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NDC 72609-0202-40 Smith Amish Eczema/Psoriasis 2 g/100g Details

Smith Amish Eczema/Psoriasis 2 g/100g

Smith Amish Eczema/Psoriasis is a TOPICAL CREAM in the HUMAN OTC DRUG category. It is labeled and distributed by Smith Amish, LLC. The primary component is OATMEAL.

Product Information

NDC	72609-0202
Product ID	72609-202_dbda2d0e-c191-206a-e053-2995a90af6cf
Associated GPIs
GCN Sequence Number	n/a
GCN Sequence Number Description	n/a
HIC3	n/a
HIC3 Description	n/a
GCN	n/a
HICL Sequence Number	n/a
HICL Sequence Number Description	n/a
Brand/Generic	n/a
Proprietary Name	Smith Amish Eczema/Psoriasis
Proprietary Name Suffix	n/a
Non-Proprietary Name	COLLOIDAL OATMEAL
Product Type	HUMAN OTC DRUG
Dosage Form	CREAM
Route	TOPICAL
Active Ingredient Strength	2
Active Ingredient Units	g/100g
Substance Name	OATMEAL
Labeler Name	Smith Amish, LLC
Pharmaceutical Class	Allergens [CS], Cell-mediated Immunity [PE], Dietary Proteins [CS], Grain Proteins [EXT], Increased Histamine Release [PE], Non-Standardized Food Allergenic Extract [EPC], Non-Standardized Plant Allergenic Extract [EPC], Plant Proteins [CS]
DEA Schedule	n/a
Marketing Category	OTC MONOGRAPH FINAL
Application Number	part347
Listing Certified Through	2023-12-31

Package

Package Images

NDC 72609-0202-40 (72609020240)

Pricing Information	N/A
NDC Package Code	72609-202-40
Billing NDC	72609020240
Package	114 g in 1 JAR (72609-202-40)
Marketing Start Date	2022-04-04
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL dbda2ed8-76a2-dc42-e053-2a95a90a1f51 Details

Drug Facts

Active Ingredient

Colloidal Oatmeal 2%

Purpose

Skin Protectant

Uses

Temporarily relieves or controls symptoms associated with eczema/psoriasis

SPL UNCLASSIFIED SECTION

For external use only

Avoid contact with eyes.

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.

Do not apply to wounds or damaged skin. Do not bandage tightly.

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

Keep out of reach of children.

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

Directions

Adults and children 5 years and over apply gently to affected area up to 4 times per day.

Not recommended for face.

Other Information

Protect from excessive heat

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

Inactive Ingredients

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?

Call (866) 419-3567

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

Drug Product Label

Smith Amish Eczema/Psoriasis

Deep Moisturizing Cream

Sensitive, Distressed, Dry, Scaly Skin

(NDC: 72609-202-40)

INGREDIENTS AND APPEARANCE

SMITH AMISH ECZEMA/PSORIASIS

colloidal oatmeal cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:72609-202
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
OATMEAL (UNII: 8PI54V663Y) (OATMEAL - UNII:8PI54V663Y)	OATMEAL	2 g in 100 g

Ingredient Name	Strength
Inactive Ingredients
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
GLYCERYL STEARATE SE (UNII: FCZ5MH785I)
SODIUM CITRATE (UNII: 1Q73Q2JULR)
ALMOND OIL (UNII: 66YXD4DKO9)
WATER (UNII: 059QF0KO0R)
CETYL PALMITATE (UNII: 5ZA2S6B08X)
JOJOBA OIL (UNII: 724GKU717M)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
STEARIC ACID (UNII: 4ELV7Z65AP)
PANTHENOL (UNII: WV9CM0O67Z)
TEA TREE OIL (UNII: VIF565UC2G)
TOCOPHEROL (UNII: R0ZB2556P8)
GLYCERIN (UNII: PDC6A3C0OX)
ARNICA MONTANA FLOWER (UNII: OZ0E5Y15PZ)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:72609-202-40	114 g in 1 JAR; Type 0: Not a Combination Product	04/04/2022

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part347	04/04/2022

Labeler - Smith Amish, LLC (081504527)

Revised: 4/2022

Document Id: dbda2d0e-c191-206a-e053-2995a90af6cf

Set id: dbda2ed8-76a2-dc42-e053-2a95a90a1f51

Version: 1

Effective Time: 20220404