Theraplex Eczema Therapy Moisturizing Skin Protectant With Colloidal Oatmeal Cream
FDA Label NDC 82280-618

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Theraplex, Llc for the product Theraplex Eczema Therapy Moisturizing Skin Protectant With Colloidal Oatmeal (NDC 82280-618). 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 drug facts, active ingredient, purpose, uses, warnings, when using this product, stop use and ask a doctor if, keep out of reach of children., and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Drug Facts

Active Ingredient

Colloidal Oatmeal 1%

Purpose

Skin Protectant

Uses

temporarily protects and helps relive minor skin irritation and itching due to: • eczema • rashes

Warnings

For external use only

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.

Directions

apply as needed, or as directed by your doctor.

Other Information

  • store at room temperature
  • keep from freezing

Inactive Ingredients

cyclomethicone, ozokerite wax, petrolatum (special fraction)

Package Labeling:

Label3 (Label3)

Label3 (Label3)

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