M3 NATURALS ECZEMA CREAM- oatmeal cream 
M3 Naturals LLC

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M3 NATURALS: Eczema Cream

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:

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:

Label

M3 NATURALS ECZEMA CREAM 
oatmeal cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:81985-186
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OATMEAL (UNII: 8PI54V663Y) (OATMEAL - UNII:8PI54V663Y) OATMEAL10 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:81985-186-01118 mL in 1 JAR; Type 0: Not a Combination Product04/19/2021
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM01604/19/2021
Labeler - M3 Naturals LLC (100802579)

Revised: 11/2023
Document Id: 09e2e2ce-d85c-0711-e063-6294a90a9213
Set id: 45e2cdde-58fb-4eea-a54d-f53f9ad0d854
Version: 2
Effective Time: 20231111
 
M3 Naturals LLC