FDA.reportPublic FDA data

DCL Zoma

Manufacturer
Milbar Laboratories | Milbar Labs, Inc
Effective date
2024-04-10
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 00:15:50

Label at a glance#

ProductDCL Zoma
Active ingredientPYRITHIONE ZINC
Label structure5 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Active ingredientActive ingredient

INACTIVE INGREDIENT SECTION

Inactive ingredientsInactive ingredients

OTC - PURPOSE SECTION

PurposePurpose

WARNINGS SECTION

WarningsWarnings

Warnings- Keep out of reach of children

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of childrenKeep out of reach of children

DOSAGE & ADMINISTRATION SECTION

Dosage and administrationDosage and administration

INDICATIONS & USAGE SECTION

indications and usageindications and usage

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Principal DisplayPrincipal Display

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
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
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
1681bc73-b05f-12c3-1075-382ae39f449cProduct name120140508
5668b646-cd56-c3c7-bdea-3f6b1a8840dbProduct name120140508
597b1cfd-7b31-5048-62be-ca5cd740da2fProduct 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
9869efd7-d6dd-0665-5b67-53adbe6ef15eProduct 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
57577-077-01DCL Zoma236 mL in 1 BOTTLE, DISPENSINGLOTION/SHAMPOO2361
57577-077-02DCL Zoma1 in 1 CARTONLOTION/SHAMPOO11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
57577-077DCL ZOMA (ZOMA SHAMPOO) LOTION/SHAMPOO [MILBAR LABORATORIES]12 package rows20240724_1def4cbc-74bd-8e71-e063-6294a90a4c0f.zip

Products#

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

DailyMed product names page 1 of 2 · 41 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
57577-07757577-077-01, 57577-077-02

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 39 matching rows.

Name, UNII, Kind table
NameUNIIKind
SERINE452VLY9402IACT
SODIUM LACTATETU7HW0W0QTIACT
PANTHENOLWV9CM0O67ZIACT
PIDOLIC ACIDSZB83O1W42IACT
SODIUM HYDROXIDE55X04QC32IIACT
WATER059QF0KO0RIACT
PHENYLALANINE47E5O17Y3RIACT
HYDROLYZED WHEAT PROTEIN (ENZYMATIC, 3000 MW)J2S07SB0YLIACT
PROLINE9DLQ4CIU6VIACT
METHYLISOTHIAZOLINONE229D0E1QFAIACT
GLYCERINPDC6A3C0OXIACT
EDETATE DISODIUM7FLD91C86KIACT
SODIUM BENZOATEOJ245FE5EUIACT
STARCH, WHEAT79QS2MG2LPIACT
SODIUM SULFATE0YPR65R21JIACT
HISTIDINE4QD397987EIACT
ARGININE94ZLA3W45FIACT
ASPARTIC ACID30KYC7MIAIIACT
DMDM HYDANTOINBYR0546TOWIACT
COCAMIDOPROPYL DIMETHYLAMINEL36BM7DG2TIACT
ISOLEUCINE04Y7590D77IACT
POTASSIUM SORBATE1VPU26JZZ4IACT
SODIUM C14-16 OLEFIN SULFONATEO9W3D3YF5UIACT
SODIUM CHLORIDE451W47IQ8XIACT
ALANINEOF5P57N2ZXIACT
VALINEHG18B9YRS7IACT
PYRITHIONE ZINCR953O2RHZ5ACTIB
FORMALDEHYDE/SODIUM NAPHTHALENESULFONATE COPOLYMER (3000 MW)90D834OZUIIACT
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIEDK679OBS311IACT
LAVENDER OILZBP1YXW0H8IACT
BENZYL ALCOHOLLKG8494WBHIACT
ACRYLATES/C10-30 ALKYL ACRYLATE CROSSPOLYMER (60000 MPA.S AT 0.5%)YY2HMJ9NZFIACT
GLYCINETE7660XO1CIACT
COCAMIDOPROPYL BETAINE5OCF3O11KXIACT
SODIUM DICHLOROACETATE42932X67B5IACT
THREONINE2ZD004190SIACT
TEA TREE OILVIF565UC2GIACT
SODIUM PYRROLIDONE CARBOXYLATE469OTG57A2IACT
METHYLCHLOROISOTHIAZOLINONEDEL7T5QRPNIACT

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
1def4cbc-74be-8e71-e063-6294a90a4c0f1def4cbc-74bd-8e71-e063-6294a90a4c0f2024-04-10WarningsExact identifier
spl id: 1def4cbc-74be-8e71-e063-6294a90a4c0f
spl set id: 1def4cbc-74bd-8e71-e063-6294a90a4c0f

Reported adverse events (FAERS/openFDA)#

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