Maximum Strength Therapeutic Dandruff Shampoo

SPL v1

SPL

SPL Set ID cd9caece-697f-4c74-956b-36687db0855c

Route

TOPICAL

Published

Effective Date 2024-03-07

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

Salicylic Acid (30 mg)

Inactive Ingredients

Water Sodium C14-16 Olefin Sulfonate Sodium Laureth-3 Sulfate Cocamidopropyl Betaine Coco Monoethanolamide Peg-150 Distearate Polyquaternium-10 (30000 Mpa.s At 2%) Propylene Glycol Sodium Citrate, Unspecified Form Sodium Hydroxide

Identifiers & Packaging

Pill Appearance

Color: yellow

Marketing Status

OTC MONOGRAPH DRUG Active Since 2023-06-05

Description

Drug Facts

Purpose

Anti-dandruff, anti-seborrheic dermatitis, anti-psoriasis

Medication Information

Purpose

Anti-dandruff, anti-seborrheic dermatitis, anti-psoriasis

Description

Drug Facts

Uses

controls the symptom of:

dandruff
seborrheic dermatitis
psoriasis

Section 42229-5

Drug Facts

Section 44425-7

Other information

store at room temperature
store away from direct sunlight

Section 50565-1

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

Section 50566-9

Stop use and ask a doctor if

⬥
condition worsens or does not improve after regular use of this product as directed.

Section 50567-7

When using this product

⬥
avoid contact with the eyes. If contact occurs, rinse eyes thoroughly with water.

Section 50569-3

Ask a doctor before use if you have a condition that covers a large area of the body.

Warnings

For external use only.

Directions

⬥
for best results use at least twice a week or as directed by a doctor.
⬥
wet hair thoroughly.
⬥
massage shampoo into the scalp.
⬥
lather, leave on hair and scalp for several minutes.
⬥
rinse and repeat.

Active Ingredient

Salicylic acid 3.0%

Inactive Ingredients

water, sodium C14-16 olefin sulfonate, sodium laureth sulfate, cocamidopropyl betaine, cocamide MEA, PEG-150 distearate, polyquaternium-10, propylene glycol, sodium citrate, sodium hydroxide

Questions Or Comments?

1-866-567-8600

Principal Display Panel 133 Ml Bottle Label

NDC 11822-2212-1

Compare to Neutrogena^®

T/Sal^® Therapeutic Shampoo

Scalp Build-Up Control*

FREE

FROM

PARABEN FREE

FRAGRANCE FREE

MAXIMUM STRENGTH

THERAPEUTIC

DANDRUFF

SHAMPOO

SALICYLIC ACID 3%

Controls dandruff,

psoriasis & seborrheic

dermatitis

Prevents flakes

& scalp buildup

4.5 FL OZ

(133 mL)

05-4294A

Structured Label Content

Uses

controls the symptom of:

dandruff
seborrheic dermatitis
psoriasis

Section 42229-5 (42229-5)

Drug Facts

Section 44425-7 (44425-7)

Other information

store at room temperature
store away from direct sunlight

Section 50565-1 (50565-1)

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

Section 50566-9 (50566-9)

Stop use and ask a doctor if

⬥
condition worsens or does not improve after regular use of this product as directed.

Section 50567-7 (50567-7)

When using this product

⬥
avoid contact with the eyes. If contact occurs, rinse eyes thoroughly with water.

Section 50569-3 (50569-3)

Ask a doctor before use if you have a condition that covers a large area of the body.

Purpose

Anti-dandruff, anti-seborrheic dermatitis, anti-psoriasis

Warnings

For external use only.

Directions

⬥
for best results use at least twice a week or as directed by a doctor.
⬥
wet hair thoroughly.
⬥
massage shampoo into the scalp.
⬥
lather, leave on hair and scalp for several minutes.
⬥
rinse and repeat.

