FDA.reportPublic FDA data

First Aid Beauty FAB Ultra Repair Cream Skin Protectant

Manufacturer
The Procter & Gamble Manufacturing Company
Effective date
2023-01-01
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 00:56:40

Label at a glance#

ProductFirst Aid Beauty FAB Ultra Repair Skin Protectant Candy Cane
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, mentha arvensis (cornmint) oil, tetrasodium EDTA, mentha spicata (spearmint) leaf oil, chrysanthemum parthenium (feverfew) extract, eucalyptus globulus leaf oil, mentha piperita (peppermint) oil, camellia sinensis leaf extract, glycyrrhiza glabra (licorice) root extract, mentha citrata bergamot mint, ceramide NP,.

Questions:

OTC - QUESTIONS SECTION

888-FAB-3063

PRINCIPAL DISPLAY PANEL - 56.7 g tube

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

First Aid Beauty

FAB

Ultra Repair Cream

Intense Hydration

Skin Protectant Colloidal Oatmeal

FIrst Aid Beauty ®

Net Wt. 2.0 oz (56.7 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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
84126-100-56First Aid Beauty FAB Ultra Repair Skin Protectant Candy Cane56.7 g in 1 TUBECREAM56.71

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
84126-100FIRST AID BEAUTY FAB ULTRA REPAIR SKIN PROTECTANT CANDY CANE (COLLOIDAL OATMEAL) CREAM [THE PROCTER & GAMBLE MANUFACTURING COMPANY]1Current NDC, 1 package rows20250306_bec2f702-5ff5-ea66-e053-2a95a90ad1ec.zip

Products#

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

DailyMed product names page 1 of 1 · 29 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
84126-10084126-100-56

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 27 matching rows.

Name, UNII, Kind table
NameUNIIKind
CERAMIDE NP4370DF050BIACT
CETEARYL ALCOHOL2DMT128M1SIACT
EUCALYPTUS GLOBULUS LEAF OIL2R04ONI662IACT
SQUALANEGW89575KF9IACT
TETRASODIUM EDTAMP1J8420LUIACT
GLYCERYL STEARATE SEFCZ5MH785IIACT
C12-15 ALKYL BENZOATEA9EJ3J61HQIACT
CAMELLIA SINENSIS LEAFW2ZU1RY8B0IACT
CAPRYLYL GLYCOL00YIU5438UIACT
TANACETUM PARTHENIUM FLOWER7TVV9D7I89IACT
SODIUM HYDROXIDE55X04QC32IIACT
PHENOXYETHANOLHIE492ZZ3TIACT
BUTYROSPERMUM PARKII (SHEA) BUTTERK49155WL9YIACT
GLYCYRRHIZA GLABRA (LICORICE) ROOT2788Z9758HIACT
WATER059QF0KO0RIACT
GLYCERINPDC6A3C0OXIACT
OATMEAL8PI54V663YACTIB
ALLANTOIN344S277G0ZIACT
GLYCERYL STEARATE230OU9XXE4IACT
XANTHAN GUMTTV12P4NEEIACT
CAPRYLIC/CAPRIC TRIGLYCERIDEC9H2L21V7UIACT
STEARIC ACID4ELV7Z65APIACT
MENTHA AQUATICA VAR. CITRATA LEAFZMA317E4J7IACT
MENTHA PIPERITA (PEPPERMINT) OILAV092KU4JHIACT
MENTHA ARVENSIS LEAF OIL1AEY1M553NIACT
SPEARMINT OILC3M81465G5IACT
DIMETHICONE92RU3N3Y1OIACT

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 Skin Protectant Candy CaneCOLLOIDAL OATMEALThe Procter & Gamble Manufacturing Companybec2f702-5ff5-ea66-e053-2a95a90ad1ec2023-01-01WarningsExact identifier
ndc (package): 84126-100-56
ndc (product): 84126-100
ndc11 (package): 84126010056
spl id: bec2bf77-9dfc-56b7-e053-2995a90acdbf
spl set id: bec2f702-5ff5-ea66-e053-2a95a90ad1ec

Reported adverse events (FAERS/openFDA)#

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