drug facts

drug facts
SPL v5
SPL
SPL Set ID 22e088b9-b3b1-4c34-be12-a5a31200ec25
Route
topical
Published
Effective Date 2025-06-30
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
oatmeal (10 mg)
Inactive Ingredients
water glycerin caprylic/capric triglyceride squalane butyrospermum parkii (shea) butter stearyl alcohol cetyl alcohol myristyl myristate c15-19 alkane phenoxyethanol panthenol glyceryl stearate dimethicone peg-100 stearate persea gratissima (avocado) oil chlorphenesin stearic acid palmitic acid trisodium ethylenediamine disuccinate carbomer acrylates/c10-30 alkyl acrylate crosspolymer (60000 mpa.s) tocopherol bisabolol zinc gluconate soybean oil pentaerythrityl tetra-di-t-butyl hydroxyhydrocinnamate xanthan gum ethylhexylglycerin adenosine sodium hydroxide myristic acid citric acid helianthus annuus (sunflower) seed oil rosemary

Identifiers & Packaging

Marketing Status
otc monograph drug active Since 2025-11-15

Purpose

Skin protectant

Description

Colloidal oatmeal 1%


Medication Information

Warnings

For external use only

Uses

temporarily protects and helps relieve minor skin irritation and itching due to:

  • rashes
  • eczema
  • poison ivy, oak, or sumac
  • insect bites
Purpose

Skin protectant

Directions

apply as needed

Inactive Ingredients

Water, glycerin, caprylic/capric triglyceride, squalane, butyrospermum parkii (shea) butter, stearyl alcohol, cetyl alcohol, myristyl myristate, C15-19 alkane, phenoxyethanol, panthenol, glyceryl stearate, dimethicone, PEG-100 stearate, persea gratissima (avocado) oil, chlorphenesin, stearic acid, palmitic acid, trisodium ethylenediamine disuccinate, carbomer, acrylates/C10-30 alkyl acrylate crosspolymer, tocopherol, bisabolol, zinc gluconate, glycine soja (soybean) oil, pentaerythrityl tetra-di-t-butyl hydroxyhydrocinnamate, xanthan gum, ethylhexylglycerin, adenosine, sodium hydroxide, myristic acid, citric acid, helianthus annuus (sunflower) seed oil, rosmarinus officinalis (rosemary) leaf extract

Description

Colloidal oatmeal 1%

Section 51945-4

Active Ingredient

Colloidal oatmeal 1%

Questions Or Comments?

Call toll free 1-800-946-4453

When Using This Product

do not get into eyes

Stop Use and Ask A Doctor If

• condition worsens

• symptoms last more than 7days 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

Warnings

For external use only

Uses

temporarily protects and helps relieve minor skin irritation and itching due to:

  • rashes
  • eczema
  • poison ivy, oak, or sumac
  • insect bites
Purpose

Skin protectant

Directions

apply as needed

Inactive Ingredients (Inactive ingredients)

Water, glycerin, caprylic/capric triglyceride, squalane, butyrospermum parkii (shea) butter, stearyl alcohol, cetyl alcohol, myristyl myristate, C15-19 alkane, phenoxyethanol, panthenol, glyceryl stearate, dimethicone, PEG-100 stearate, persea gratissima (avocado) oil, chlorphenesin, stearic acid, palmitic acid, trisodium ethylenediamine disuccinate, carbomer, acrylates/C10-30 alkyl acrylate crosspolymer, tocopherol, bisabolol, zinc gluconate, glycine soja (soybean) oil, pentaerythrityl tetra-di-t-butyl hydroxyhydrocinnamate, xanthan gum, ethylhexylglycerin, adenosine, sodium hydroxide, myristic acid, citric acid, helianthus annuus (sunflower) seed oil, rosmarinus officinalis (rosemary) leaf extract

Section 51945-4 (51945-4)

Active Ingredient (Active ingredient)

Colloidal oatmeal 1%

Questions Or Comments? (Questions or comments?)

Call toll free 1-800-946-4453

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 7days 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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