Earth Mama ​®

Earth Mama ​®
SPL v5
SPL
SPL Set ID bd30b525-f68c-4786-9fbc-745e2634c6bb
Route
TOPICAL
Published
Effective Date 2022-02-07
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Oatmeal (50 mg)
Inactive Ingredients
Sunflower Oil Coconut Oil Medium-chain Triglycerides Olive Oil Yellow Wax Shea Butter Jojoba Oil Evening Primrose Oil Aloe Vera Leaf Aspalathus Linearis Leaf Nigella Sativa Seed Tocopherol Zinc Oxide

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Completed Since 2021-01-01 Until 2026-12-31

Description

Colloidal Oatmeal* 5%

Purpose

Skin Protectant


Medication Information

Purpose

Skin Protectant

Description

Colloidal Oatmeal* 5%

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.

Section 42229-5

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 Acceptance TM

Leaping Bunny Certified

Section 50565-1

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

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.

Packaging

Directions

Apply as needed.

Drug Facts

Active Ingredient

Colloidal Oatmeal* 5%

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


Structured Label Content

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.

Section 42229-5 (42229-5)

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 Acceptance TM

Leaping Bunny Certified

Section 50565-1 (50565-1)

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

Purpose

Skin Protectant

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.

Packaging

Directions

Apply as needed.

Drug Facts

Active Ingredient

Colloidal Oatmeal* 5%

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? (Questions or comments?)

503-607-0607 or earthmama.com


Advanced Ingredient Data


Raw Label Data

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