Drug Facts

Drug Facts
SPL v4
SPL
SPL Set ID bcf7b985-6875-4033-a412-1bb6d3afa6d8
Route
TOPICAL
Published
Effective Date 2024-01-01
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Oatmeal (10 mg)
Inactive Ingredients
Water Cetostearyl Alcohol Glycerin Cetyl Alcohol Polyoxyl 20 Cetostearyl Ether Olive Oil Isononyl Isononanoate Safflower Oil Peg-100 Stearate Monobasic Potassium Phosphate Allantoin Ceramide Np Ceramide Ap Ceramide 1 Carbomer Homopolymer, Unspecified Type Niacinamide Glyceryl Monostearate Soybean Oil Behentrimonium Methosulfate Grape Seed Oil Sodium Pyrrolidone Carboxylate Ophiopogon Japonicus Root Sodium Lauroyl Lactylate Sunflower Oil Cholesterol Rosemary Phenoxyethanol Chlorphenesin Dibasic Potassium Phosphate Tocopherol Propylheptyl Caprylate Hydroxyacetophenone Hyaluronic Acid Avocado Oil Xanthan Gum Phytosphingosine Ethylhexylglycerin

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2020-12-01

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, cetearyl alcohol, glycerin, cetyl alcohol, ceteareth-20, olea europaea (olive) fruit oil, isononyl isononanoate, carthamus tinctorius (safflower) seed oil, PEG-100 stearate, potassium phosphate, allantoin, ceramide NP, ceramide AP, ceramide EOP, carbomer, niacinamide, glyceryl stearate. glycine soja (soybean) oil, behentrimonium methosulfate, vitis vinifera (grape) seed oil, sodium PCA, ophiopogon japonicus root extract, sodium lauroyl lactylate, helianthus annuus (sunflower) seed oil, cholesterol, rosmarinus officinalis (rosemary) extract, rosmarinus officinalis (rosemary) leaf extract, phenoxyethanol, chlorphenesin, dipotassium phosphate, tocopherol, propylheptyl caprylate, hydroxyacetophenone, hydrolyzed hyaluronic acid, persea gratissima (avocado) oil, xanthan gum, phytosphingosine, ethylhexylglycerin

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, cetearyl alcohol, glycerin, cetyl alcohol, ceteareth-20, olea europaea (olive) fruit oil, isononyl isononanoate, carthamus tinctorius (safflower) seed oil, PEG-100 stearate, potassium phosphate, allantoin, ceramide NP, ceramide AP, ceramide EOP, carbomer, niacinamide, glyceryl stearate. glycine soja (soybean) oil, behentrimonium methosulfate, vitis vinifera (grape) seed oil, sodium PCA, ophiopogon japonicus root extract, sodium lauroyl lactylate, helianthus annuus (sunflower) seed oil, cholesterol, rosmarinus officinalis (rosemary) extract, rosmarinus officinalis (rosemary) leaf extract, phenoxyethanol, chlorphenesin, dipotassium phosphate, tocopherol, propylheptyl caprylate, hydroxyacetophenone, hydrolyzed hyaluronic acid, persea gratissima (avocado) oil, xanthan gum, phytosphingosine, ethylhexylglycerin

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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