Our Eczema Remedy - 84073-100-01

Our Eczema Remedy - 84073-100-01
SPL v1
SPL
SPL Set ID 3a755b4c-47c8-9ca5-e063-6394a90af84a
Route
TOPICAL
Published
Effective Date 2025-07-21
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Oatmeal (1.8 g)
Inactive Ingredients
Sodium Hyaluronate Cocos Nucifera (coconut) Oil Sodium Stearoyl Glutamate Sorbitan Olivate Theobroma Cacao (cocoa) Seed Butter Sodium Phytate Allantoin Cetearyl Alcohol Propanediol Coco-caprylate/caprate Lactobacillus Sodium Lauroyl Glutamate Xanthan Gum Potassium Hydroxide Caprylhydroxamic Acid Coconut Alkanes Cetearyl Olivate Butyrospermum Parkii (shea) Butter Glyceryl Stearate Helianthus Annuus (sunflower) Seed Oil Water Caprylic/capric Triglyceride Stearic Acid Alpha-glucan Oligosaccharide Glycerin Polymnia Sonchifolia Root Juice Leuconostoc/radish Root Ferment Filtrate Maltodextrin Citric Acid Mangifera Indica Seed Butter Aloe Barbadensis Leaf Juice Squalane 1,2-hexanediol

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-07-21

Description

Drug Facts

Purpose

Skin protectant


Medication Information

Purpose

Skin protectant

Description

Drug Facts

Uses

Temporarily protects and helps relieve minor skin irritation and itching due to: • Eczema • Rashes

Section 51945-4

Warnings

For external use only

Directions

Apply as needed

Drug Facts

Drug Facts

Questions?

(877) 788-6378 healthybaby.com

Other Information

• Remove quality seal. Do not use if quality seal is broken

• For use on mild to moderate eczema or as directed by a physician

• Store at room temperature

Active Ingredients

Colloidal Oatmeal 1.8%

Inactive Ingredients

Water (Aqua), Caprylic/Capric Triglyceride, Coconut Alkanes, Stearic Acid, Coco-Caprylate/Caprate, Cetearyl Alcohol, Glycerin, Theobroma Cacao Seed Butter*, Helianthus Annuus Seed Oil*, Mangifera Indica Seed Butter, Propanediol, Cetearyl Olivate, Cocos Nucifera (Coconut) Oil*, Sodium Stearoyl Glutamate, Sorbitan Olivate, Butyrospermum Parkii (Shea) Butter*, Allantoin, Aloe Barbadensis Leaf Juice*, Alpha-Glucan Oligosaccharide, Sodium Hyaluronate, Polymnia Sonchifolia Root Juice, Leuconostoc/Radish Root Ferment Filtrate, Maltodextrin, Lactobacillus, Sodium Lauroyl Glutamate, Squalane, Glyceryl Stearate, Xanthan Gum, 1,2-Hexanediol, Sodium Phytate, Caprylhydroxamic Acid, Potassium Hydroxide, Citric Acid. *Certified Organic Ingredient

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 swallowed, get medical help or contact a Poison Control Center right away


Structured Label Content

Uses

Temporarily protects and helps relieve minor skin irritation and itching due to: • Eczema • Rashes

Section 51945-4 (51945-4)

Purpose

Skin protectant

Warnings

For external use only

Directions

Apply as needed

Drug Facts

Drug Facts

Questions?

(877) 788-6378 healthybaby.com

Other Information

• Remove quality seal. Do not use if quality seal is broken

• For use on mild to moderate eczema or as directed by a physician

• Store at room temperature

Active Ingredients

Colloidal Oatmeal 1.8%

Inactive Ingredients

Water (Aqua), Caprylic/Capric Triglyceride, Coconut Alkanes, Stearic Acid, Coco-Caprylate/Caprate, Cetearyl Alcohol, Glycerin, Theobroma Cacao Seed Butter*, Helianthus Annuus Seed Oil*, Mangifera Indica Seed Butter, Propanediol, Cetearyl Olivate, Cocos Nucifera (Coconut) Oil*, Sodium Stearoyl Glutamate, Sorbitan Olivate, Butyrospermum Parkii (Shea) Butter*, Allantoin, Aloe Barbadensis Leaf Juice*, Alpha-Glucan Oligosaccharide, Sodium Hyaluronate, Polymnia Sonchifolia Root Juice, Leuconostoc/Radish Root Ferment Filtrate, Maltodextrin, Lactobacillus, Sodium Lauroyl Glutamate, Squalane, Glyceryl Stearate, Xanthan Gum, 1,2-Hexanediol, Sodium Phytate, Caprylhydroxamic Acid, Potassium Hydroxide, Citric Acid. *Certified Organic Ingredient

When Using This Product (When using this product)

• Do not get into eyes

Stop Use and Ask A Doctor If (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. (Keep out of reach of children.)

If swallowed, get medical help or contact a Poison Control Center right away


Advanced Ingredient Data


Raw Label Data

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