FDA.reportPublic FDA data

Restoring Serum (73528-400)

Manufacturer
Zero Flakes Given, Inc.
Effective date
2026-04-16
Label type
HUMAN OTC DRUG LABEL
Version
9
Source
full-release
Hydrated at
2026-06-01 01:54:02

Label at a glance#

ProductTreatment
Active ingredientPYRITHIONE ZINC
Label structure8 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Zinc Pyrithione 0.125%

OTC - PURPOSE SECTION

Anti-Dandruff, Anti-seborrheic dermatitis

INDICATIONS & USAGE SECTION

For the relief of symptoms from scalp itch, irritation, flaking and redness associated with dandruff.

DOSAGE & ADMINISTRATION SECTION

  • Apply to affected areas 1-to-4 times daily or as directed by a doctor.
  • Apply liberally to damp or dry scalp, and gently massage with fingertips
  • Do not rinse off

WARNINGS SECTION

For external use only

OTC - WHEN USING SECTION

Avoid contact with eyes. If contact occurs rinse eyes thoroughly with water.

OTC - STOP USE SECTION

Stop use and ask a doctor if 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.

INACTIVE INGREDIENT SECTION

Aqua (Water, Eau), Aloe Barbadensis Leaf Juice, Propanediol, Glycerin, Carthamus Tinctorius (Safflower) Seed Oil, Mentha Citrata Oil, Salicylic Acid, Camellia Sinensis Leaf Extract, Epilobium Angustifolium Flower/Leaf/Stem Extract, Niacinamide, Panthenol, Lavandula Angustifolia (Lavender) Oil, Allium Sativum (Garlic) Bulb Extract, Yeast Ferment Extract, Cocos Nucifera (Coconut) Oil, Citrus Nobilis (Mandarin Orange) Peel Oil, Foeniculum Vulgare (Fennel) Oil, Vanillin, Cetearamidoethyldiethonium Succinoyl Hydrolyzed Pea Protein, Lactobacillus Ferment, Xanthan Gum, Sodium Polyacryloyldimethyl Taurate, Silica Caprylyl Silylate, Sodium Hydroxide, Sodium Polynaphthalenesulfonate, Raphanus Sativus (Radish) Root Extract, Propylene Glycol, Sodium Chloride, Citric Acid, Linalool

OTC - QUESTIONS SECTION

1-877-No-Flake (1-877-663-5253)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

v1v1

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
2275631zinc pyrithione 0.125 % Topical CreamPSN9
2275631zinc pyrithione 1.25 MG/ML Topical CreamSCD9
2275631zinc pyrithione 0.125 % Topical CreamSY9

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
0fbf7978-a66d-d22e-cf47-78546f9f9c42Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
73528-400-01Treatment100 mL in 1 TUBECREAM1009
73528-400-02Treatment30 mL in 1 TUBECREAM309
73528-400-03Treatment5 mL in 1 PACKETCREAM59
73528-400-04Treatment60 mL in 1 TUBECREAM609

Products#

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

DailyMed product names page 1 of 1 · 34 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
73528-40073528-400-03, 73528-400-02, 73528-400-01, 73528-400-04

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 32 matching rows.

Name, UNII, Kind table
NameUNIIKind
WATER059QF0KO0RIACT
PYRITHIONE ZINCR953O2RHZ5ACTIB
ALOE BARBADENSIS LEAF JUICERUE8E6T4NBIACT
EPILOBIUM ANGUSTIFOLIUM WHOLEC278QS9YBTIACT
COCOS NUCIFERA (COCONUT) OILQ9L0O73W7LIACT
FOENICULUM VULGARE (FENNEL) OIL59AAO5F6HTIACT
LIMOSILACTOBACILLUS FERMENTUM2C1F12C6APIACT
SODIUM HYDROXIDE55X04QC32IIACT
MENTHA CITRATA LEAFZMA317E4J7IACT
LAVANDULA ANGUSTIFOLIA (LAVENDER) OILZBP1YXW0H8IACT
SILICA, TRIMETHYLSILYL CAPPEDVU10KU4B9SIACT
CARTHAMUS TINCTORIUS (SAFFLOWER) SEED OIL65UEH262ISIACT
CITRUS NOBILIS (MANDARIN ORANGE) PEEL OILNJO720F72RIACT
PEA PROTEIN7Q50F46595IACT
SODIUM POLYACRYLOYLDIMETHYL TAURATENG5NG5733TIACT
NIACINAMIDE25X51I8RD4IACT
VANILLINCHI530446XIACT
PENTOSAN POLYSULFATE SODIUM914032762YIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
LINALOOL, (+/-)-D81QY6I88EIACT
CAMELLIA SINENSIS LEAFW2ZU1RY8B0IACT
YEAST, UNSPECIFIED3NY3SM6B8UIACT
GLYCERINPDC6A3C0OXIACT
PANTHENOLWV9CM0O67ZIACT
ALLIUM SATIVUM WHOLEIIF21WT8O3IACT
PROPANEDIOL5965N8W85TIACT
SALICYLIC ACIDO414PZ4LPZIACT
RAPHANUS SATIVUS86R5J6D01DIACT
SODIUM CHLORIDE451W47IQ8XIACT
CITRIC ACID2968PHW8QPIACT
SALVIA SCLAREA (CLARY) OIL87L0D4U3M0IACT
XANTHAN GUMTTV12P4NEEIACT

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
82025-02-05monthly-update2026-06-03 17:38:57
72025-01-26full-release2026-06-01 00:53:43

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
53eb6d9f-3bf8-e2f4-e063-6394a90aad7f984816e3-3096-44c6-e053-2995a90af1aa2026-06-10WarningsExact identifier
spl set id: 984816e3-3096-44c6-e053-2995a90af1aa

Reported adverse events (FAERS/openFDA)#

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