FDA.reportPublic FDA data

Hylands Naturals Eczema Lotion

Manufacturer
Hylands
Effective date
2023-01-03
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
legacy-cache
Hydrated at
2026-08-01 21:41:48

Label at a glance#

ProductHylands Naturals Eczema
Active ingredientOATMEAL
Label structure10 sections

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

Active ingredients
Colloidal Oatmeal 1%

OTC - PURPOSE SECTION

Purpose
Skin protectant

INDICATIONS & USAGE SECTION

Uses
Temporarily protects and helps relieve minor skin irritation and itching due to: ■ eczema  ■ rashes

WARNINGS SECTION

Warnings
For external use only. When using this product do not get into eyes
Stop use and ask doctor if ■ condition worsens, ■ symptoms last
for more than 7 days or clear up and occur again within a few days.

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.

DOSAGE & ADMINISTRATION SECTION

Directions  ■ Apply as needed.

INACTIVE INGREDIENT SECTION

Inactive ingredients  Water,Glycerin, Dicaprylyl
Carbonate,Glyceryl Stearate Citrate, Cetearyl Olivate, Sorbitan

Olivate, Lauryl Laurate, Benzyl Alcohol, Dehydroacetic Acid, Shea

Butter, Cocoa Seed Butter, Linseed Seed Oil, Oat, Xanthan Gum,

Organic Sunflower Seed Oil, Organic Lavender Flower Extract,

Organic Calendula Officianalis Flower Extract, Organic Aloe Leaf

Juice, Hydrolized Quinoa, Panthenol, Citric Acid.

Package Labeling

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Hylands

NATURALS

• baby •

ECZEMA
LOTION

DERMATOLOGIST TESTED

NET WT. 5 OZ. (142 g)

DO NOT USE IF TAMPER-EVIDENT SEAL IS BROKEN OR MISSING.

Manufactured for: Hyland’s, Inc., PO Box 61067, Los Angeles, CA 90061
www.hylands.com | REV001

Eczema lOTIONEczema lOTION

res

Products#

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

DailyMed product names page 1 of 1 · 24 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
54973-410354973-4103-1

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 22 matching rows.

Name, UNII, Kind table
NameUNIIKind
OATMEAL8PI54V663YACTIB
WATER059QF0KO0RIACT
GLYCERINPDC6A3C0OXIACT
DICAPRYLYL CARBONATE609A3V1SUAIACT
GLYCERYL STEARATE CITRATEWH8T92A065IACT
CETEARYL OLIVATE58B69Q84JOIACT
SORBITAN OLIVATEMDL271E3GRIACT
LAURYL LAURATEGPW77G0937IACT
BENZYL ALCOHOLLKG8494WBHIACT
DEHYDROACETIC ACID2KAG279R6RIACT
SHEA BUTTERK49155WL9YIACT
COCOA BUTTER512OYT1CRRIACT
LINSEED OIL84XB4DV00WIACT
OATZ6J799EAJKIACT
XANTHAN GUMTTV12P4NEEIACT
SUNFLOWER OIL3W1JG795YIIACT
LAVANDULA ANGUSTIFOLIA SUBSP. ANGUSTIFOLIA FLOWER19AH1RAF4MIACT
CALENDULA OFFICINALIS FLOWERP0M7O4Y7YDIACT
ALOE VERA LEAFZY81Z83H0XIACT
CHENOPODIUM QUINOA SEEDOO4K72NZ2XIACT
PANTHENOLWV9CM0O67ZIACT
ANHYDROUS CITRIC ACIDXF417D3PSLIACT

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
3e7e8b1f-7fe1-4b88-b9a9-0fb0761bb8e803455f02-3bad-4f4d-be9d-3ce4ae374ff52023-01-03WarningsExact identifier
spl id: 3e7e8b1f-7fe1-4b88-b9a9-0fb0761bb8e8
spl set id: 03455f02-3bad-4f4d-be9d-3ce4ae374ff5

Reported adverse events (FAERS/openFDA)#

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