FDA.reportPublic FDA data

ZO MEDICAL 3-STEP PEEL Kit

Manufacturer
ZO Skin Health, Inc. | G.S. COSMECEUTICAL USA, INC. | PakLab
Effective date
2018-04-03
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 22:55:11

Label at a glance#

ProductZO MEDICAL 3-STEP PEEL Kit
Active ingredientOATMEAL
Label structure9 sections

Indications and uses

Temporarily protects and helps relieve minor skin irritation and itching due to: rashes.

Dosage and administration

apply as needed

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Colloidal Oatmeal, 1%

Purpose

OTC - PURPOSE SECTION

Skin Protectant

Uses

INDICATIONS & USAGE SECTION

Temporarily protects and helps relieve minor skin irritation and itching due to:

  • rashes.

Warnings

WARNINGS SECTION

For external use only

OTC - WHEN USING SECTION

When using this product

  • do not get into eyes

Stop use and ask a doctor if

OTC - STOP USE SECTION

  • condition worsens
  • symptoms last more than 7 days or clear up and occur again within a few days

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of the reach of children

Directions

DOSAGE & ADMINISTRATION SECTION

apply as needed

Inactive ingredients

INACTIVE INGREDIENT SECTION

Water, Glycerin, Petrolatum, Distearyldimonium Chloride, Isopropyl Palmitate, Cyclopentasiloxane, Cetyl Alcohol, Butyrospermum Parkii (Shea) Butter, Benzyl Alcohol, Polymethyl Methacrylate, Dipotassium Glycyrrhizate, Benzalkonium Chloride, Butylene Glycol, Tocopheryl Acetate, Pentylene Glycol, 1,2-Hexanediol, Sodium Chloride, Alcohol, Isopropyl Alcohol, Beta-Glucan, Retinyl Palmitate, Ascorbic Acid, Dibenzyl Ether, Tetrapeptide-21, Myristoyl Pentapeptide-11.

SPL UNCLASSIFIED SECTION

DIST BY
ZO Skin Health, Inc.
Irvine, CA 92618

PRINCIPAL DISPLAY PANEL - Kit Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

ZO®MEDICAL

BY ZEIN OBAGI MD

NDC 42851-190-56

ZO® 3-STEP PEEL™
KIT

FOR PROFESSIONAL USE ONLY

6 treatments

Principal Display Panel - Kit Carton
Principal Display Panel - Kit Carton

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
240464colloidal oatmeal 1 % Topical LotionPSN2
240464colloidal oatmeal 10 MG/ML Topical LotionSCD2
240464colloidal oatmeal 1 % Topical LotionSY2

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
OATMEAL Pharmacologic Class Indexing2Indexing - Pharmacologic Class20181113

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
6c13b22c-b3ba-4127-b768-0132dd5ab0d1Product name120230829
c5cd4727-ac49-4409-82b1-5bd8006c3ec7Product name120171122
9869efd7-d6dd-0665-5b67-53adbe6ef15eProduct name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
42851-190-562021-07-23C16284748780-1c7ccaba7-125d-fd44-e053-dadaa90aa01bZO ® MEDICAL 3-STEP PEEL™ Kit

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
42851-083-56ZO MEDICAL 3-STEP PEEL Kit58 mL in 1 TUBELOTION348 mL10 mg in 1mL2
42851-190-56ZO MEDICAL 3-STEP PEEL Kit1 in 1 CARTONKIT12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
42851-083ZO MEDICAL 3-STEP PEEL KIT (OATMEAL) KIT [ZO SKIN HEALTH, INC.]2Legacy NDC20180411_4aba5644-615c-4d30-99b1-6f67b1d8c907.zip
42851-190ZO MEDICAL 3-STEP PEEL KIT (OATMEAL) KIT [ZO SKIN HEALTH, INC.]2Legacy NDC, 2 package rows20180411_4aba5644-615c-4d30-99b1-6f67b1d8c907.zip

Products#

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

DailyMed product names page 1 of 2 · 70 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
42851-19042851-190-56
42851-08342851-083-56

Ingredients#

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

DailyMed ingredient rows page 1 of 2 · 75 matching rows.

Name, UNII, Kind table
NameUNIIKind
Alcohol3K9958V90MINGR
Salicylic AcidO414PZ4LPZINGR
Trichloroacetic Acid5V2JDO056XINGR
Water059QF0KO0RINGR
LACTIC ACID, UNSPECIFIED FORM33X04XA5ATINGR
DIETHYLENE GLYCOL MONOETHYL ETHERA1A1I8X02BINGR
TERT-BUTYL ALCOHOLMD83SFE959INGR
Denatonium Benzoate4YK5Z54AT2INGR
FD&C YELLOW NO. 5I753WB2F1MINGR
Water059QF0KO0RINGR
MEDIUM-CHAIN TRIGLYCERIDESC9H2L21V7UINGR
Polysorbate 207T1F30V5YHINGR
RetinolG2SH0XKK91INGR
GlycerinPDC6A3C0OXINGR
ALLYL METHACRYLATEG2IG50653ZINGR
Stearyl Alcohol2KR89I4H1YINGR
Polysorbate 60CAL22UVI4MINGR
GLYCERYL MONOSTEARATE230OU9XXE4INGR
Butylene Glycol3XUS85K0RAINGR
CYCLOMETHICONE 50THT5PCI0RINGR
Palmitic Acid2V16EO95H1INGR
UBIDECARENONEEJ27X76M46INGR
TROLAMINE9O3K93S3TKINGR
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0INGR
Hydrogenated Jojoba Oil7F674YQ5SOINGR
GLYCYRRHIZINATE DIPOTASSIUMCA2Y0FE3FXINGR
Dimethicone92RU3N3Y1OINGR
CARBOXYPOLYMETHYLENE0A5MM307FCINGR
BUTYLATED HYDROXYTOLUENE1P9D0Z171KINGR
EDETATE DISODIUM ANHYDROUS8NLQ36F6MMINGR
Stearic Acid4ELV7Z65APINGR
LEVOMENOL24WE03BX2TINGR
Ascorbic AcidPQ6CK8PD0RINGR
Sorbitol506T60A25RINGR
PhenoxyethanolHIE492ZZ3TINGR
HEXAMETHYLCYCLOTRISILOXANEEPV75L8O0RINGR
CYCLOMETHICONE 4CZ227117JEINGR
CYCLOMETHICONE 6XHK3U310BAINGR
GREEN TEA LEAFW2ZU1RY8B0INGR
HYALURONATE SODIUMYSE9PPT4THINGR

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
cab51802-ca86-4679-9322-2fa6c83204074aba5644-615c-4d30-99b1-6f67b1d8c9072018-04-03WarningsExact identifier
spl id: cab51802-ca86-4679-9322-2fa6c8320407
spl set id: 4aba5644-615c-4d30-99b1-6f67b1d8c907

Reported adverse events (FAERS/openFDA)#

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