Active Ingredient
Colloidal oatmeal 1%
Avene Xeracalm Eczema Calming Relief Balm Cream
FDA Label NDC 64760-777
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Pierre Fabre Usa Inc. for the product Avene Xeracalm Eczema Calming Relief Balm (NDC 64760-777). 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 active ingredient, purpose, uses, warnings, when using this product, stop use and ask a doctor, keep out of reach of children., directions, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Skin protectant
Uses
Temporarily protects and helps relieve minor skin irritation and itching due to:
- Eczema
- Rashes
Warnings
For external use only.
When Using This Product
When using this product - do not get into eyes
Stop Use And Ask A Doctor
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.
Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.
Directions
- Apply as needed. For targeted areas on body, face and hands.
Inactive Ingredients
Water (aqua), Propanediol, Caprylic/capric triglyceride, Glyceryl stearate, Cetearyl alcohol, Cetyl alcohol, Glycerin, 1,2 Hexanediol, Arginine, Caprylyl glycol, Ceramide NP, Citric acid, Maltodextrin, Oenothera biennis (evening primrose) oil, Ophiopogon japonicus root extract, Polyacrylate-13, Polyisobutene, Polysorbate 20, Sodium benzoate, Sodium hydroxide, Sorbitan isostearate, Tocopherol.
Questions?
1-866-41-AVENE (28363).
* Please review the disclaimer below.
