M3 NATURALS Eczema Cream: Package Insert and Label Information

M3 NATURALS ECZEMA CREAM- oatmeal cream
M3 Naturals 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.

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:

Label
(click image for full-size original)

M3 NATURALS ECZEMA CREAM
oatmeal cream
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:81985-186
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
OATMEAL (OATMEAL) OATMEAL 10 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
ALLANTOIN
ALOE VERA LEAF
WATER
SHEA BUTTER
CALENDULA OFFICINALIS FLOWER
CANNABIS SATIVA SEED OIL
MEDIUM-CHAIN TRIGLYCERIDES
CARTHAMUS TINCTORIUS FLOWER OIL
CHAMOMILE
CUCUMBER
EMU OIL
ETHYLHEXYLGLYCERIN
GLUCOSAMINE SULFATE
GLYCERIN
GLYCERYL MONOSTEARATE
LICORICE
HELIANTHUS ANNUUS FLOWERING TOP
PHENOXYETHANOL
POMEGRANATE
XANTHAN GUM
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:81985-186-01 118 mL in 1 JAR None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph final part347 04/19/2021
Labeler — M3 Naturals LLC (100802579)

Revised: 06/2021 M3 Naturals LLC

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