FDA.reportPublic FDA data

Oatmeal

Manufacturer
Save A Lot Food Stores LTD | Vi Jon
Effective date
2015-12-01
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
legacy-cache
Hydrated at
2026-08-02 01:29:50

Label at a glance#

ProductOatmeal
Active ingredientDIMETHICONE
Label structure14 sections

Dosage and administration

apply as necessary

Label contents#

Full prescribing information#

claims

SPL UNCLASSIFIED SECTION

Oatmeal

Lotion

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Dimethicone 1.3%

Purpose

OTC - PURPOSE SECTION

Skin protectant

use

INDICATIONS & USAGE SECTION

  • helps prevent and temporarily protects chafed, chapped, or cracked skin
  • helps protect from the drying effects of wind and cold weather

Warnings

WARNINGS SECTION

For external use only

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

Do not use on 

OTC - DO NOT USE SECTION

  • deep or puncture wounds
  • animal bites
  • serious burns

Keep out of reach of children

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If swallowed, get medical help or contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

apply as necessary

Inactive ingredients

INACTIVE INGREDIENT SECTION

Avena sative (oat) kernel flour, benzyl alcohol, cetyl alcohol, distearyldimonium chloride, glycerin, isopropyl palmitate, petrolatum, sodium chloride, water

Disclaimer

SPL UNCLASSIFIED SECTION

This product is not manufactured or distributed by Johnson & Johnson Consumer Prodcuts Company, distributor of Aveeno Active Naturals Daily Moisturizing Lotion

Adverse Reactions

ADVERSE REACTIONS SECTION

DISTRIBUTED BY: SAVE-A-LOT FOOD STORES, LTD

EARTH CITY, MO 63045    savealot.com

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

COMPARE TO

AVEENO

ACTIVE NATURALS

DAILY MOISTURIZING

LOTION

DAILY

MOISTURIZING

Oatmeal

Lotion

SKIN PROTECTANT

  • Relieves and Protects Dry Skin
  • Non-comedogenic
  • Fragrance Free

DERMATOLOGIST

TESTED

BEING WELL

12 FL OZ (354 mL)

image descriptionimage description

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
46994-619-322025-02-20C16284748780-19d75b9d1-035d-f424-e053-dadaa90a57cedrug facts
46994-619-322020-01-31C16284748780-19d75b9d1-035d-f424-e053-dadaa90a57cedrug facts

Products#

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

DailyMed product names page 1 of 1 · 10 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
46994-61946994-619-32

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 10 matching rows.

Name, UNII, Kind table
NameUNIIKind
DIMETHICONE92RU3N3Y1OACTIB
OATMEAL8PI54V663YIACT
BENZYL ALCOHOLLKG8494WBHIACT
CETYL ALCOHOL936JST6JCNIACT
DISTEARYLDIMONIUM CHLORIDEOM9573ZX3XIACT
GLYCERINPDC6A3C0OXIACT
ISOPROPYL PALMITATE8CRQ2TH63MIACT
PETROLATUM4T6H12BN9UIACT
SODIUM CHLORIDE451W47IQ8XIACT
WATER059QF0KO0RIACT

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
2e95dcaa-24f0-975b-e063-6394a90ac0197a921a64-34e4-467e-9b65-2e718ad541dc2025-02-20Warnings, Adverse reactionsExact identifier
spl set id: 7a921a64-34e4-467e-9b65-2e718ad541dc

Reported adverse events (FAERS/openFDA)#

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