Leader™ - DailyMed Details

Leader™

SPL v5

SPL

SPL Set ID 509434a9-50c4-4337-8e5b-17bdc667d23b

Route

TOPICAL

Published

Effective Date 2024-03-13

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

Salicylic Acid (30 mg)

Inactive Ingredients

Water Sodium Laureth-3 Sulfate Cocamidopropyl Betaine Coco Monoethanolamide Sodium C14-16 Olefin Sulfonate Polyquaternium-7 (70/30 Acrylamide/dadmac; 1600000 Mw) Propylene Glycol Peg-150 Distearate Polyquaternium-10 (30000 Mpa.s At 2%) Sodium Citrate, Unspecified Form Sodium Hydroxide

Identifiers & Packaging

Pill Appearance

Color: yellow

Marketing Status

OTC MONOGRAPH DRUG Active Since 2022-08-30

Description

Drug Facts

Purpose

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

Medication Information

Purpose

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

Description

Drug Facts

Uses

control the symptoms of

dandruff
seborrheic dermatitis
psoriasis

Section 42229-5

Drug Facts

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 50569-3

Ask a doctor before use if you have a condition which 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 scalp
lather, leave on hair and scalp for several minutes
rinse and repeat.

Active Ingredient

Salicylic Acid 3.0%

Other Information

store at room temperature
store away from direct sunlight.

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

When Using This Product

avoid contact with the 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.

Principal Display Panel 133 Ml Bottle Label

LEADER_™

NDC 70000-0550-1

Therapeutic

Dandruff

Shampoo

Salicylic Acid, 3%

Anti-Dandruff

Anti-Seborrheic Dermatitis

Anti-Psoriasis

Controls the

Symptoms of Psoriasis,

Seborrheic Dermatitis

& Dandruff

Clears & Helps Prevent

Scalp Buildup

Fragrance-Free

Dye-Free

Preservative-Free

COMPARE TO

NEUTROGENA^® T/SAL^®

active ingredient*

100% Money Back Guarantee

4.5 FL OZ (133 mL)

05-3791B

Structured Label Content

Uses

control the symptoms of

dandruff
seborrheic dermatitis
psoriasis

Section 42229-5 (42229-5)

Drug Facts

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 50569-3 (50569-3)

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

Purpose

Anti-dandruff, anti-seborrheic dermatitis and 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 scalp
lather, leave on hair and scalp for several minutes
rinse and repeat.

Active Ingredient (Active ingredient)

Salicylic Acid 3.0%

Other Information (Other information)

store at room temperature
store away from direct sunlight.

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

When Using This Product (When using this product)

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

Stop Use and Ask A Doctor If (Stop use and ask a doctor if)

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

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

LEADER_™

NDC 70000-0550-1

Therapeutic

Dandruff

Shampoo

Salicylic Acid, 3%

Anti-Dandruff

Anti-Seborrheic Dermatitis

Anti-Psoriasis

Controls the

Symptoms of Psoriasis,

Seborrheic Dermatitis

& Dandruff

Clears & Helps Prevent

Scalp Buildup

Fragrance-Free

Dye-Free

Preservative-Free

COMPARE TO

NEUTROGENA^® T/SAL^®

active ingredient*

100% Money Back Guarantee

4.5 FL OZ (133 mL)

05-3791B

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 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": "Sodium C14-16 Olefin Sulfonate", "unii": "O9W3D3YF5U", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "POLYQUATERNIUM-7 (70/30 ACRYLAMIDE/DADMAC; 1600000 MW)", "unii": "0L414VCS5Y", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "Propylene Glycol", "unii": "6DC9Q167V3", "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": "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": "control the symptoms of dandruff seborrheic dermatitis psoriasis", "42229-5": "Drug Facts", "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.", "50569-3": "Ask a doctor before use if you have a condition which covers a large area of the body.", "Purpose": "Anti-dandruff, anti-seborrheic dermatitis and 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 scalp lather, leave on hair and scalp for several minutes rinse and repeat.", "Active ingredient": "Salicylic Acid 3.0%", "Other information": "store at room temperature store away from direct sunlight.", "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", "When using this product": "avoid contact with the 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.", "PRINCIPAL DISPLAY PANEL - 133 mL Bottle Label": "LEADER ™ NDC 70000-0550-1 Therapeutic Dandruff Shampoo Salicylic Acid, 3% Anti-Dandruff Anti-Seborrheic Dermatitis Anti-Psoriasis Controls the Symptoms of Psoriasis, Seborrheic Dermatitis & Dandruff Clears & Helps Prevent Scalp Buildup Fragrance-Free Dye-Free Preservative-Free COMPARE TO NEUTROGENA ® T/SAL ® active ingredient* 100% Money Back Guarantee 4.5 FL OZ (133 mL) 05-3791B"}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:07:17.923932 · Updated: 2026-03-14T23:10:33.744870