FDA.reportPublic FDA data

Eczema Relief Cream

Manufacturer
HEMPFUSION, INC. | Universal Packaging Systems, Inc. (DBA Paklab)
Effective date
2021-03-17
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-05-31 23:39:02

Label at a glance#

ProductEczema Relief Cream
Active ingredientOATMEAL
Label structure9 sections

Indications and uses

Temporarily protects and helps relieve minor skin irritation and itching due to: eczema poison ivy, oak or sumac insect bites

Dosage and administration

Apply as needed.

Storage and handling

Store in a cool dry place away from light

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Colloidal Oatmeal 1%

Purpose

OTC - PURPOSE SECTION

Colloidal Oatmeal 1%...Skin Protectant

Uses

INDICATIONS & USAGE SECTION

Temporarily protects and helps relieve minor skin irritation and itching due to:

  • eczema
  • poison ivy, oak or sumac
  • insect bites

Warnings

WARNINGS SECTION

For external use only

OTC - WHEN USING SECTION

When using this product

  • do not get into eyes

OTC - STOP USE SECTION

Stop use and ask doctor if

  • condition worsens
  • symptoms persist for more than 7 days or clear up and occur again within a few days

OTC - PREGNANCY OR BREAST FEEDING SECTION

If pregnant or breastfeeding, ask a health professional before use.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reacho f children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

Apply as needed.

Other information

STORAGE AND HANDLING SECTION

  • Store in a cool dry place away from light

Inactive ingredients

INACTIVE INGREDIENT SECTION

water (aqua), coco-caprylate, organic shea (butyrospermum parkii) butter, organic jojoba (simmondsia chinensis) seed oil, glycerin, methylsulfonylmethane (MSM), cetearyl alcohol, cetearyl olivate, organic hemp (cannabis sativa) aerial part extract, organic hemp (cannabis sativa) seed oil, sorbitan olivate, organic aloe (aloe barbadensis) leaf juice, cetearyl glucoside, ethylhexylglycerin, glucose,

allantoin, xanthan gum, linalool, limonene, lactoperoxidase, glucose oxidase, organic lavender (lavandula angustifolia) oil, black pepper (piper nigrum) fruit oil, clove (syzygium aromaticum) flower oil, organic geranium (pelargonium graveolens) flower oi

Questions or comments?

OTC - QUESTIONS SECTION

Call 877-669-4367 Monday through Friday, 9am-5pm EST.

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

HempFusion

Eczema

Relief

CREAM

Colloidal Oatmeal 1%

Including nourishing Aloe Vera, hemp extract with naturally occuring CBD (100mg/bottle) + Terpenes (60mg/bottle) from black pepper and clove & other natural skin moisturizers

U.S. Hemp Authority H Certified

NON-GMO

ALL SKIN TYPES

50mL (1.69 fl oz)

BoxBoxLabelLabel

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
240651colloidal oatmeal 1 % Topical CreamPSN3
240651colloidal oatmeal 10 MG/ML Topical CreamSCD3
240651Avena sativa 1 % Topical CreamSY3
240651colloidal oatmeal 1 % Topical CreamSY3

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
OATMEAL Pharmacologic Class Indexing2Indexing - Pharmacologic Class20181113

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
cb89b86a-369e-4204-8910-ae797c503af3Product name120230706
d4880ace-a516-8c47-8dfd-73a4ba5887d7Product name220180830
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
73672-983-502024-01-30C16284748780-11030e365-3115-111a-e063-dadaa90a10e2Eczema Relief Cream

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
73672-983-50Eczema Relief Cream50 mL in 1 TUBECREAM503
73672-983-50Eczema Relief Cream1 in 1 CARTONCREAM13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
73672-983ECZEMA RELIEF CREAM (COLLOIDAL OATMEAL 1%) CREAM [HEMPFUSION, INC.]3Legacy NDC, 2 package rows20210319_9ede0d4a-fe5f-7400-e053-2995a90a9675.zip

Products#

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

DailyMed product names page 1 of 1 · 28 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
73672-98373672-983-50

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 26 matching rows.

Name, UNII, Kind table
NameUNIIKind
LIMONENE, (+)-GFD7C86Q1WIACT
ALOEV5VD430YW9IACT
ETHYLHEXYLGLYCERIN147D247K3PIACT
ALLANTOIN344S277G0ZIACT
LINALOOL, (+/-)-D81QY6I88EIACT
MYELOPEROXIDASEJQZ6YM58U5IACT
GLUCOSE OXIDASE0T8392U5N1IACT
LAVENDER OILZBP1YXW0H8IACT
CETOSTEARYL ALCOHOL2DMT128M1SIACT
SORBITAN OLIVATEMDL271E3GRIACT
SHEA BUTTERK49155WL9YIACT
GLYCERINPDC6A3C0OXIACT
WATER059QF0KO0RIACT
COCO-CAPRYLATE4828G836N6IACT
JOJOBA OIL724GKU717MIACT
DIMETHYL SULFONE9H4PO4Z4FTIACT
CETEARYL OLIVATE58B69Q84JOIACT
HEMPTD1MUT01Q7IACT
CANNABIS SATIVA SEED OIL69VJ1LPN1SIACT
CETEARYL GLUCOSIDE09FUA47KNAIACT
ANHYDROUS DEXTROSE5SL0G7R0OKIACT
XANTHAN GUMTTV12P4NEEIACT
BLACK PEPPER OILU17J84S19ZIACT
CLOVE OIL578389D6D0IACT
PELARGONIUM GRAVEOLENS FLOWER OIL3K0J1S7QGCIACT
OATMEAL8PI54V663YACTIB

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
bdc68734-381f-0f6a-e053-2a95a90ae26f9ede0d4a-fe5f-7400-e053-2995a90a96752021-03-17WarningsExact identifier
spl id: bdc68734-381f-0f6a-e053-2a95a90ae26f
spl set id: 9ede0d4a-fe5f-7400-e053-2995a90a9675

Reported adverse events (FAERS/openFDA)#

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