FDA.reportPublic FDA data

FAMILY Wellness MAXIMUM STRENGTH DANDRUFF

Manufacturer
FAMILY DOLLAR SERVICES INC | Garcoa, Inc. | SV Labs Toronto Corporation
Effective date
2024-10-21
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-06-01 01:21:13

Label at a glance#

ProductFAMILY Wellness MAXIMUM STRENGTH DANDRUFF Anti-dandruff, anti-seborrheic dermatitis, anti-psoriasis
Active ingredientSELENIUM SULFIDE
Label structure11 sections

Indications and uses

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

Dosage and administration

shake well shampoo, then rinse thoroughly 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#

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Selenium sulfide 1%

Purpose

OTC - PURPOSE SECTION

Anti-Seborrheic Dermatitis, anti-dandruff

Uses

INDICATIONS & USAGE SECTION

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

Warnings

WARNINGS SECTION

SPL UNCLASSIFIED SECTION

For external use only.

Ask a doctor before use if

OTC - ASK DOCTOR SECTION

  • condition covers a large area of the body.

When using this product

OTC - WHEN USING SECTION

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

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 right away.

Directions

DOSAGE & ADMINISTRATION SECTION

  • shake well
  • shampoo, then rinse thoroughly
  • 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, ammonium laureth sulfate, ammonium lauryl sulfate, cocamide MEA, cocamidopropyl betaine, magnesium aluminum silicate, hydroxypropyl methylcellulose, fragrance, menthol, chlorphenesin, phenoxyethanol, citric acid, sodium chloride, blue 1, red 33.

Questions or comments?

OTC - QUESTIONS SECTION

1-866-567-8600

SPL UNCLASSIFIED SECTION

DISTRIBUTED BY: MIDWOOD BRANDS, LLC
500 VOLVO PKWY, CHESAPEAKE, VA 23320 USA

PRINCIPAL DISPLAY PANEL - 325 mL Bottle Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

FAMILY
Wellness™

COMPARE TO
THE ACTIVE
INGREDIENT IN
SELSUN BLUE®
MEDICATED
DANDRUFF
SHAMPOO*

MAXIMUM STRENGTH

DANDRUFF
SHAMPOO

SELENIUM SULFIDE 1%

  • For the relief of seborrheic
    dermatitis & dandruff symptoms
  • Helps control flaking & itching
  • For healthier-looking hair & scalp
  • Paraben free & Phthalate free

MEDICATED
+ MENTHOL

11 FL OZ (325 mL)

05-4742

Principal Display Panel - 325 mL Bottle Label
Principal Display Panel - 325 mL Bottle Label

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
204642selenium sulfide 1 % Medicated ShampooPSN4
204642selenium sulfide 10 MG/ML Medicated ShampooSCD4
204642selenium sulfide 1 % Lotion ShampooSY4
204642selenium sulfide 1 % Medicated ShampooSY4

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
55319-949-01FAMILY Wellness MAXIMUM STRENGTH DANDRUFFAnti-dandruff, anti-seborrheic dermatitis, anti-psoriasis325 mL in 1 BOTTLESHAMPOO3254

Products#

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

DailyMed product names page 1 of 1 · 16 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
55319-94955319-949-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 15 matching rows.

Name, UNII, Kind table
NameUNIIKind
SELENIUM SULFIDEZ69D9E381QACTIB
Water059QF0KO0RIACT
AMMONIUM LAURETH-5 SULFATE43ZIH89I48IACT
Ammonium Lauryl SulfateQ7AO2R1M0BIACT
COCO MONOETHANOLAMIDEC80684146DIACT
Cocamidopropyl Betaine5OCF3O11KXIACT
Magnesium Aluminum Silicate6M3P64V0NCIACT
HYPROMELLOSE, UNSPECIFIED3NXW29V3WOIACT
MENTHOL, UNSPECIFIED FORML7T10EIP3AIACT
ChlorphenesinI670DAL4SZIACT
PhenoxyethanolHIE492ZZ3TIACT
CITRIC ACID MONOHYDRATE2968PHW8QPIACT
Sodium Chloride451W47IQ8XIACT
FD&C BLUE NO. 1H3R47K3TBDIACT
D&C RED NO. 339DBA0SBB0LIACT

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
32024-10-21monthly-update2026-06-03 17:40:25

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
FAMILY Wellness MAXIMUM STRENGTH DANDRUFF Anti-dandruff, anti-seborrheic dermatitis, anti-psoriasisSELENIUM SULFIDEFAMILY DOLLAR SERVICES INC41a808e1-67a7-4b29-8ec4-d6c13cf622432024-10-21WarningsExact identifier
ndc (package): 55319-949-01
ndc (product): 55319-949
ndc11 (package): 55319094901
spl id: 97de0642-0cfc-4e29-838b-a0ff128fe95c
spl set id: 41a808e1-67a7-4b29-8ec4-d6c13cf62243

Reported adverse events (FAERS/openFDA)#

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