Topco Associates

Manufacturer
Topco Associates | Apollo Health and Beauty Care
Effective date
2023-05-04
Label type
HUMAN OTC DRUG LABEL
Version
5
Source
full-release
Hydrated at
2026-06-01 01:56:27

Label at a glance#

ProductTopco Associates
Active ingredientSELENIUM SULFIDE
Label structure9 sections

Storage and handling

store at room temperature.

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Selenium Sulfide 1%

OTC - PURPOSE SECTION

anti dandruff

WARNINGS SECTION

For external use only.

OTC - ASK DOCTOR SECTION

Ask a doctor before useif you have seborrheic dermatitis in areas other than the scalp.

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.

OTC - STOP USE SECTION

Stop use and ask a doctor ifcondition 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.In case of accidental ingestion, get medical help or contact a Poison Control Center immediately.

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.

STORAGE AND HANDLING SECTION

store at room temperature.

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).

OTC - QUESTIONS SECTION

1-888-423-0139

INDICATIONS & USAGE SECTION

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

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

11 oz11 oz

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
204642selenium sulfide 1 % Medicated ShampooPSN5
204642selenium sulfide 10 MG/ML Medicated ShampooSCD5
204642selenium sulfide 1 % Lotion ShampooSY5
204642selenium sulfide 1 % Medicated ShampooSY5

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-130036800000438GTIN-13: 0036800000438
EAN-13: 0036800000438
GTIN-12: 036800000438
UPC-A: 036800000438
GTIN storage (14 digits): 00036800000438
06847 06-25632-33 4TR Shampoo Medicated Dandruff 11oz.jpg

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
76162-171-11Topco Associates325 mL in 1 BOTTLE, PLASTICSHAMPOO3255

Products#

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

DailyMed product names page 1 of 1 · 18 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
76162-17176162-171-11

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 17 matching rows.

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
Topco AssociatesSELENIUM SULFIDETopco Associatesecf87660-f552-1f6b-e053-2a95a90a24862023-05-04WarningsExact identifier
ndc (package): 76162-171-11
ndc (product): 76162-171
ndc11 (package): 76162017111
spl id: 509ceebd-f4bc-f252-e063-6394a90abcd3
spl set id: ecf87660-f552-1f6b-e053-2a95a90a2486

Reported adverse events (FAERS/openFDA)#

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