FDA.reportPublic FDA data

First Aid Beauty FAB Ultra Repair Cream Skin Protectant Vanilla Cinnamon

Manufacturer
The Procter & Gamble Manufacturing Company
Effective date
2025-12-18
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 01:29:59

Label at a glance#

ProductFirst Aid Beauty FAB Ultra Repair Intense Hydration Skin Protectant Vanilla Cinnamon
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, xanthan gum, allantoin, sodium hydroxide, tetrasodium EDTA, chrysanthemum parthenium (feverfew) extract, cocos nucifera (coconut) fruit extract, ricinus communis (castor) seed oil, vanillin, ethyl butyrate, ethyl hydroxypyrone, acetoin, phenethyl acetate, methyl 2-phenylacetate,dimethylhydroxy furanone, methylcyclopentenolone, delta decalactone

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

VANILLA CINNAMON

Net Wt. 396.8 g (14 oz)

FABFAB

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1654149colloidal oatmeal 0.5 % Topical CreamPSN2
1654149colloidal oatmeal 5 MG/ML Topical CreamSCD2
1654149colloidal oatmeal 0.5 % Topical CreamSY2

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
84126-048-01First Aid Beauty FAB Ultra Repair Intense Hydration Skin Protectant Vanilla Cinnamon2 in 1 PACKAGECREAM22
84126-048-01First Aid Beauty FAB Ultra Repair Intense Hydration Skin Protectant Vanilla Cinnamon396.8 g in 1 JARCREAM396.82
84126-048-39First Aid Beauty FAB Ultra Repair Intense Hydration Skin Protectant Vanilla Cinnamon396.8 g in 1 JARCREAM396.82

Products#

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

DailyMed product names page 1 of 1 · 33 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
84126-04884126-048-39, 84126-048-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 31 matching rows.

Name, UNII, Kind table
NameUNIIKind
VANILLINCHI530446XIACT
ETHYL BUTYRATEUFD2LZ005DIACT
ETHYL HYDROXYPYRONEL6Q8K29L05IACT
SQUALANEGW89575KF9IACT
ACETOINBG4D34CO2HIACT
RICINUS COMMUNIS (CASTOR) SEED OILD5340Y2I9GIACT
PHENETHYL ACETATE67733846OWIACT
DIMETHYLHYDROXY FURANONE20PI8YZP7AIACT
GLYCERYL STEARATE SEFCZ5MH785IIACT
METHYLCYCLOPENTENOLONE627E92X64BIACT
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
TANACETUM PARTHENIUM WHOLE6GE7Z0761KIACT
COCOS NUCIFERA (COCONUT) FRUIT3RT3536DHYIACT
DELTA-DECALACTONECNA0S5T234IACT
METHYL PHENYLACETATED4PDC41X96IACT

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 Vanilla CinnamonCOLLOIDAL OATMEALThe Procter & Gamble Manufacturing Company27722bd0-0a07-53ef-e063-6294a90ae9912025-12-18WarningsExact identifier
ndc (package): 84126-048-01
ndc (package): 84126-048-39
ndc (product): 84126-048
ndc11 (package): 84126004839
ndc11 (package): 84126004801
spl id: 4642b432-be3e-54ab-e063-6394a90adbd0
spl set id: 27722bd0-0a07-53ef-e063-6294a90ae991

Reported adverse events (FAERS/openFDA)#

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