SMITH AMISH ECZEMA/PSORIASIS- colloidal oatmeal cream
Smith Amish, LLC

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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

Drug Facts

Active Ingredient

Colloidal Oatmeal 2%

Purpose

Skin Protectant

Uses

Temporarily relieves or controls symptoms associated with eczema/psoriasis

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)

label

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

Smith Amish, LLC