FDA.reportPublic FDA data

First Aid Beauty FAB Ultra Repair Cream Skin Protectant Vanilla Cinnamon

Manufacturer
The Procter & Gamble Manufacturing Company
Effective date
2025-03-19
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 00:58:13

Label at a glance#

ProductFirst Aid Beauty FAB Ultra Repair Cream Intense Hydration Skin Protectant Fresh Strawberry
Active ingredientOATMEAL
Label structure10 sections

Indications and uses

Temporarily protects and helps relieve minor skin irritation and itching due to eczema, rashes, poison ivy, oak or sumac, insect bites

Dosage and administration

Apply as needed

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredients

OTC - ACTIVE INGREDIENT SECTION

Colloidal Oatmeal 0.5%

Purpose

OTC - PURPOSE SECTION

Skin Protectant

Uses

INDICATIONS & USAGE SECTION

  • Temporarily protects and helps relieve minor skin irritation and itching due to eczema, rashes, poison ivy, oak or sumac, insect bites

Warnings

WARNINGS SECTION

For external use only.

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.

OTC - WHEN USING SECTION

Do not get into eyes.

OTC - STOP USE SECTION

Stop use and ask a doctor if condition worsens, symptoms last more than 7 days or clear up and occur again within a few days

Directions

DOSAGE & ADMINISTRATION SECTION

Apply as needed

INACTIVE INGREDIENT SECTION

Water, stearic acid, glycerin, C12-15 alkyl benzoate, caprylic/capric triglyceride, glyceryl stearate, glyceryl stearate SE, cetearyl alcohol, butyrospermum parkii (shea) butter, dimethicone, squalane, phenoxyethanol, caprylyl glycol, isopropyl myristate, xanthan gum, butylene glycol, allantoin, sodium hydroxide, tetrasodium EDTA, ambroxide, ethyl 2-methylbutyrate, fragaria chiloensis (strawberry) fruit extract, ceramide NP, cis-3-hexenyl formate, methyl thiobutyrate, tocopherol

Questions:

OTC - QUESTIONS SECTION

888-FAB-3063

PRINCIPAL DISPLAY PANEL - 396.8 g (14 oz)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

First Aid Beauty

FAB

Ultra Repair® Cream

Intense Hydration

Skin Protectant Colloidal Oatmeal

FRESH STRAWBERRY

Net Wt. 396.8 g (14 oz)

FABFAB

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1654149colloidal oatmeal 0.5 % Topical CreamPSN1
1654149colloidal oatmeal 5 MG/ML Topical CreamSCD1
1654149colloidal oatmeal 0.5 % Topical CreamSY1

DailyMed Pharmacologic Classes#

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
84126-105-39First Aid Beauty FAB Ultra Repair Cream Intense Hydration Skin Protectant Fresh Strawberry396.8 g in 1 JARCREAM396.81

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
84126-105FIRST AID BEAUTY FAB ULTRA REPAIR CREAM INTENSE HYDRATION SKIN PROTECTANT FRESH STRAWBERRY (COLLOIDAL OATMEAL) CREAM [THE PROCTER & GAMBLE MANUFACTURING COMPANY]1Current NDC, 1 package rows20250402_30b2744d-fb59-f383-e063-6294a90abd2a.zip

Products#

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

DailyMed product names page 1 of 1 · 30 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
84126-10584126-105-39

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 28 matching rows.

Name, UNII, Kind table
NameUNIIKind
SQUALANEGW89575KF9IACT
BUTYLENE GLYCOL3XUS85K0RAIACT
3-HEXEN-1-OL, FORMATE, (Z)-E34OB83TYMIACT
GLYCERYL STEARATE SEFCZ5MH785IIACT
METHYL THIOBUTYRATE2P1E432MYZIACT
CETEARYL ALCOHOL2DMT128M1SIACT
DIMETHICONE92RU3N3Y1OIACT
TETRASODIUM EDTAMP1J8420LUIACT
C12-15 ALKYL BENZOATEA9EJ3J61HQIACT
CAPRYLYL GLYCOL00YIU5438UIACT
SODIUM HYDROXIDE55X04QC32IIACT
PHENOXYETHANOLHIE492ZZ3TIACT
BUTYROSPERMUM PARKII (SHEA) BUTTERK49155WL9YIACT
WATER059QF0KO0RIACT
GLYCERINPDC6A3C0OXIACT
OATMEAL8PI54V663YACTIB
ALLANTOIN344S277G0ZIACT
GLYCERYL STEARATE230OU9XXE4IACT
CAPRYLIC/CAPRIC TRIGLYCERIDEC9H2L21V7UIACT
STEARIC ACID4ELV7Z65APIACT
XANTHAN GUMTTV12P4NEEIACT
CERAMIDE NP4370DF050BIACT
BEACH STRAWBERRY98542F2TQSIACT
AMAROLIDER289636IZ6IACT
ETHYL 2-METHYLBUTYRATEL1T4AB29DSIACT
METHYL PHENYLACETATED4PDC41X96IACT
ISOPROPYL MYRISTATE0RE8K4LNJSIACT
TOCOPHEROLR0ZB2556P8IACT

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
First Aid Beauty FAB Ultra Repair Cream Intense Hydration Skin Protectant Fresh StrawberryCOLLOIDAL OATMEALThe Procter & Gamble Manufacturing Company30b2744d-fb59-f383-e063-6294a90abd2a2025-03-19WarningsExact identifier
ndc (package): 84126-105-39
ndc (product): 84126-105
ndc11 (package): 84126010539
spl id: 30b26684-7c93-f739-e063-6294a90a4f9e
spl set id: 30b2744d-fb59-f383-e063-6294a90abd2a

Reported adverse events (FAERS/openFDA)#

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