EARTH MAMA ECZEMA CREAM- colloidal oatmeal cream

Earth Mama Eczema Cream by

Drug Labeling and Warnings

Earth Mama Eczema Cream by is a Otc medication manufactured, distributed, or labeled by Earth Mama Angel Baby, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active Ingredient

Colloidal Oatmeal* 5%

Purpose

Skin Protectant

Uses

Temporarily protects and helps relieve minor skin irritation and itching due to:  rashes  eczema  poison ivy, oak, or sumac  insect bites. For use on mild to moderate eczema or as directed by a physician.

Warnings

For External Use Only

When using this product: do not get into eyes

Stop use and ask a doctor if  condition worsens  symptoms last more than 7 days or clear up and occur again within a few days.

Keep out of reach of children. If product is swallowed, get medical help or contact Poison Control Center right away.

Directions

Apply as needed.

Other Information

Store at room temperature.

Inactive Ingredients

Helianthus Annuus (Sunflower) Seed Oil*, Cocos Nucifera (Coconut) Oil*, Caprylic/Capric Triglyceride*, Olea Europaea (Olive) Fruit Oil*, Beeswax*, Butyrospermum Parkii (Shea) Butter*, Simmondsia Chinensis (Jojoba) Seed Oil*, Oenothera Biennis (Evening Primrose) Oil*, Aloe Barbadensis Leaf Powder*, Aspalathus Linearis (Rooibos) Leaf Extract*, Nigella Sativa (Black Cumin) Seed Extract*, Tocopherol, Zinc Oxide

*Organic

Questions or comments?

503-607-0607 or earthmama.com

SPL UNCLASSIFIED SECTION

THERAPEUTIC

ITCH RELIEF

Pediatrician & Dermatologist Tested

Contains Organic Rooibos & Black Cumin Seed

Steroid-free, NO Artificial Preservatives or Fragrance

NSF
contains organic ingredients

FOR EVERYONE AND THEIR MOTHER.

​ Relieves itch on contact
Moisturizing skin protectant
Relieves itch associated with eczema flare up

Distributed by Earth Mama Angel Baby® LLC
9866 SE Empire Ct. Clackamas, OR 97015 USA

Certified to the NSF/ANSI 305 Standard by Oregon Tilth

Awarded the National Eczema Association

Seal of AcceptanceTM

Leaping Bunny Certified

Packaging

INGREDIENTS AND APPEARANCE

EARTH MAMA ECZEMA CREAM 
colloidal oatmeal cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 72812-151
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OATMEAL (UNII: 8PI54V663Y) (OATMEAL - UNII:8PI54V663Y)	OATMEAL	50 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
SUNFLOWER OIL (UNII: 3W1JG795YI)
COCONUT OIL (UNII: Q9L0O73W7L)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
OLIVE OIL (UNII: 6UYK2W1W1E)
YELLOW WAX (UNII: 2ZA36H0S2V)
SHEA BUTTER (UNII: K49155WL9Y)
JOJOBA OIL (UNII: 724GKU717M)
EVENING PRIMROSE OIL (UNII: 3Q9L08K71N)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
ASPALATHUS LINEARIS LEAF (UNII: H7UGK1GJCU)
NIGELLA SATIVA SEED (UNII: 4LVZ0Z0ITT)
TOCOPHEROL (UNII: R0ZB2556P8)
ZINC OXIDE (UNII: SOI2LOH54Z)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 72812-151-01	85 g in 1 TUBE; Type 0: Not a Combination Product	01/01/2021

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M016	01/01/2021

Labeler - Earth Mama Angel Baby, LLC (603560686)