M3 NATURALS ECZEMA CREAM- oatmeal cream

M3 NATURALS Eczema Cream by

Drug Labeling and Warnings

M3 NATURALS Eczema Cream by is a Otc medication manufactured, distributed, or labeled by M3 Naturals LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts:

Active Ingredient

Colloidal Oatmeal 1%

Purpose

Skin Protectant

Indications:

Temporarily protects and helps relieve minor skin irritation and itching due to ■ Eczema or ■ rashes.

Warnings:

■ For external use only.  ■ Avoid contact with eyes.

Stop use and ask a doctor if:

• condition worsens,
• symptoms last for more than 7 days, or clear up and occur again within a few days.

Keep out of reach of children.

• If swallowed, consult physician.

Directions:

• Adults and children two-years of age or older: Apply as needed
• Children under two-years of age: consult a physician.

Additional Information:

for use on mild to moderate Eczema or as directed by physician. Store at room temperature.

Other Ingredients:

Allantoin, Aloe Barbadensis Leaf (Aloe Vera Gel) Juice, Aqua (Deionized Water), a-Bisabalol, Butyrospermum Parkii (Shea) Butter, Calendula Officinalis Extract, Cannabis Sativa (Organic Hemp) Seed Oil, Caprylic/Capric Triglyceride, Carthamus Tinctorius (Safflower) Oil, Chamomilla Recutita (Chamomile) Extract, Cucumis Sativus (Cucumber) Extract, Emu Oil, Emulsifying Wax NF, Ethylhexylglycerin, Glucosamine Sulfate, Glycerin, Glyceryl Stearate, Glycyrrhiza Glabra (Licorice) Extract, Helianthus Annuus (Sunflower) Oil, Parfum (Fragrance), Phenoxyethanol, Punica Granatum (Pomegranate) Extract, Xanthan Gum.

Package Labeling:

INGREDIENTS AND APPEARANCE

M3 NATURALS ECZEMA CREAM 
oatmeal cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 81985-186
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OATMEAL (UNII: 8PI54V663Y) (OATMEAL - UNII:8PI54V663Y)	OATMEAL	10 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
ALLANTOIN (UNII: 344S277G0Z)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
WATER (UNII: 059QF0KO0R)
SHEA BUTTER (UNII: K49155WL9Y)
CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD)
CANNABIS SATIVA SEED OIL (UNII: 69VJ1LPN1S)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
CARTHAMUS TINCTORIUS FLOWER OIL (UNII: SDQ136WIM5)
CHAMOMILE (UNII: FGL3685T2X)
CUCUMBER (UNII: YY7C30VXJT)
EMU OIL (UNII: 344821WD61)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
GLUCOSAMINE SULFATE (UNII: 1FW7WLR731)
GLYCERIN (UNII: PDC6A3C0OX)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
LICORICE (UNII: 61ZBX54883)
HELIANTHUS ANNUUS FLOWERING TOP (UNII: BKJ0J3D1BP)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
POMEGRANATE (UNII: 56687D1Z4D)
XANTHAN GUM (UNII: TTV12P4NEE)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 81985-186-01	118 mL in 1 JAR; Type 0: Not a Combination Product	04/19/2021

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M016	04/19/2021

Labeler - M3 Naturals LLC (100802579)