FDA.reportPublic FDA data

Shopko Beauty Maximum Strength Medicated Dandruff

Manufacturer
Apollo Health and Beauty Care Inc.
Effective date
2018-02-16
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 22:54:35

Label at a glance#

ProductShopko Beauty Maximum Strength Medicated Dandruff
Active ingredientSELENIUM SULFIDE
Label structure8 sections

Indications and uses

for the relief of flaking and itching associated with dandruff and seborrheic dermatitis and to help prevent the chance of recurrence.

Dosage and administration

shake well, wet hair, massage onto scalp and rinse. for best results, use at least twice a week or as directed by a doctor.

Storage and handling

store at room temperature.

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Selenium Sulfide 1%

Purpose

OTC - PURPOSE SECTION

Anti-dandruff, Anti-seborrheic dermatitis

Uses

INDICATIONS & USAGE SECTION

for the relief of flaking and itching associated with dandruff and seborrheic dermatitis and to help prevent the chance of recurrence.

Warnings

WARNINGS SECTION

For external use only.

Ask a doctor before use if

OTC - ASK DOCTOR SECTION

you have seborrheic dermatitis in areas other than the scalp.

When using this product

OTC - WHEN USING SECTION

  • avoid contact with eyes. If contact occurs, rinse thoroughly with water.
  • for use on color-treated or permed hair, rinse thoroughly.
Stop use and ask a doctor if

OTC - STOP USE SECTION

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

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

In case of accidental ingestion, get medical help or contact a Poison Control Center immediately.

Directions

DOSAGE & ADMINISTRATION SECTION

  • shake well, wet hair, massage onto scalp and rinse.
  • for best results, use at least twice a week or as directed by a doctor.

Other information

STORAGE AND HANDLING SECTION

store at room temperature.

Inactive ingredients

INACTIVE INGREDIENT SECTION

Water (Aqua), Sodium Laureth Sulfate, TEA-Lauryl Sulfate, Cocamidopropyl Betaine, Acrylates Copolymer, Citric Acid, Fragrance (Parfum), Ammonium Chloride, Menthol, Sodium Hydroxide, Magnesium Aluminum Silicate, Hydroxypropyl Methylcellulose, Methylchloroisothiazolinone, Methylisothiazolinone, Blue 1 (CI 42090), Red 33 (CI 17200).

Questions or comments?

OTC - QUESTIONS SECTION

1-866-695-3030

Label Copy

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Image of the labelImage of the label

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
204642selenium sulfide 1 % Medicated ShampooPSN1
204642selenium sulfide 10 MG/ML Medicated ShampooSCD1
204642selenium sulfide 1 % Lotion ShampooSY1
204642selenium sulfide 1 % Medicated ShampooSY1

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-130010994000207GTIN-13: 0010994000207
EAN-13: 0010994000207
GTIN-12: 010994000207
UPC-A: 010994000207
GTIN storage (14 digits): 00010994000207		22596L.jpg

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
63148-005-112024-01-30C16284748780-11030e365-5282-111a-e063-dadaa90a10e2Drug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63148-005-11Shopko Beauty Maximum Strength Medicated Dandruff325 mL in 1 BOTTLE, PLASTICSHAMPOO3251

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63148-005SHOPKO BEAUTY MAXIMUM STRENGTH MEDICATED DANDRUFF (SELENIUM SULFIDE) SHAMPOO [APOLLO HEALTH AND BEAUTY CARE INC.]1Legacy NDC, 1 package rows20180216_11718386-df65-45a5-85c9-b9689d56f0b9.zip

Products#

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

DailyMed product names page 1 of 1 · 17 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
63148-00563148-005-11

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 16 matching rows.

Name, UNII, Kind table
NameUNIIKind
SELENIUM SULFIDEZ69D9E381QACTIB
WATER059QF0KO0RIACT
SODIUM LAURETH SULFATEBPV390UAP0IACT
TRIETHANOLAMINE LAURYL SULFATEE8458C1KAAIACT
COCAMIDOPROPYL BETAINE5OCF3O11KXIACT
METHACRYLIC ACID - METHYL METHACRYLATE COPOLYMER (1:1)74G4R6TH13IACT
CITRIC ACID MONOHYDRATE2968PHW8QPIACT
AMMONIUM CHLORIDE01Q9PC255DIACT
MENTHOLL7T10EIP3AIACT
SODIUM HYDROXIDE55X04QC32IIACT
MAGNESIUM ALUMINUM SILICATE6M3P64V0NCIACT
HYPROMELLOSES3NXW29V3WOIACT
METHYLCHLOROISOTHIAZOLINONEDEL7T5QRPNIACT
METHYLISOTHIAZOLINONE229D0E1QFAIACT
FD&C BLUE NO. 1H3R47K3TBDIACT
D&C RED NO. 339DBA0SBB0LIACT

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
ad2d71bf-b2fa-41e3-a3f5-659d8bc309f611718386-df65-45a5-85c9-b9689d56f0b92018-02-16WarningsExact identifier
spl id: ad2d71bf-b2fa-41e3-a3f5-659d8bc309f6
spl set id: 11718386-df65-45a5-85c9-b9689d56f0b9

Reported adverse events (FAERS/openFDA)#

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