Assured Dandruff Shampoo

Assured Dandruff Shampoo
SPL v3
SPL
SPL Set ID 4688a1ed-9cd4-37a1-e054-00144ff8d46c
Route
TOPICAL
Published
Effective Date 2017-01-19
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Pyrithione Zinc (1 g)
Inactive Ingredients
Water Sodium Laureth Sulfate Cocamidopropyl Betaine Sodium Lauroamphoacetate Glycol Distearate Sodium Chloride Citric Acid Monohydrate Disodium Ethylenediaminediacetate Methylchloroisothiazolinone Methylisothiazolinone Fd&c Blue No. 1 Fd&c Yellow No. 5

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH FINAL Active Since 2017-01-19
Description

Drug Facts

Medication Information

Warnings and Precautions

Warnings

For external use only

Indications and Usage

Use

  • helps prevent recurrence of flaking and itching associated with dandruff.
Dosage and Administration

Directions

  • shake well.
  • wet hair.
  • massage into 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.
Description

Drug Facts

Section 42229-5

Drug Facts

Section 44425-7

Other information

  • store at 20°C (69° to 77°F)
Section 50565-1

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

Section 50566-9

Stop use and ask a doctor if

  • condition worsens or does not improve after regular use as directed.
Section 50567-7

When using this product

  • do not get into eyes. If contact occurs, rinse eyes thoroughly with water.
Section 51727-6

Inactive Ingredients

Water, Sodium Laureth Sulfate, Cocamidopropyl Betaine, Sodium Lauroamphoacetate, Glycol Distearate, Sodium Chloride, Fragrance, Citric Acid, Disodium EDTA, Methylchloroisothiazolinone, Methylisothiazolinone, Blue 1, Yellow 5.

Section 51945-4

ASSURED™

Dandruff Shampoo

Dry Scalp Care

MOISTURIZING

RELIEVES

DRYNESS • ITCHING • FLAKING

13.5 FL OZ (400 mL)

Section 55105-1

Purpose

Anti-dandruff

Section 55106-9

Active Ingredient

Zinc Pyrithione 1%

Structured Label Content

Indications and Usage (34067-9)

Use

  • helps prevent recurrence of flaking and itching associated with dandruff.
Dosage and Administration (34068-7)

Directions

  • shake well.
  • wet hair.
  • massage into 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.
Warnings and Precautions (34071-1)

Warnings

For external use only

Section 42229-5 (42229-5)

Drug Facts

Section 44425-7 (44425-7)

Other information

  • store at 20°C (69° to 77°F)
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 50566-9 (50566-9)

Stop use and ask a doctor if

  • condition worsens or does not improve after regular use as directed.
Section 50567-7 (50567-7)

When using this product

  • do not get into eyes. If contact occurs, rinse eyes thoroughly with water.
Section 51727-6 (51727-6)

Inactive Ingredients

Water, Sodium Laureth Sulfate, Cocamidopropyl Betaine, Sodium Lauroamphoacetate, Glycol Distearate, Sodium Chloride, Fragrance, Citric Acid, Disodium EDTA, Methylchloroisothiazolinone, Methylisothiazolinone, Blue 1, Yellow 5.

Section 51945-4 (51945-4)

ASSURED™

Dandruff Shampoo

Dry Scalp Care

MOISTURIZING

RELIEVES

DRYNESS • ITCHING • FLAKING

13.5 FL OZ (400 mL)

Section 55105-1 (55105-1)

Purpose

Anti-dandruff

Section 55106-9 (55106-9)

Active Ingredient

Zinc Pyrithione 1%

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T11:59:39.897155 · Updated: 2026-03-14T22:59:45.666904