Xerbex Eczema Cream
FDA Label NDC 81021-011

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Xerbal Usa Llc for the product Xerbex Eczema Cream (NDC 81021-011). 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 other, otc - purpose, uses, warnings, do not use, when using this product, stop use and ask a doctor if, otc - 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

Other

Drug Facts

Otc - Purpose

Active IngredientsPurpose
Colloidal Oatmeal 1%   Skin Protectant

Uses

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

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

Warnings

For external use only

Do Not Use

  • if allergic to any ingredients of this product

When Using This Product

  • do not get into eyes

Stop Use And Ask A Doctor If

  • condition worsens
  • symptoms last more than 7 days
  • symptoms clear up and occur again within a few days
  • excessive irritation of the skin develops
  • side effects occur. You may report side effects to FDA at 1–800–FDA–1088.

Otc - Keep Out Of Reach Of Children

Keep out of reach of children to avoid accidental poisoning .

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

Directions

  • Apply as needed

Other Information

  • store at room temperature, 20 to 25 oC(68 to 77 oF)

Questions?

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1-626-822-8211

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