Leader™

Leader™
SPL v4
SPL
SPL Set ID 7757ca84-8282-4465-a467-cd3f127d1286
Route
TOPICAL
Published
Effective Date 2024-02-29
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Pyrithione Zinc (10 mg)
Inactive Ingredients
Water Sodium Laureth-3 Sulfate Coco Monoethanolamide Sodium Lauryl Sulfate Glycol Distearate Dimethicone Cetyl Alcohol Guar Hydroxypropyltrimonium Chloride (1.7 Substituents Per Saccharide) Magnesium Sulfate, Unspecified Form Sodium Benzoate Magnesium Carbonate Hydroxide Ammonium Laureth-5 Sulfate Benzyl Alcohol Sodium Chloride Methylchloroisothiazolinone Methylisothiazolinone Sodium Xylenesulfonate Citric Acid Monohydrate Fd&c Blue No. 1 Fd&c Red No. 4

Identifiers & Packaging

Pill Appearance
Color: blue
Marketing Status
OTC MONOGRAPH DRUG Active Since 2019-10-10

Description

Drug Facts

Purpose

Anti-dandruff


Medication Information

Purpose

Anti-dandruff

Description

Drug Facts

Use

helps prevent recurrence of flaking and itching associated with dandruff

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.

Warnings

For external use only

Directions
  • shake well
  • wet hair
  • massage onto scalp
  • rinse
  • repeat if desired
  • for best results use at least twice a week or as directed by a doctor
  • for maximum dandruff control, use every time you shampoo
Active Ingredient

Pyrithione Zinc 1%

Other Information

store at room temperature

Inactive Ingredients

water, sodium laureth sulfate, cocamide MEA, sodium lauryl sulfate, glycol distearate, dimethicone, fragrance, cetyl alcohol, guar hydroxypropyltrimonium chloride, magnesium sulfate, sodium benzoate, magnesium carbonate hydroxide, ammonium laureth sulfate, benzyl alcohol, sodium chloride, methylchloroisothiazolinone, methylisothiazolinone, sodium xylenesulfonate, citric acid, blue 1, red 4.

Questions Or Comments?

1-866-567-8600

When Using This Product
  • do not get into 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 as directed
Principal Display Panel 420 Ml Bottle Label

LEADER

NDC 70000-0533-1

Dandruff

Shampoo

Pyrithione Zinc, 1%

Anti-Dandruff

Everyday

Clean

Basic Everyday

Cleaning for

Normal Hair

COMPARE TO

HEAD &

SHOULDERS®

active ingredient*

100% Money

Back Guarantee

14.2 FL OZ (420 mL)

05-3789


Structured Label Content

Use

helps prevent recurrence of flaking and itching associated with dandruff

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.

Purpose

Anti-dandruff

Warnings

For external use only

Directions
  • shake well
  • wet hair
  • massage onto scalp
  • rinse
  • repeat if desired
  • for best results use at least twice a week or as directed by a doctor
  • for maximum dandruff control, use every time you shampoo
Active Ingredient (Active ingredient)

Pyrithione Zinc 1%

Other Information (Other information)

store at room temperature

Inactive Ingredients (Inactive ingredients)

water, sodium laureth sulfate, cocamide MEA, sodium lauryl sulfate, glycol distearate, dimethicone, fragrance, cetyl alcohol, guar hydroxypropyltrimonium chloride, magnesium sulfate, sodium benzoate, magnesium carbonate hydroxide, ammonium laureth sulfate, benzyl alcohol, sodium chloride, methylchloroisothiazolinone, methylisothiazolinone, sodium xylenesulfonate, citric acid, blue 1, red 4.

Questions Or Comments? (Questions or comments?)

1-866-567-8600

When Using This Product (When using this product)
  • do not get into 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 as directed
Principal Display Panel 420 Ml Bottle Label (PRINCIPAL DISPLAY PANEL - 420 mL Bottle Label)

LEADER

NDC 70000-0533-1

Dandruff

Shampoo

Pyrithione Zinc, 1%

Anti-Dandruff

Everyday

Clean

Basic Everyday

Cleaning for

Normal Hair

COMPARE TO

HEAD &

SHOULDERS®

active ingredient*

100% Money

Back Guarantee

14.2 FL OZ (420 mL)

05-3789


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)