FDA.reportPublic FDA data

Sulfur 8 Oil Moisturizer Anti-Dandruff Lotion

Manufacturer
J. Strickland & Co.
Effective date
2023-10-21
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 23:58:33

Label at a glance#

ProductSulfur 8 Oil Moisturizer Anti-Dandruff
Active ingredientPYRITHIONE ZINC
Label structure6 sections

Dosage and administration

Spray to apply to the affected area 1-4 times daily, or as directed by a doctor.

Label contents#

Full prescribing information#

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Pyrithione Zinc, 0.1%

Purpose

OTC - PURPOSE SECTION

Antidandruff

Use:

INDICATIONS & USAGE SECTION

Controls scalp itching and flaking due to dandruff

Warnings:

WARNINGS SECTION

For external use only

When using this product

OTC - WHEN USING SECTION

  • do not get into eyes. If contact occurs, rinse eyes thoroughly with water.

Stop use and consult a doctor if 

OTC - STOP USE SECTION

  • condition worsens or does not improve after regular use

Keep out of reach of children

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If swallowed, get medical help or call a poison control center at once.

Directions

DOSAGE & ADMINISTRATION SECTION

  • Spray to apply to the affected area 1-4 times daily, or as directed by a doctor.

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Water, Glycerin, PEG-12 Dimethicone, Propylene Glycol, Sodium Hydroxide, Hydrolyzed Collagen, Disodium EDTA, Diazolidinyl Urea, Fragrance, Methylparaben, Propylparaben.

Package Labeling

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

12022-019-0012022-019-00

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1052676pyrithione zinc 0.1 % Topical LotionPSN2
1052676zinc pyrithione 1 MG/ML Topical LotionSCD2
1052676zinc pyrithione 0.1 % Topical LotionSY2

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
12022-019-00Sulfur 8 Oil Moisturizer Anti-Dandruff237 mL in 1 BOTTLELOTION2372

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
12022-019SULFUR 8 OIL MOISTURIZER ANTI-DANDRUFF (PYRITHIONE ZINC) LOTION [J. STRICKLAND & CO.]2Current NDC, Legacy NDC, 1 package rows20231101_abb85f88-78bb-4d84-9436-4616b31c63d1.zip

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
12022-01912022-019-00

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
WATER059QF0KO0RIACT
MINERAL OILT5L8T28FGPIACT
ALOE VERA LEAFZY81Z83H0XIACT
ISOPROPYL MYRISTATE0RE8K4LNJSIACT
STEARYL ALCOHOL2KR89I4H1YIACT
POLYOXYL 20 CETOSTEARYL ETHERYRC528SWUYIACT
JOJOBA OIL724GKU717MIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0IACT
METHYLPARABENA2I8C7HI9TIACT
PROPYLPARABENZ8IX2SC1OHIACT
DIAZOLIDINYL UREAH5RIZ3MPW4IACT
SODIUM LAURYL SULFATE368GB5141JIACT
PANTHENOLWV9CM0O67ZIACT
PYRITHIONE ZINCR953O2RHZ5ACTIB

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
Sulfur 8 Oil Moisturizer Anti-DandruffPYRITHIONE ZINCJ. Strickland & Co.abb85f88-78bb-4d84-9436-4616b31c63d12023-10-21WarningsExact identifier
ndc (package): 12022-019-00
ndc (product): 12022-019
ndc11 (package): 12022001900
spl id: 08337902-0bf4-a579-e063-6294a90afc67
spl set id: abb85f88-78bb-4d84-9436-4616b31c63d1

Reported adverse events (FAERS/openFDA)#

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