Drug Facts

Drug Facts
SPL v2
SPL
SPL Set ID e555de17-9b42-4125-a17b-467bc1d179d7
Route
TOPICAL
Published
Effective Date 2023-12-11
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Oatmeal (10 mg)
Inactive Ingredients
Water Shea Butter Glycerin Dimethicone Mineral Oil Niacinamide Cetostearyl Alcohol Canola Oil Peg-100 Stearate Glyceryl Monostearate Tocopherol Sodium Benzoate Peg-20 Methyl Glucose Sesquistearate Dimethiconol (100000 Cst) Mannose, D- Xanthan Gum Pentaerythritol Tetrakis(3-(3,5-di-tert-butyl-4-hydroxyphenyl)propionate) Capryloyl Glycine Microcrystalline Wax Sorbitan Tristearate Paraffin Edetate Disodium Citric Acid Monohydrate

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Completed Since 2017-11-21 Until 2017-11-21

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, shea butter, glycerin, dimethicone, mineral oil, niacinamide, cetearyl alcohol, rapeseed seed oil, ammonium polyacryloyldimethyl taurate, PEG-100 stearate, glyceryl stearate, tocopherol, sodium benzoate, PEG-20 methyl glucose sesquistearate, dimethiconol, mannose, xanthan gum, pentaerythrityl tetra-di-t-butyl hydroxyhydrocinnamate, capryloyl glycine, microcrystalline wax, sorbitan tristearate, paraffin, discodium EDTA, vitreoscilla ferment, citric acid

Questions Or Comments?

1-888-LRP LABO

1-888-577-5226

Monday - Friday (9 a.m. - 5 p.m. EST)

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, shea butter, glycerin, dimethicone, mineral oil, niacinamide, cetearyl alcohol, rapeseed seed oil, ammonium polyacryloyldimethyl taurate, PEG-100 stearate, glyceryl stearate, tocopherol, sodium benzoate, PEG-20 methyl glucose sesquistearate, dimethiconol, mannose, xanthan gum, pentaerythrityl tetra-di-t-butyl hydroxyhydrocinnamate, capryloyl glycine, microcrystalline wax, sorbitan tristearate, paraffin, discodium EDTA, vitreoscilla ferment, citric acid

Questions Or Comments? (Questions or comments?)

1-888-LRP LABO

1-888-577-5226

Monday - Friday (9 a.m. - 5 p.m. EST)

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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