ECZEMA- colloidal oatmeal cream

ECZEMA by

Drug Labeling and Warnings

ECZEMA by is a Otc medication manufactured, distributed, or labeled by Smith Amish, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts Active Ingredient

Colloidal Oatmeal 2.0%

Purpose

Skin Protectant

Uses

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

Warnings

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

• 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.

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 the affected area as needed. Not recommended for face.

Other information

Protect from excessive heat

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

Inactive Ingredients

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?

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

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)

INGREDIENTS AND APPEARANCE

ECZEMA 
colloidal oatmeal cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 72609-704
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OATMEAL (UNII: 8PI54V663Y) (OATMEAL - UNII:8PI54V663Y)	OATMEAL	1.25 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
ALMOND OIL (UNII: 66YXD4DKO9)
JOJOBA OIL (UNII: 724GKU717M)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
PEPPERMINT OIL (UNII: AV092KU4JH)
.ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)
ARNICA MONTANA WHOLE (UNII: O80TY208ZW)
CETYL PALMITATE (UNII: 5ZA2S6B08X)
SODIUM CITRATE (UNII: 1Q73Q2JULR)
STEARIC ACID (UNII: 4ELV7Z65AP)
TEA TREE OIL (UNII: VIF565UC2G)
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
PANTHENOL (UNII: WV9CM0O67Z)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 72609-704-02	1 in 1 BOX	08/28/2024
1		59 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M016	08/28/2024

Labeler - Smith Amish, LLC (081504527)