FDA.reportPublic FDA data

Smith Amish Eczema/Psoriasis Cream (NDC: 72609-202-40)

Manufacturer
Smith Amish, LLC
Effective date
2022-04-04
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
legacy-cache
Hydrated at
2026-08-01 22:04:32

Label at a glance#

ProductSmith Amish Eczema/Psoriasis
Active ingredientOATMEAL
Label structure10 sections

Indications and uses

Temporarily relieves or controls symptoms associated with eczema/psoriasis

Dosage and administration

Adults and children 5 years and over apply gently to affected area up to 4 times per day. Not recommended for face.

Label contents#

Full prescribing information#

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

Active Ingredient

Colloidal Oatmeal 2%

Purpose

OTC - PURPOSE SECTION

Skin Protectant

Uses

INDICATIONS & USAGE SECTION

Temporarily relieves or controls symptoms associated with eczema/psoriasis

WARNINGS SECTION

For external use only

Avoid contact with eyes.

OTC - STOP USE SECTION

If condition worsens, or if symptoms persist for more than 7 days or no imporivement within a few days, discontinue use of the product and consult a doctor.

OTC - DO NOT USE SECTION

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 affected area up to 4 times per day.

Not recommended for face.

Other Information

OTHER SAFETY INFORMATION

Protect from excessive heat

Store at 20-25 degrees C (68-77 Farenheit)

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Arnica montana flower extract, cetyl palmitate, tea tree (Melaluca Alternifolia) oil, DO panthenol (Provitamin B5), ethylhexylglycerin, glycerin, glyceryl stearate, jojoba (Buxus Chinensis) oil, peppermint (mentha piperita) oil, phenoxyethanol, sodium citrate, stearic acid, sweet almond (prunus amygdalus dulcis) oil, tocopherol acetate (vitamin E), water

Questions?

OTC - QUESTIONS SECTION

Call (866) 419-3567

Monday through friday 8:00am - 4:00pm ET

Drug Product Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Smith Amish Eczema/Psoriasis

Deep Moisturizing Cream

Sensitive, Distressed, Dry, Scaly Skin

(NDC: 72609-202-40)

labellabel

Products#

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

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

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
72609-20272609-202-40

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
NameUNIIKind
ETHYLHEXYLGLYCERIN147D247K3PIACT
GLYCERYL STEARATE SEFCZ5MH785IIACT
SODIUM CITRATE1Q73Q2JULRIACT
ALMOND OIL66YXD4DKO9IACT
WATER059QF0KO0RIACT
CETYL PALMITATE5ZA2S6B08XIACT
JOJOBA OIL724GKU717MIACT
PHENOXYETHANOLHIE492ZZ3TIACT
STEARIC ACID4ELV7Z65APIACT
OATMEAL8PI54V663YACTIB
PANTHENOLWV9CM0O67ZIACT
TEA TREE OILVIF565UC2GIACT
TOCOPHEROLR0ZB2556P8IACT
GLYCERINPDC6A3C0OXIACT
ARNICA MONTANA FLOWEROZ0E5Y15PZIACT

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
f8349dc0-565a-5cc0-e053-6294a90a1fabdbda2ed8-76a2-dc42-e053-2a95a90a1f512023-03-31WarningsExact identifier
spl set id: dbda2ed8-76a2-dc42-e053-2a95a90a1f51

Reported adverse events (FAERS/openFDA)#

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