SPL v1
SPL
SPL Set ID 1ce11473-9d9e-4747-a6a2-361da683467f
Route
TOPICAL
Published
Effective Date 2025-03-20
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Oatmeal (1 g)
Inactive Ingredients
Water Aloe Vera Leaf Glycerin Allantoin Chamomile Sodium Pyrrolidone Carboxylate Panthenol Hyaluronate Sodium Betaine Cetostearyl Alcohol Glycereth-26 Cetyl Alcohol Sodium Chloride Jojoba Oil Citric Acid Monohydrate

Identifiers & Packaging

Marketing Status
UNAPPROVED HOMEOPATHIC Active Since 2025-03-13

Description

Colloidal Oatmeal                           Soothing and anti-inflammatory

Purpose

Colloidal Oatmeal                           Soothing and anti-inflammatory


Medication Information

Purpose

Colloidal Oatmeal                           Soothing and anti-inflammatory

Description

Colloidal Oatmeal                           Soothing and anti-inflammatory

Uses

Controls redness, dryness, and irritation associated with eczema and dermatitis.

Section 50565-1

Section 55105-1

Warnings

Do not use:

• On severe burns or su nburned skin .

• If you are allergic to ingred ients in this product.

When using this product:

• Avoid contact with eyes

• If contact occurs, rinse the eyes thoroughly with water.

Stop use and ask a doctor if:

• Rash appears

• Condition worsens or does not improve in 2-4 weeks.

If pregnant or breast-feeding. ask a doctor before use

Keep o ut of reach of children. If swallowed, get medical help o r contact a Poison Control Center right away

Directions
 Adults and children aged 12 and over.

 • Wet skin thoro ughly.

 • Dispense a small amount of foam into clean hands.

 • Gently massage onto affected areas and allow lather to sit for 1-2 minutes

 • Rinse thoroughly in the shower or bath.

 • Follow with a moisturizer or o r prescribed treatment as needed or as directed by your physician.

   For optimal results, use daily or as recommended by your dermatologist.

 Children under 12 years old .  • Ask a doctor.

Product Label

Other Information 
  • Store in a cool, dry place away from direct sunlight.
  • Keep the dispenser tightly closed when not in use to maintain product quality.
  • Keep out of reach of children.
Inactive Ingredients

Aqua 0/Vat er/Eau), Aloe Vera Leaf Juice, Glycerin, Al lantoin, Chamomile Extract, Oat Amino Aci ds, Vitamin E, Panthenol, Cucumber Extract. Sodium PCA Phenoxyet hanol. Citr ic Acid, Licorice Extract (Giycyrrhiza Glabra Root Extract). Calendula Extract (Calendula Offici nalis Flower Extract) , Shea Butter (Butyrospermum Parkii Butter) , Jojoba Oil (Simmondsia Chinensis Seed O il ), Vitamin B3 (Niacinamide), Sodium Hyaluronate (Hyaluronic Acid)

Active Ingredient                          purpose

Colloidal Oatmeal                           Soothing and anti-inflammatory


Structured Label Content

Uses

Controls redness, dryness, and irritation associated with eczema and dermatitis.

Section 50565-1 (50565-1)

Section 55105-1 (55105-1)

Warnings

Do not use:

• On severe burns or su nburned skin .

• If you are allergic to ingred ients in this product.

When using this product:

• Avoid contact with eyes

• If contact occurs, rinse the eyes thoroughly with water.

Stop use and ask a doctor if:

• Rash appears

• Condition worsens or does not improve in 2-4 weeks.

If pregnant or breast-feeding. ask a doctor before use

Keep o ut of reach of children. If swallowed, get medical help o r contact a Poison Control Center right away

Directions
 Adults and children aged 12 and over.

 • Wet skin thoro ughly.

 • Dispense a small amount of foam into clean hands.

 • Gently massage onto affected areas and allow lather to sit for 1-2 minutes

 • Rinse thoroughly in the shower or bath.

 • Follow with a moisturizer or o r prescribed treatment as needed or as directed by your physician.

   For optimal results, use daily or as recommended by your dermatologist.

 Children under 12 years old .  • Ask a doctor.

Product Label (Product label)

Other Information 
  • Store in a cool, dry place away from direct sunlight.
  • Keep the dispenser tightly closed when not in use to maintain product quality.
  • Keep out of reach of children.
Inactive Ingredients (Inactive ingredients)

Aqua 0/Vat er/Eau), Aloe Vera Leaf Juice, Glycerin, Al lantoin, Chamomile Extract, Oat Amino Aci ds, Vitamin E, Panthenol, Cucumber Extract. Sodium PCA Phenoxyet hanol. Citr ic Acid, Licorice Extract (Giycyrrhiza Glabra Root Extract). Calendula Extract (Calendula Offici nalis Flower Extract) , Shea Butter (Butyrospermum Parkii Butter) , Jojoba Oil (Simmondsia Chinensis Seed O il ), Vitamin B3 (Niacinamide), Sodium Hyaluronate (Hyaluronic Acid)

Active Ingredient                          purpose (Active Ingredient                          Purpose)

Colloidal Oatmeal                           Soothing and anti-inflammatory


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)