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T11:56:51.674048 · Updated: 2026-03-14T22:55:37.343071