drug facts

drug facts
SPL v1
SPL
SPL Set ID 0e433bbc-dbf9-4393-826c-4a91a8b8e138
Route
topical
Published
Effective Date 2019-02-01
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
oatmeal (10 mg)
Inactive Ingredients
water glycerin distearyldimonium chloride panthenol petrolatum isopropyl palmitate cetyl alcohol dimethicone oat kernel oil steareth-20 benzalkonium chloride isocetyl alcohol ceramide np sodium chloride

Identifiers & Packaging

Marketing Status
otc monograph final active Since 2019-01-30
Purpose

Skin protectant

Description

Colloidal Oatmeal 1%

Medication Information

Warnings

For external use only

Uses
  • Temporarily protects and helps relieve minor skin itching and irritation due to eczema.
Purpose

Skin protectant

Directions
  • For mild to moderate eczema only, apply as needed or as directed by a physician.
Other Information
  • Store at room temperature.
Inactive Ingredients

Water (Aqua), Glycerin, Distearyldimonium Chloride, Panthenol, Petrolatum, Isopropyl Palmitate, Cetyl Alcohol, Dimethicone, Avena Sativa (Oat) Kernel Oil, Steareth-20, Avena Sativa (Oat) Kernel Extract, Benzalkonium Chloride, Isocetyl Alcohol, Ceramide NP, Sodium Chloride.

Description

Colloidal Oatmeal 1%

Label Copy

Active Ingredient

Colloidal Oatmeal 1%

When Using This Product
  • avoid contact with eyes.
  • if contact occurs, rinse thoroughly with water.
Keep Out of Reach of Children.
  • In case of accidental ingestion, get medical help or contact a Poison Control Center immediately.

Stop Using This Product and Ask A Doctor If
  • condition worsens, or if symptoms last more than 7 days, or if they clear up and occur again within a few days.

Structured Label Content

Warnings

For external use only

Uses
  • Temporarily protects and helps relieve minor skin itching and irritation due to eczema.
Purpose

Skin protectant

Directions
  • For mild to moderate eczema only, apply as needed or as directed by a physician.
Other Information (Other information)
  • Store at room temperature.
Inactive Ingredients (Inactive ingredients)

Water (Aqua), Glycerin, Distearyldimonium Chloride, Panthenol, Petrolatum, Isopropyl Palmitate, Cetyl Alcohol, Dimethicone, Avena Sativa (Oat) Kernel Oil, Steareth-20, Avena Sativa (Oat) Kernel Extract, Benzalkonium Chloride, Isocetyl Alcohol, Ceramide NP, Sodium Chloride.

Label Copy (Label copy)

Active Ingredient (Active ingredient)

Colloidal Oatmeal 1%

When Using This Product (When using this product)
  • avoid contact with eyes.
  • if contact occurs, rinse thoroughly with water.
Keep Out of Reach of Children. (Keep out of reach of children.)
  • In case of accidental ingestion, get medical help or contact a Poison Control Center immediately.

Stop Using This Product and Ask A Doctor If (Stop using this product and ask a doctor if)
  • condition worsens, or if symptoms last more than 7 days, or if they clear up and occur again within a few days.

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T11:56:44.790234 · Updated: 2026-03-14T22:55:25.290849