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

Purpose

Skin Protectant

Description

Colloidal Oatmeal* 5%


Medication Information

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.

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.

Purpose

Skin Protectant

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

Description

Colloidal Oatmeal* 5%

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.

Packaging

Drug Facts

Active Ingredient

Colloidal Oatmeal* 5%

Questions Or Comments?

503-607-0607 or earthmama.com


Structured Label Content

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.

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.

Purpose

Skin Protectant

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

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.

Packaging

Drug Facts

Active Ingredient

Colloidal Oatmeal* 5%

Questions Or Comments? (Questions or comments?)

503-607-0607 or earthmama.com


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)