drug facts

drug facts
SPL v1
SPL
SPL Set ID 4138eb24-bef2-49df-ad9c-ab6c5d381baa
Route
topical
Published
Effective Date 2017-11-29
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
oatmeal (0.01 g)
Inactive Ingredients
water glycerin distearyldimonium chloride petrolatum isopropyl palmitate cetyl alcohol panthenol dimethicone oat steareth-20 oat kernel oil benzalkonium chloride isocetyl alcohol ceramide np sodium chloride

Identifiers & Packaging

Marketing Status
otc monograph final active Since 2017-11-28
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
  • apply as needed or as directed by a physician.
Other Information
  • store at room temperature
Inactive Ingredients

Water (Aqua), Glycerin, Distearyldimonium Chloride, Petrolatum, Isopropyl Palmitate, Cetyl Alcohol, Panthenol, 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%

Questions Or Comments?

1-800-925-4733

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

Label Copy

Active Ingredient (Active ingredient)

Colloidal Oatmeal 1%

Questions Or Comments? (Questions or comments?)

1-800-925-4733

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

Back to search View SPL set listing Open on DailyMed ↗

Source: dailymed · Ingested: 2026-02-15T11:56:26.730046 · Updated: 2026-03-14T22:54:55.117494