FDA.reportPublic FDA data

CeraVe Developed with Dermatologists Anti-Dandruff Hydrating

Manufacturer
L’Oreal USA Products Inc | L'OREAL USA, INC.
Effective date
2025-11-24
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 01:18:39

Label at a glance#

ProductCeraVe Developed with Dermatologists Anti-Dandruff Hydrating
Active ingredientPYRITHIONE ZINC
Label structure14 sections

Dosage and administration

for best results use at least twice a week or s directed by a doctor wet hair and massage onto scalp rinse and repeat if desired

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Pyrithione zinc 1%

Purpose

OTC - PURPOSE SECTION

Anti-dandruff

Use

INDICATIONS & USAGE SECTION

helps prevent recurrence of scalp flaking and itching associated with dandruff

Warnings

WARNINGS SECTION

For external use only

When using this product

OTC - WHEN USING SECTION

avoid contact with the 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 of this product as directed

Keep out of reach of children

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

Directions

DOSAGE & ADMINISTRATION SECTION

  • for best results use at least twice a week or s directed by a doctor
  • wet hair and massage onto scalp
  • rinse and repeat if desired

Inactive ingredients

INACTIVE INGREDIENT SECTION

water, sodium C14-16 olefin sulfonate, disodium laureth sulfosuccinate, disodium cocoamphodiacetate, sodium chloride, glycol distearate, amodimethicone, sodium lauryl sulfoacetate, PPG-5-ceteth-20, potato starch modified, cocamide MIPA, ceramide NP, ceramide AP, ceramide EOP, carbomer, niacinamide, trideceth-6, triethyl citrate, sodium hydroxide, sodium benzoate, sodium lauroyl lactylate, salicylic acid, sodium polynaphthalenesulfonate, sodium hyaluronate, cholesterol, phenoxyethanol coco-betaine, propylene glycol, citric acid, tetrasodium glutamate diacetate, cetrimonium chloride, caprylyl glycol, xanthan gum, phytosphingosine, polyquaternium-10, acrylates copolymer, benzoic acid

Questions or comments?

OTC - QUESTIONS SECTION

Toll-free number 1-888-768-2915

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

frontfrontfrontfrontfrontfront

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

backback

backbackbackbackbackback

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

562 mL front562 mL front

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

562 mL back562 mL back

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
209884zinc pyrithione 1 % Medicated ShampooPSN1
209884zinc pyrithione 10 MG/ML Medicated ShampooSCD1
209884zinc pyrithione 1 % Medicated ConditionerSY1
209884zinc pyrithione 1 % Medicated ShampooSY1

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
6bd95106-a412-1dad-b9cc-4cb74bfb27ceProduct name220230315
c6f86816-7da6-43ea-8c25-ac9758311cc5Product name120220118
f1e0dc7e-7d61-4625-b6d9-4894927679d7Product name220211025
e4870509-7e28-6f92-f0be-dd3dd889a9cfProduct name520200810
6e9d4a47-c464-b93e-aebc-ad7bffc9c4cdProduct name220190619
444b3e50-f226-46ef-bfca-2e7035d140cdProduct name120190611
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
dea2eded-d1e7-46bb-9a3d-f8dc20de6277Product name120190408
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
252e11b6-1a9a-4283-a242-df2c129c496dProduct name320170717
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
290f523a-f9db-9774-b5a9-e1f908ac1782Product name120150828
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
5668b646-cd56-c3c7-bdea-3f6b1a8840dbProduct name120140508
684ea482-2e8b-14af-5664-b98f1e402036Product name120140508
810ab97e-f109-f41c-7c83-6a652a9cbf43Product name120140508
87711080-88eb-65c5-b2dd-bf99e700a372Product name120140508
8dbefedf-0a0d-a224-5a3c-66dc9e11c2ddProduct name120140508
b060cc1a-fe47-856b-0b77-4448b5963de8Product name120140508
c6b65c52-69c7-df49-550a-a50c137f6218Product name120140508
ec2149b3-5c6d-5344-f757-c86411073075Product name120140508
ed912195-5da0-0f2f-6f4b-3ef17710cbe3Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
82046-228-01CeraVe Developed with Dermatologists Anti-Dandruff Hydrating562 mL in 1 BOTTLESHAMPOO5621
82046-228-02CeraVe Developed with Dermatologists Anti-Dandruff Hydrating355 mL in 1 BOTTLESHAMPOO3551

Products#

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

DailyMed product names page 1 of 1 · 37 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
82046-22882046-228-01, 82046-228-02

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 36 matching rows.

Name, UNII, Kind table
NameUNIIKind
PYRITHIONE ZINCR953O2RHZ5ACTIB
WATER059QF0KO0RIACT
SODIUM C14-16 OLEFIN SULFONATEO9W3D3YF5UIACT
DISODIUM LAURETH SULFOSUCCINATED6DH1DTN7EIACT
DISODIUM COCOAMPHODIACETATE18L9G3U51MIACT
SODIUM CHLORIDE451W47IQ8XIACT
GLYCOL DISTEARATE13W7MDN21WIACT
AMODIMETHICONE (1300 CST)3V7U636DWNIACT
SODIUM LAURYL SULFOACETATED0Y70F2B9JIACT
PPG-5-CETETH-204AAN25P8P4IACT
SODIUM HYDROLYZED POTATO STARCH DODECENYLSUCCINATEAPY6XCX4XAIACT
COCAMIDE MIPA21X4Y0VTB1IACT
CERAMIDE APF1X8L2B00JIACT
CERAMIDE NP4370DF050BIACT
CARBOMER0A5MM307FCIACT
NIACINAMIDE25X51I8RD4IACT
TRIDECETH-63T5PCR2H0CIACT
TRIETHYL CITRATE8Z96QXD6UMIACT
SODIUM HYDROXIDE55X04QC32IIACT
SODIUM BENZOATEOJ245FE5EUIACT
SODIUM LAUROYL LACTYLATE7243K85WFOIACT
SALICYLIC ACIDO414PZ4LPZIACT
SODIUM HYALURONATEYSE9PPT4THIACT
CHOLESTEROL97C5T2UQ7JIACT
PHENOXYETHANOLHIE492ZZ3TIACT
COCO-BETAINE03DH2IZ3FYIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
CITRIC ACID2968PHW8QPIACT
TETRASODIUM GLUTAMATE DIACETATE5EHL50I4MYIACT
CETRIMONIUM CHLORIDEUC9PE95IBPIACT
CAPRYLYL GLYCOL00YIU5438UIACT
XANTHAN GUMTTV12P4NEEIACT
PHYTOSPHINGOSINEGIN46U9Q2QIACT
POLYQUATERNIUM-10 (1000 MPA.S AT 2%)GMR4PEN8PKIACT
ACRYLAMIDOPROPYLTRIMONIUM CHLORIDE/ACRYLAMIDE COPOLYMER (400 MPA.S)2RX4MI2LCXIACT
BENZOIC ACID8SKN0B0MIMIACT

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
CeraVe Developed with Dermatologists Anti-Dandruff HydratingPYRITHIONE ZINCLOreal USA Products Inc0a64dfd9-13cc-4100-9c90-b006bac925052025-11-24WarningsExact identifier
ndc (package): 82046-228-01
ndc (package): 82046-228-02
ndc (product): 82046-228
ndc11 (package): 82046022801
ndc11 (package): 82046022802
spl id: 61c5a709-8ad8-4a89-883a-a011e8f0c57b
spl set id: 0a64dfd9-13cc-4100-9c90-b006bac92505

Reported adverse events (FAERS/openFDA)#

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