FDA.reportPublic FDA data

Careone Medicated Dandruff

Manufacturer
Retail Business Services, LLC | Apollo Health and Beauty Care
Effective date
2021-08-26
Label type
HUMAN OTC DRUG LABEL
Version
5
Source
full-release
Hydrated at
2026-06-01 01:56:24

Label at a glance#

ProductCareone Medicated Dandruff
Active ingredientSELENIUM SULFIDE
Label structure9 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

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 Aluminium Silicate, Hydroxypropyl Methylcellulose, Methylchloroisothiazolinone, Methylisothiazolinone, Blue 1 (Cl 42090), Red 33 (Cl 17200).

Questions or comments ?

OTC - QUESTIONS SECTION

1-877-846-9949

PDP03

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

PDP03PDP03

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-130041520870636GTIN-13: 0041520870636
EAN-13: 0041520870636
GTIN-12: 041520870636
UPC-A: 041520870636
GTIN storage (14 digits): 00041520870636		PDP03.jpg

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
72476-025-03Careone Medicated Dandruff325 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
72476-02572476-025-03

Ingredients#

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

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

Name, UNII, Kind table
NameUNIIKind
METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (4500 MPA.S)T967IEU43CIACT
SODIUM LAURETH SULFATEBPV390UAP0IACT
CITRIC ACID MONOHYDRATE2968PHW8QPIACT
MENTHOLL7T10EIP3AIACT
SODIUM HYDROXIDE55X04QC32IIACT
HYPROMELLOSE, UNSPECIFIED3NXW29V3WOIACT
METHYLCHLOROISOTHIAZOLINONEDEL7T5QRPNIACT
METHYLISOTHIAZOLINONE229D0E1QFAIACT
FD&C BLUE NO. 1H3R47K3TBDIACT
D&C RED NO. 339DBA0SBB0LIACT
WATER059QF0KO0RIACT
TRIETHANOLAMINE LAURYL SULFATEE8458C1KAAIACT
COCAMIDOPROPYL BETAINE5OCF3O11KXIACT
FRAGRANCE CLEAN ORC0600327329LCV5BTFIACT
AMMONIUM CHLORIDE01Q9PC255DIACT
MAGNESIUM ALUMINUM SILICATE6M3P64V0NCIACT
SELENIUM SULFIDEZ69D9E381QACTIB

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
Careone Medicated DandruffSELENIUM SULFIDERetail Business Services, LLCcb05b9c6-c1bb-b210-e053-2a95a90afaea2021-08-26WarningsExact identifier
ndc (package): 72476-025-03
ndc (product): 72476-025
ndc11 (package): 72476002503
spl id: 50eb28f4-c45c-8101-e063-6294a90ac2f0
spl set id: cb05b9c6-c1bb-b210-e053-2a95a90afaea

Reported adverse events (FAERS/openFDA)#

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