ECZEMA

Manufacturer: Smith Amish, LLC
Effective date: 2025-12-12
Label type: HUMAN OTC DRUG LABEL
Version: 5
Source: full-release
Hydrated at: 2026-06-01 01:22:38

Label at a glance#

ProductECZEMA

Active ingredientOATMEAL

Label structure11 sections

Indications and uses

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

Dosage and administration

Adults and children 5 years and over apply gently to the affected area as needed. Not recommended for face.

Contacts and useful links#

PhoneLabel contact(866) 419-3567

Label contents#

Full prescribing information#

Drug Facts Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Colloidal Oatmeal 2.0%

Purpose

OTC - PURPOSE SECTION

Skin Protectant

Uses

INDICATIONS & USAGE SECTION

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

Warnings

WARNINGS SECTION

For external use only
When using this product do not get into eyes

OTC - STOP USE SECTION

If condition worsens, or if symptoms persist for more than 7 days or clear up and occur again within a few days,, discontinue use of this product and consult a doctor.
Do not apply to wounds or damaged skin.
Do not bandage tightly.

OTC - PREGNANCY OR BREAST FEEDING SECTION

If pregnant or breast-feeding, ask a health professional before use.

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

Adults and children 5 years and over apply gently to the affected area as needed. Not recommended for face.

Other information

OTHER SAFETY INFORMATION

Protect from excessive heat

Store at 20-25 ^oC (68-77F)

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Arnica montana flower extract, cetyl palmitate, ethylhexylglycerin, eucalyptus (Eucalyptus cinerea), glycerin, glyceryl stearate, jojoba (Buxus chinensis) oil, peppermint (mentha piperita) oil, phenoxyethanol, rosemary (Rosmariunus officinalis) oil, sodium citrate, stearic acid, sweet almond (Prunus amydgalus dulcis) oil, tea tree (Melaleuca alternifolia) oil, tocopherol (Vitamin E), water

Questions?

OTC - QUESTIONS SECTION

Call (866) 419-3567

Monday through Friday 8:00am - 2:00pm ET

SPL UNCLASSIFIED SECTION

Tamper evident: Do not use if safety seal under cap is broken or missing.

Manufactured for Smith Amish LLC 16350 N Hwy 329 Reddick, FL 32634

Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Smith Amish Eczema Cream (72609-704-02)

Deep Moisturizing Cream

for sensitive, distressed, dry, scaly skin

Clean Fresh Scent

Easily Absorbed and Non-Greasy

Net wt. 2oz (59g)

labels

DailyMed Pharmacologic Classes#

Class, Version, Type table
Class	Version	Type	Effective
OATMEAL Pharmacologic Class Indexing	2	Indexing - Pharmacologic Class	20181113

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
d5e51f11-ad28-caa4-4b49-4143974782ad	Product name	1	20150831

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
72609-704-02	2025-07-29	C162847	48780-1	3b156c62-24eb-fb37-e063-e6dba90a4e07	Smith Amish Eczema Cream (2oz) - 72609-704-02; Smith Amish Eczema Cream (4oz) - 72609-704-04

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
72609-704-04	ECZEMA	113 g in 1 JAR	CREAM	113		5

Products#

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

DailyMed product names page 1 of 1 · 17 matching rows.

ECZEMA
COLLOIDAL OATMEAL
ALMOND OIL
OATMEAL
JOJOBA OIL
GLYCERYL MONOSTEARATE
PEPPERMINT OIL
.ALPHA.-TOCOPHEROL
ARNICA MONTANA WHOLE
CETYL PALMITATE
SODIUM CITRATE
STEARIC ACID
TEA TREE OIL
WATER
GLYCERIN
PHENOXYETHANOL
PANTHENOL

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
72609-704	72609-704-04

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 15 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
ALMOND OIL	66YXD4DKO9	IACT
OATMEAL	8PI54V663Y	ACTIB
JOJOBA OIL	724GKU717M	IACT
GLYCERYL MONOSTEARATE	230OU9XXE4	IACT
PEPPERMINT OIL	AV092KU4JH	IACT
.ALPHA.-TOCOPHEROL	H4N855PNZ1	IACT
ARNICA MONTANA WHOLE	O80TY208ZW	IACT
CETYL PALMITATE	5ZA2S6B08X	IACT
SODIUM CITRATE	1Q73Q2JULR	IACT
STEARIC ACID	4ELV7Z65AP	IACT
TEA TREE OIL	VIF565UC2G	IACT
WATER	059QF0KO0R	IACT
GLYCERIN	PDC6A3C0OX	IACT
PHENOXYETHANOL	HIE492ZZ3T	IACT
PANTHENOL	WV9CM0O67Z	IACT

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
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
ECZEMA	COLLOIDAL OATMEAL	Smith Amish, LLC	20c4bc16-ba20-47ec-e063-6394a90a8b4e	2025-12-12	Warnings	Exact identifier ndc (package): 72609-704-04 ndc (product): 72609-704 ndc11 (package): 72609070404 spl id: 45c89ca7-3354-d315-e063-6394a90ac647 spl set id: 20c4bc16-ba20-47ec-e063-6394a90a8b4e

Reported adverse events (FAERS/openFDA)#

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