FDA.reportPublic FDA data

First Aid Beauty FAB Ultra Repair Cream Skin Protectant Vanilla

Manufacturer
The Procter & Gamble Manufacturing Company
Effective date
2025-12-09
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 01:21:16

Label at a glance#

ProductFirst Aid Beauty FAB Ultra Repair Intense Hydration Skin Protectant Warm Vanilla
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, dimethicone, butyrospermum parkii (shea) butter, squalene, phenoxyethanol, caprylyl glycol, xanthan gum, isobutyl methyl tetrahyropyranol, allantoin, sodium hydroxide, tetrasodium EDTA, ethyl hydroxypyrone, ceramide NP, anisaldehyde, etheyl 2-methyl butyrate, dipropylene glycol, tocopherol, 2-acetylpyrazine

Questions:

OTC - QUESTIONS SECTION

888-FAB-3063

PRINCIPAL DISPLAY PANEL - 14.0 oz (396.8 g)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

First Aid Beauty

FAB

Ultra Repair® Cream

Intense Hydration

Skin Protectant Colloidal Oatmeal

Warm Vanilla

FIrst Aid Beauty ®

Net Wt. 12.0 oz (340.2 g)

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

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-130810160801634GTIN-13: 0810160801634
EAN-13: 0810160801634
GTIN-12: 810160801634
UPC-A: 810160801634
GTIN storage (14 digits): 00810160801634		FAB.jpg

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
84126-213-34First Aid Beauty FAB Ultra Repair Intense Hydration Skin Protectant Warm Vanilla340.2 g in 1 JARCREAM340.21

Products#

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

DailyMed product names page 1 of 1 · 28 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
84126-21384126-213-34

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 26 matching rows.

Name, UNII, Kind table
NameUNIIKind
2-ACETYLPYRAZINEGR391IBU5CIACT
ETHYL HYDROXYPYRONEL6Q8K29L05IACT
DIPROPYLENE GLYCOLE107L85C40IACT
TOCOPHEROLR0ZB2556P8IACT
CETEARYL ALCOHOL2DMT128M1SIACT
SQUALANEGW89575KF9IACT
DIMETHICONE92RU3N3Y1OIACT
TETRASODIUM EDTAMP1J8420LUIACT
GLYCERYL STEARATE SEFCZ5MH785IIACT
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
ISOBUTYL METHYL TETRAHYDROPYRANOLVK5ZHH2T3FIACT
ETHYL 2-METHYLBUTYRATEL1T4AB29DSIACT
ANISALDEHYDE9PA5V6656VIACT

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 Intense Hydration Skin Protectant Warm VanillaCOLLOIDAL OATMEALThe Procter & Gamble Manufacturing Company45864832-51bb-4e24-e063-6294a90ab5542025-12-09WarningsExact identifier
ndc (package): 84126-213-34
ndc (product): 84126-213
ndc11 (package): 84126021334
spl id: 45864cd7-d95c-5d3b-e063-6294a90a1e1c
spl set id: 45864832-51bb-4e24-e063-6294a90ab554

Reported adverse events (FAERS/openFDA)#

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