FDA.reportPublic FDA data

SIMPLY BODYCARE DANDRUFF

Manufacturer
New Pride Corp
Effective date
2023-04-01
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
legacy-cache
Hydrated at
2026-08-01 21:32:26

Label at a glance#

ProductSIMPLY BODYCARE DANDRUFF
Active ingredientPYRITHIONE ZINC
Label structure9 sections

Dosage and administration

• shake well • wet hair • massage shampoo into scalp • rinse • repeat if desired • for best results, use at least twice a week or as directed by a doctor • for maximum dandruff control, use every time you shampoo.

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Pyrithione zinc 0.5%

Purpose

OTC - PURPOSE SECTION

Anti-dandruff

Use

INDICATIONS & USAGE SECTION

helps prevent recurrence of flaking and itching associated with dandruff.

Warnings

WARNINGS SECTION

For external use only.

When using this product do not get into eyes. If contact occurs, rinse eyes thoroughly with water.

Stop use and ask a doctor if

OTC - STOP USE SECTION

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

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If swallowed, get medical help or contact a Posion Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

• shake well • wet hair • massage shampoo into scalp • rinse • repeat if desired • for best results, use at least twice a week or as directed by a doctor • for maximum dandruff control, use every time you shampoo.

Inactive ingredients

INACTIVE INGREDIENT SECTION

Water (Aqua), Sodium Laureth Sulfate, Cocamidopropyl Betaine, Sodium Lauryl Sulfate, Cocamide MEA, Styrene/Acrylates Copolymer, Guar Hydroxypropyltrimonium Chloride, Sodium Citrate, Fragrance, Sodium Chloride, Dimethicone, Methylisothiazolinone, Iodopropynyl Butylcarbamate, FD&C Blue No.1.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

labellabel

Products#

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

DailyMed product names page 1 of 1 · 13 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
58037-20558037-205-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 12 matching rows.

Name, UNII, Kind table
NameUNIIKind
SODIUM CITRATE1Q73Q2JULRIACT
SODIUM CHLORIDE451W47IQ8XIACT
METHYLISOTHIAZOLINONE229D0E1QFAIACT
DIMETHICONE92RU3N3Y1OIACT
IODOPROPYNYL BUTYLCARBAMATE603P14DHEBIACT
FD&C BLUE NO. 1H3R47K3TBDIACT
WATER059QF0KO0RIACT
SODIUM LAURETH SULFATEBPV390UAP0IACT
PYRITHIONE ZINCR953O2RHZ5ACTIB
COCAMIDOPROPYL BETAINE5OCF3O11KXIACT
SODIUM LAURYL SULFATE368GB5141JIACT
GUAR HYDROXYPROPYLTRIMONIUM CHLORIDE (1.7 SUBSTITUENTS PER SACCHARIDE)B16G315W7AIACT

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
fa0c55eb-cad4-42a5-e053-6394a90af4eafa0c5530-9540-7433-e053-6294a90ad9fa2023-04-01WarningsExact identifier
spl id: fa0c55eb-cad4-42a5-e053-6394a90af4ea
spl set id: fa0c5530-9540-7433-e053-6294a90ad9fa

Reported adverse events (FAERS/openFDA)#

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