FDA.reportPublic FDA data

MAXIMUM STRENGTH THERAPEUTIC DANDRUFF

Manufacturer
Rite Aid | Garcoa, INC | Sigan Industries INC
Effective date
2024-03-07
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 00:09:34

Label at a glance#

ProductMAXIMUM STRENGTH THERAPEUTIC DANDRUFF Anti-dandruff, anti-seborrheic dermatitis, anti-psoriasis
Active ingredientSalicylic acid
Label structure11 sections

Indications and uses

controls the symptom of: dandruff seborrheic dermatitis psoriasis

Dosage and administration

⬥ 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.

Storage and handling

Other information store at room temperature store away from direct sunlight

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Salicylic acid 3.0%

Purpose

OTC - PURPOSE SECTION

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

Uses

INDICATIONS & USAGE SECTION

controls the symptom of:

  • dandruff
  • seborrheic dermatitis
  • psoriasis

Warnings

WARNINGS SECTION

For external use only.

OTC - ASK DOCTOR SECTION

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

OTC - WHEN USING SECTION

When using this product

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

OTC - STOP USE SECTION

Stop use and ask a doctor if

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

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

Directions

DOSAGE & ADMINISTRATION SECTION

  • 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.

STORAGE AND HANDLING SECTION

Other information

  • store at room temperature
  • store away from direct sunlight

Inactive ingredients

INACTIVE INGREDIENT SECTION

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?

OTC - QUESTIONS SECTION

1-866-567-8600

SPL UNCLASSIFIED SECTION

DISTRIBUTED BY: RITE AID,
200 NEWBERRY COMMONS, ETTERS, PA 17319

PRINCIPAL DISPLAY PANEL - 133 mL Bottle Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

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

Principal Display Panel - 133 mL Bottle Label
Principal Display Panel - 133 mL Bottle Label

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
205023salicylic acid 3 % Medicated ShampooPSN1
205023salicylic acid 30 MG/ML Medicated ShampooSCD1
205023salicylic acid 3 % Medicated ShampooSY1

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
11822-2212-1MAXIMUM STRENGTH THERAPEUTIC DANDRUFF Anti-dandruff, anti-seborrheic dermatitis, anti-psoriasis133 mL in 1 BOTTLESHAMPOO1331

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
11822-2212MAXIMUM STRENGTH THERAPEUTIC DANDRUFF ANTI-DANDRUFF, ANTI-SEBORRHEIC DERMATITIS, ANTI-PSORIASIS (SALICYLIC ACID) SHAMPOO [RITE AID]11 package rows20240308_cd9caece-697f-4c74-956b-36687db0855c.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 12 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
11822-221211822-2212-1

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 11 matching rows.

Name, UNII, Kind table
NameUNIIKind
Salicylic acidO414PZ4LPZACTIB
Water059QF0KO0RIACT
Sodium C14-16 Olefin SulfonateO9W3D3YF5UIACT
Sodium Laureth-3 SulfateBPV390UAP0IACT
Cocamidopropyl Betaine5OCF3O11KXIACT
Coco MonoethanolamideC80684146DIACT
PEG-150 Distearate6F36Q0I0ACIACT
POLYQUATERNIUM-10 (30000 MPA.S AT 2%)C7RDC8Y4JSIACT
Propylene Glycol6DC9Q167V3IACT
Sodium Citrate, Unspecified Form1Q73Q2JULRIACT
Sodium Hydroxide55X04QC32IIACT

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
77ce3f24-626e-41c3-ace5-ac8f87e78dd2cd9caece-697f-4c74-956b-36687db0855c2024-03-07WarningsExact identifier
spl id: 77ce3f24-626e-41c3-ace5-ac8f87e78dd2
spl set id: cd9caece-697f-4c74-956b-36687db0855c

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.