Drug Facts

Drug Facts
SPL v5
SPL
SPL Set ID 22e088b9-b3b1-4c34-be12-a5a31200ec25
Route
TOPICAL
Published
Effective Date 2025-06-30
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Oatmeal (10 mg)
Inactive Ingredients
Water Glycerin Caprylic/capric Triglyceride Squalane Butyrospermum Parkii (shea) Butter Stearyl Alcohol Cetyl Alcohol Myristyl Myristate C15-19 Alkane Phenoxyethanol Panthenol Glyceryl Stearate Dimethicone Peg-100 Stearate Persea Gratissima (avocado) Oil Chlorphenesin Stearic Acid Palmitic Acid Trisodium Ethylenediamine Disuccinate Carbomer Acrylates/c10-30 Alkyl Acrylate Crosspolymer (60000 Mpa.s) Tocopherol Bisabolol Zinc Gluconate Soybean Oil Pentaerythrityl Tetra-di-t-butyl Hydroxyhydrocinnamate Xanthan Gum Ethylhexylglycerin Adenosine Sodium Hydroxide Myristic Acid Citric Acid Helianthus Annuus (sunflower) Seed Oil Rosemary

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-11-15

Description

Colloidal oatmeal 1%

Purpose

Skin protectant


Medication Information

Purpose

Skin protectant

Description

Colloidal oatmeal 1%

Uses

temporarily protects and helps relieve minor skin irritation and itching due to:

  • rashes
  • eczema
  • poison ivy, oak, or sumac
  • insect bites
Section 51945-4

Warnings

For external use only

Directions

apply as needed

Active Ingredient

Colloidal oatmeal 1%

Inactive Ingredients

Water, glycerin, caprylic/capric triglyceride, squalane, butyrospermum parkii (shea) butter, stearyl alcohol, cetyl alcohol, myristyl myristate, C15-19 alkane, phenoxyethanol, panthenol, glyceryl stearate, dimethicone, PEG-100 stearate, persea gratissima (avocado) oil, chlorphenesin, stearic acid, palmitic acid, trisodium ethylenediamine disuccinate, carbomer, acrylates/C10-30 alkyl acrylate crosspolymer, tocopherol, bisabolol, zinc gluconate, glycine soja (soybean) oil, pentaerythrityl tetra-di-t-butyl hydroxyhydrocinnamate, xanthan gum, ethylhexylglycerin, adenosine, sodium hydroxide, myristic acid, citric acid, helianthus annuus (sunflower) seed oil, rosmarinus officinalis (rosemary) leaf extract

Questions Or Comments?

Call toll free 1-800-946-4453

When Using This Product

do not get into eyes

Stop Use and Ask A Doctor If

• condition worsens

• symptoms last more than 7days 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:

  • rashes
  • eczema
  • poison ivy, oak, or sumac
  • insect bites
Section 51945-4 (51945-4)

Purpose

Skin protectant

Warnings

For external use only

Directions

apply as needed

Active Ingredient (Active ingredient)

Colloidal oatmeal 1%

Inactive Ingredients (Inactive ingredients)

Water, glycerin, caprylic/capric triglyceride, squalane, butyrospermum parkii (shea) butter, stearyl alcohol, cetyl alcohol, myristyl myristate, C15-19 alkane, phenoxyethanol, panthenol, glyceryl stearate, dimethicone, PEG-100 stearate, persea gratissima (avocado) oil, chlorphenesin, stearic acid, palmitic acid, trisodium ethylenediamine disuccinate, carbomer, acrylates/C10-30 alkyl acrylate crosspolymer, tocopherol, bisabolol, zinc gluconate, glycine soja (soybean) oil, pentaerythrityl tetra-di-t-butyl hydroxyhydrocinnamate, xanthan gum, ethylhexylglycerin, adenosine, sodium hydroxide, myristic acid, citric acid, helianthus annuus (sunflower) seed oil, rosmarinus officinalis (rosemary) leaf extract

Questions Or Comments? (Questions or comments?)

Call toll free 1-800-946-4453

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 7days 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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