FDA.reportPublic FDA data

First Aid Beauty FAB Ultra Repair Cream Skin Protectant Winter Mint

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 Skin Protectant Winter Mint
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 (2 oz)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

First Aid Beauty

FAB

Ultra Repair® Cream

Intense Hydration

Winter Mint

Skin Protectant Colloidal Oatmeal

Net Wt. 56.7 g (2 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

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-130810160800514GTIN-13: 0810160800514
EAN-13: 0810160800514
GTIN-12: 810160800514
UPC-A: 810160800514
GTIN storage (14 digits): 00810160800514		FAB.jpg

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
84126-044-56First Aid Beauty FAB Ultra Repair Skin Protectant Winter Mint56.7 g in 1 TUBECREAM56.72

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
84126-04484126-044-56

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
SPEARMINT OILC3M81465G5IACT
MENTHA ARVENSIS FLOWER OILQ129Z1W6Y2IACT
GLYCERYL STEARATE SEFCZ5MH785IIACT
PEPPERMINT OILAV092KU4JHIACT
CETEARYL ALCOHOL2DMT128M1SIACT
SQUALANEGW89575KF9IACT
DIMETHICONE92RU3N3Y1OIACT
TETRASODIUM EDTAMP1J8420LUIACT
C12-15 ALKYL BENZOATEA9EJ3J61HQIACT
CAMELLIA SINENSIS LEAFW2ZU1RY8B0IACT
CAPRYLYL GLYCOL00YIU5438UIACT
SODIUM HYDROXIDE55X04QC32IIACT
PHENOXYETHANOLHIE492ZZ3TIACT
BUTYROSPERMUM PARKII (SHEA) BUTTERK49155WL9YIACT
GLYCYRRHIZA GLABRA (LICORICE) ROOT2788Z9758HIACT
WATER059QF0KO0RIACT
GLYCERINPDC6A3C0OXIACT
OATMEAL8PI54V663YACTIB
ALLANTOIN344S277G0ZIACT
GLYCERYL STEARATE230OU9XXE4IACT
CAPRYLIC/CAPRIC TRIGLYCERIDEC9H2L21V7UIACT
STEARIC ACID4ELV7Z65APIACT
XANTHAN GUMTTV12P4NEEIACT
CERAMIDE NP4370DF050BIACT
TANACETUM PARTHENIUM WHOLE6GE7Z0761KIACT
EUCALYPTUS GLOBULUS LEAF OIL2R04ONI662IACT
MENTHA AQUATICA VAR. CITRATA LEAFZMA317E4J7IACT

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 Winter MintCOLLOIDAL OATMEALThe Procter & Gamble Manufacturing Company275ece2b-deb9-c95b-e063-6394a90aa9392025-12-18WarningsExact identifier
ndc (package): 84126-044-56
ndc (product): 84126-044
ndc11 (package): 84126004456
spl id: 46429cd9-bfee-523a-e063-6394a90a5080
spl set id: 275ece2b-deb9-c95b-e063-6394a90aa939

Reported adverse events (FAERS/openFDA)#

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