Babyspa Calming Relief Eczema
FDA Label NDC 42957-002

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Expro3, Llc for the product Babyspa Calming Relief Eczema (NDC 42957-002). 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, package label.principal display panel, 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

Colloidal Oatmeal 0.1%............Skin Protectant

Otc - