Drug Facts

Drug Facts
SPL v1
SPL
SPL Set ID c4dde987-fe4e-4f8e-8f3a-1bc12c9588ed
Route
TOPICAL
Published
Effective Date 2025-12-09
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Oatmeal (10 mg)
Inactive Ingredients
Water Butyrospermum Parkii (shea) Butter Glycerin Dimethicone Cetearyl Alcohol Niacinamide Caprylic/capric Triglyceride Glyceryl Stearate Peg-100 Stearate Ammonium Polyacryloyldimethyl Taurate Ceramide Np Ceramide Ap Sorbitan Tristearate Carbomer Cetearyl Isononanoate Behentrimonium Methosulfate Triethyl Citrate Sodium Benzoate Sodium Lauroyl Lactylate Sodium Hyaluronate Cholesterol Phenoxyethanol Tocopherol Citric Acid Caprylyl Glycol Trisodium Ethylenediamine Disuccinate Xanthan Gum Pentaerythrityl Tetra-di-t-butyl Hydroxyhydrocinnamate Phytosphingosine Octyldodecanol Benzoic Acid Peg-20 Methyl Glucose Sesquistearate

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-12-01

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: •eczema •rashes
Section 51945-4

Warnings

For external use only

Directions

apply as needed

Active Ingredient

Colloidal oatmeal 1%

Inactive Ingredients

water, butyrospermum parkii (shea) butter, glycerin, dimethicone, cetearyl

alcohol, niacinamide, caprylic/capric triglyceride, glyceryl stearate,

PEG-100 stearate, ammonium polyacryloyldimethyl taurate, ceramide NP,

ceramide AP, ceramide EOP, sorbitan tristearate, carbomer, cetearyl

isononanoate, behentrimonium methosulfate, triethyl citrate, sodium

benzoate, sodium lauroyl lactylate, sodium hyaluronate, cholesterol,

phenoxyethanol, tocopherol, citric acid, caprylyl glycol, trisodium

ethylenediamine disuccinate, xanthan gum, pentaerythrityl tetra-di-t-butyl

hydroxyhydrocinnamate, phytosphingosine, octyldodecanol, benzoic acid,

PEG-20 methyl glucose sesquistearate

Questions Or Comments?

Toll-free number 1-888-768-2915

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

Active Ingredient (Active ingredient)

Colloidal oatmeal 1%

Inactive Ingredients (Inactive ingredients)

water, butyrospermum parkii (shea) butter, glycerin, dimethicone, cetearyl

alcohol, niacinamide, caprylic/capric triglyceride, glyceryl stearate,

PEG-100 stearate, ammonium polyacryloyldimethyl taurate, ceramide NP,

ceramide AP, ceramide EOP, sorbitan tristearate, carbomer, cetearyl

isononanoate, behentrimonium methosulfate, triethyl citrate, sodium

benzoate, sodium lauroyl lactylate, sodium hyaluronate, cholesterol,

phenoxyethanol, tocopherol, citric acid, caprylyl glycol, trisodium

ethylenediamine disuccinate, xanthan gum, pentaerythrityl tetra-di-t-butyl

hydroxyhydrocinnamate, phytosphingosine, octyldodecanol, benzoic acid,

PEG-20 methyl glucose sesquistearate

Questions Or Comments? (Questions or comments?)

Toll-free number 1-888-768-2915

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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