FDA.reportPublic FDA data

First Aid Beauty FAB Ultra Repair Intense Hydration Skin Protectant

Manufacturer
The Procter & Gamble Manufacturing Company
Effective date
2025-12-09
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 01:21:14

Label at a glance#

ProductFirst Aid Beauty FAB Ultra Repair Intense Hydration Skin Protectant
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 SE, glyceryl stearate, cetearyl alcohol, dimethicone, squalane, butyrospermum parkii (shea) butter, phenoxyethanol, caprylyl glycol, xanthan gum, allantoin, sodium hydroxide, tetrasodium EDTA, chrysanthemum parthenium (feverfew) extract, camellia sinensis leaf extract, glycyrrhiza glabra (licorice) root extract, ceramide NP, eucalyptus globulus (eucalyptus) leaf oil

Questions:

OTC - QUESTIONS SECTION

888-FAB-3063

PRINCIPAL DISPLAY PANEL - 56.7 g (2 oz)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

First Aid Beauty

FAB

Ultra Repair Cream

Intense Hydration

Skin Protectant Colloidal Oatmeal

Net Wt. 226 g (8 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
84126-203-11First Aid Beauty FAB Ultra Repair Intense Hydration Skin Protectant113 g in 1 JARCREAM1132
84126-203-17First Aid Beauty FAB Ultra Repair Intense Hydration Skin Protectant170.1 g in 1 JARCREAM170.12
84126-203-22First Aid Beauty FAB Ultra Repair Intense Hydration Skin Protectant226 g in 1 TUBECREAM2262
84126-203-28First Aid Beauty FAB Ultra Repair Intense Hydration Skin Protectant28.3 g in 1 TUBECREAM28.32
84126-203-34First Aid Beauty FAB Ultra Repair Intense Hydration Skin Protectant340.2 g in 1 JARCREAM340.22
84126-203-56First Aid Beauty FAB Ultra Repair Intense Hydration Skin Protectant56.7 g in 1 TUBECREAM56.72

Products#

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

DailyMed product names page 1 of 1 · 25 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
84126-20384126-203-22, 84126-203-28, 84126-203-56, 84126-203-11, 84126-203-17, 84126-203-34

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 23 matching rows.

Name, UNII, Kind table
NameUNIIKind
CETEARYL ALCOHOL2DMT128M1SIACT
SQUALANEGW89575KF9IACT
DIMETHICONE92RU3N3Y1OIACT
TETRASODIUM EDTAMP1J8420LUIACT
GLYCERYL STEARATE SEFCZ5MH785IIACT
C12-15 ALKYL BENZOATEA9EJ3J61HQIACT
CAMELLIA SINENSIS LEAFW2ZU1RY8B0IACT
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
EUCALYPTUS GLOBULUS LEAF OIL2R04ONI662IACT
GLYCYRRHIZA GLABRA (LICORICE) ROOT POWDER2788Z9758HIACT

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 · 7 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
First Aid Beauty Face and Body Bestsellers KitCOLLOIDAL OATMEALThe Procter & Gamble Manufacturing Company5a974dbf-84ac-5374-e063-6294a90a8da02026-09-03WarningsExact identifier
ndc (package): 84126-203-11
ndc11 (package): 84126020311
First Aid Beauty Sensitive Skin Bestsellers KitCOLLOIDAL OATMEALJCS Global Distribution, Inc.57c3556a-aad3-3e65-e063-6394a90ab6892026-07-29WarningsExact identifier
ndc (package): 84126-203-56
ndc11 (package): 84126020356
First Aid Beauty Sensitive Skin Bestsellers KitCOLLOIDAL OATMEALThe Procter & Gamble Manufacturing Company535a0e8e-6bb4-6652-e063-6394a90aa7ff2026-06-03WarningsExact identifier
ndc (package): 84126-203-56
ndc11 (package): 84126020356
First Aid Beauty Sensitive Skin Bestsellers KitCOLLOIDAL OATMEALJCS Global Distribution, Inc.535e42a1-8b14-324d-e063-6394a90a3f652026-06-03WarningsExact identifier
ndc (package): 84126-203-56
ndc11 (package): 84126020356
First Aid Beauty Dry Skin Rescue KitCOLLOIDAL OATMEALThe Procter & Gamble Manufacturing Company4a93d029-d721-0bb5-e063-6294a90a17c42026-02-11WarningsExact identifier
ndc (package): 84126-203-56
ndc11 (package): 84126020356
First Aid Beauty Dry Skin Rescue Kit 5x Hydration PowerCOLLOIDAL OATMEALJCS Global Distribution, Inc.47d06283-21cd-4a69-e063-6294a90adb052026-01-07WarningsExact identifier
ndc (package): 84126-203-56
ndc11 (package): 84126020356
First Aid Beauty FAB Ultra Repair Intense Hydration Skin ProtectantCOLLOIDAL OATMEALThe Procter & Gamble Manufacturing Company446ddb19-4bdb-6827-e063-6394a90a6af82025-12-09WarningsExact identifier
ndc (package): 84126-203-17
ndc (package): 84126-203-56
ndc (package): 84126-203-11
ndc (package): 84126-203-22
ndc (package): 84126-203-28
ndc (package): 84126-203-34
ndc (product): 84126-203
ndc11 (package): 84126020322
ndc11 (package): 84126020311
ndc11 (package): 84126020356
ndc11 (package): 84126020317
ndc11 (package): 84126020328
ndc11 (package): 84126020334
spl id: 4586178f-147f-fd68-e063-6294a90a1aa2
spl set id: 446ddb19-4bdb-6827-e063-6394a90a6af8

Reported adverse events (FAERS/openFDA)#

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