Active Ingredient (Active ingredient)

Salicylic acid 3.0%

Inactive Ingredients (Inactive ingredients)

water, sodium C14-16 olefin sulfonate, sodium laureth sulfate, cocamidopropyl betaine, cocamide MEA, PEG-150 distearate, polyquaternium-10, propylene glycol, sodium citrate, sodium hydroxide

Questions Or Comments? (Questions or comments?)

1-866-567-8600

Principal Display Panel 133 Ml Bottle Label (PRINCIPAL DISPLAY PANEL - 133 mL Bottle Label)

NDC 11822-2212-1

Compare to Neutrogena^®

T/Sal^® Therapeutic Shampoo

Scalp Build-Up Control*

FREE

FROM

PARABEN FREE

FRAGRANCE FREE

MAXIMUM STRENGTH

THERAPEUTIC

DANDRUFF

SHAMPOO

SALICYLIC ACID 3%

Controls dandruff,

psoriasis & seborrheic

dermatitis

Prevents flakes

& scalp buildup

4.5 FL OZ

(133 mL)

05-4294A

Advanced Ingredient Data

[{"name": "Salicylic acid", "unii": "O414PZ4LPZ", "classCode": "ACTIB", "strengthNumerator": "30", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "mL"}, {"name": "Water", "unii": "059QF0KO0R", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "Sodium C14-16 Olefin Sulfonate", "unii": "O9W3D3YF5U", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "Sodium Laureth-3 Sulfate", "unii": "BPV390UAP0", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "Cocamidopropyl Betaine", "unii": "5OCF3O11KX", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "Coco Monoethanolamide", "unii": "C80684146D", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "PEG-150 Distearate", "unii": "6F36Q0I0AC", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "POLYQUATERNIUM-10 (30000 MPA.S AT 2%)", "unii": "C7RDC8Y4JS", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "Propylene Glycol", "unii": "6DC9Q167V3", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "Sodium Citrate, Unspecified Form", "unii": "1Q73Q2JULR", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "Sodium Hydroxide", "unii": "55X04QC32I", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}]

Raw Label Data

All Sections (JSON)

{"Uses": "controls the symptom of: dandruff seborrheic dermatitis psoriasis", "42229-5": "Drug Facts", "44425-7": "Other information store at room temperature store away from direct sunlight", "50565-1": "Keep out of reach of children . If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) right away.", "50566-9": "Stop use and ask a doctor if ⬥ condition worsens or does not improve after regular use of this product as directed.", "50567-7": "When using this product ⬥ avoid contact with the eyes. If contact occurs, rinse eyes thoroughly with water.", "50569-3": "Ask a doctor before use if you have a condition that covers a large area of the body.", "Purpose": "Anti-dandruff, anti-seborrheic dermatitis, anti-psoriasis", "Warnings": "For external use only.", "Directions": "⬥ for best results use at least twice a week or as directed by a doctor. ⬥ wet hair thoroughly. ⬥ massage shampoo into the scalp. ⬥ lather, leave on hair and scalp for several minutes. ⬥ rinse and repeat.", "Active ingredient": "Salicylic acid 3.0%", "Inactive ingredients": "water, sodium C14-16 olefin sulfonate, sodium laureth sulfate, cocamidopropyl betaine, cocamide MEA, PEG-150 distearate, polyquaternium-10, propylene glycol, sodium citrate, sodium hydroxide", "Questions or comments?": "1-866-567-8600", "PRINCIPAL DISPLAY PANEL - 133 mL Bottle Label": "NDC 11822-2212-1 Compare to Neutrogena ® T/Sal ® Therapeutic Shampoo Scalp Build-Up Control* FREE FROM PARABEN FREE FRAGRANCE FREE MAXIMUM STRENGTH THERAPEUTIC DANDRUFF SHAMPOO SALICYLIC ACID 3% Controls dandruff, psoriasis & seborrheic dermatitis Prevents flakes & scalp buildup 4.5 FL OZ (133 mL) 05-4294A"}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:02:50.918211 · Updated: 2026-03-14T23:02:37.591705