FDA.reportPublic FDA data

First Aid Beauty FAB Ultra Repair Cream Skin Protectant Cucumber Melon

Manufacturer
The Procter & Gamble Manufacturing Company
Effective date
2025-03-07
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 00:56:55

Label at a glance#

ProductFirst Aid Beauty FAB Ultra Repair Cream Intense Hydration Skin Protectant Cucumber Melon
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, prunus armeniaca (apricot) fruit extract, chrysanthemum parthenium (feverfew) extract, santalum album (sandalwood) wood extract, camellia sinensis leaf extract, glycyrrhiza glabra (licorice) root extract, ceramide NP, cucumis melo (melon) fruit extract, cucumis sativus (cucumber) fruit extract, pyrus malus (apple) fruit extract, rose extract, rubus idaeus (raspberry) fruit extract

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

CUCUMBER + MELON

Net Wt. 396.8 g (14 oz)

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
84126-102-39First Aid Beauty FAB Ultra Repair Cream Intense Hydration Skin Protectant Cucumber Melon396.8 g in 1 JARCREAM396.81

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
84126-102FIRST AID BEAUTY FAB ULTRA REPAIR CREAM INTENSE HYDRATION SKIN PROTECTANT CUCUMBER MELON (COLLOIDAL OATMEAL) CREAM [THE PROCTER & GAMBLE MANUFACTURING COMPANY]1Current NDC, 1 package rows20250312_2fc4745c-fac9-7861-e063-6294a90a3f14.zip

Products#

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

DailyMed product names page 1 of 1 · 31 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
84126-10284126-102-39

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 29 matching rows.

Name, UNII, Kind table
NameUNIIKind
PYRUS MALUS (APPLE) FRUITB423VGH5S9IACT
SANTALUM ALBUM (SANDALWOOD)3641YW25N2IACT
DIMETHICONE92RU3N3Y1OIACT
PRUNUS ARMENIACA (APRICOT) FRUIT EXTRACT269CJD5GZ9IACT
CUCUMIS SATIVUS (CUCUMBER) FRUITYY7C30VXJTIACT
RUBUS IDAEUS (RASPBERRY) FRUIT4N14V5R27WIACT
MUSKMELONZV095H5633IACT
SQUALANEGW89575KF9IACT
GLYCERYL STEARATE SEFCZ5MH785IIACT
CETEARYL ALCOHOL2DMT128M1SIACT
TETRASODIUM EDTAMP1J8420LUIACT
C12-15 ALKYL BENZOATEA9EJ3J61HQIACT
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
CAPRYLYL GLYCOL00YIU5438UIACT
GLYCYRRHIZA GLABRA (LICORICE) ROOT2788Z9758HIACT
CAMELLIA SINENSIS LEAFW2ZU1RY8B0IACT

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 Cream Intense Hydration Skin Protectant Cucumber MelonCOLLOIDAL OATMEALThe Procter & Gamble Manufacturing Company2fc4745c-fac9-7861-e063-6294a90a3f142025-03-07WarningsExact identifier
ndc (package): 84126-102-39
ndc (product): 84126-102
ndc11 (package): 84126010239
spl id: 2fc472c2-d44f-ab23-e063-6394a90a879e
spl set id: 2fc4745c-fac9-7861-e063-6294a90a3f14

Reported adverse events (FAERS/openFDA)#

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