Oatmeal
FDA Label NDC 33992-1129

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Greenbrier International for the product Oatmeal (NDC 33992-1129). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding otc - active ingredient, otc - purpose, otc - keep out of reach of children, indications & usage, warnings, dosage & administration, inactive ingredient, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Otc - Active Ingredient


Active Ingredient                                          Purpose

Dimethicone 0.15%                                      Skin Protectant


Otc - Purpose

Help prevent and temporarily protects chafed, chapped or cracked skin.Helps prevent and protect from the drying effects of wind and cold weather.

Otc - Keep Out Of Reach Of Children

If swallowed, get medical help or contact a Poison Control Center right away.

Indications & Usage

Apply as needed, and do not get into eyes.

Warnings

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.

Dosage & Administration

apply as needed

Inactive Ingredient

water, mineral oil, cetyl alcohol, glycerin, propylene glycol, methylparaben, propylparaben, DMDM hydantoin, steareth-30, ammonium polyacrylate,  C13-16 isoparaffin, glyceryl stearate, fragrance, avena sativa (oat) protein extract

* Please review the disclaimer below.