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

Purpose

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

Description

Drug Facts

Medication Information

Warnings

For external use only

Uses

control the symptoms of

dandruff
seborrheic dermatitis
psoriasis

Purpose

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

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.

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.

Description

Drug Facts

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.

Active Ingredient

Salicylic Acid 3.0%

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

Warnings

For external use only

Uses

control the symptoms of

dandruff
seborrheic dermatitis
psoriasis

Purpose

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

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.

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.

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.

Active Ingredient (Active ingredient)

Salicylic Acid 3.0%

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