FDA.reportPublic FDA data

FIRST AID BEAUTY FAB ULTRA REPAIR SKIN PROTECTANT Kit

Manufacturer
The Procter & Gamble Manufacturing Company
Effective date
2026-09-04
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
daily-update
Hydrated at
2026-09-08 02:01:26

Label at a glance#

ProductFIRST AID BEAUTY FAB ULTRA REPAIR SKIN PROTECTANT Kit
Active ingredientOATMEAL
Label structure10 sections

Indications and uses

Temporarily protects and helps relieve minor skin irritation and itching due to exzema 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 ingredient

OTC - ACTIVE INGREDIENT SECTION

Colloidal oatmeal 0.50%

Purpose

OTC - PURPOSE SECTION

Skin Protectant

Uses

INDICATIONS & USAGE SECTION

Temporarily protects and helps relieve minor skin irritation and itching due to exzema 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.

When using this product

OTC - WHEN USING SECTION

Do not get into eyes

Stop use and ask a doctor if

OTC - STOP USE SECTION

  • 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 ingredients

INACTIVE INGREDIENT SECTION

Water, stearic acid, glycerin, C12-15 alkyl benzoate, caprylic/capric triglyceride, glyceryl stearate SE, glyceryl stearate, cetearyl alcohol, dimethicone, squalane, hydrogenated 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 (or comments)?

OTC - QUESTIONS SECTION

888-FAB-3063

SPL UNCLASSIFIED SECTION

MADE IN USA WITH LOCAL AND

IMPORTED MATERIALS.

DISTR. BY: FIRST AID BEAUTY LTD

NEWTON, MA 02458.

FIRSTAIDBEAUTY.COM

PRINCIPAL DISPLAY PANEL - Kit

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

FIRST AID BEAUTY

DESIGNED FOR SENSITIVE SKIN

ULTRA REPAIR CREAM

TRAVEL SIZE

FULL SIZE

NET WT. 56.7 g (2 OZ)

NET WT. 170.1 g (6 OZ)

FABFAB

FAB2FAB2

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-130810160802174GTIN-13: 0810160802174
EAN-13: 0810160802174
GTIN-12: 810160802174
UPC-A: 810160802174
GTIN storage (14 digits): 00810160802174		FAB2.jpg

Products#

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

DailyMed product names page 1 of 1 · 26 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
84126-91284126-912-01
69423-55669423-556-17, 69423-556-57

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
OATMEAL8PI54V663YACTIB
TANACETUM PARTHENIUM FLOWER7TVV9D7I89IACT
STEARIC ACID4ELV7Z65APIACT
SQUALANEGW89575KF9IACT
CERAMIDE NP4370DF050BIACT
GLYCERINPDC6A3C0OXIACT
GLYCERYL STEARATE SEFCZ5MH785IIACT
C12-15 ALKYL BENZOATEA9EJ3J61HQIACT
SHEA BUTTERK49155WL9YIACT
CAMELLIA SINENSIS LEAFW2ZU1RY8B0IACT
WATER059QF0KO0RIACT
CETOSTEARYL ALCOHOL2DMT128M1SIACT
CAPRYLIC/CAPRIC TRIGLYCERIDEC9H2L21V7UIACT
SODIUM HYDROXIDE55X04QC32IIACT
PHENOXYETHANOLHIE492ZZ3TIACT
GLYCYRRHIZA GLABRA (LICORICE) ROOT2788Z9758HIACT
XANTHAN GUMTTV12P4NEEIACT
CAPRYLYL GLYCOL00YIU5438UIACT
ALLANTOIN344S277G0ZIACT
EDETATE DISODIUM7FLD91C86KIACT
EUCALYPTUS OIL2R04ONI662IACT
GLYCERYL STEARATE230OU9XXE4IACT
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 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
FIRST AID BEAUTY FAB ULTRA REPAIR SKIN PROTECTANT KitCOLLOIDAL OATMEALThe Procter & Gamble Manufacturing Company5a9aaca8-474a-0393-e063-6394a90a5a3a2026-09-04WarningsExact identifier
ndc (package): 69423-556-57
ndc (package): 69423-556-17
ndc (package): 84126-912-01
ndc (product): 84126-912
ndc11 (package): 84126091201
ndc11 (package): 69423055617
ndc11 (package): 69423055657
spl id: 5aab030d-bafe-d742-e063-6394a90a346e
spl set id: 5a9aaca8-474a-0393-e063-6394a90a5a3a
First Aid Beauty FAB Ultra Repair Skin ProtectantCOLLOIDAL OATMEALThe Procter & Gamble Manufacturing Companybeb22d69-8a83-65dc-e053-2a95a90ad8122025-12-08WarningsExact identifier
ndc (package): 69423-556-57
ndc (package): 69423-556-17
ndc (product): 69423-556
ndc11 (package): 69423055617
ndc11 (package): 69423055657

Reported adverse events (FAERS/openFDA)#

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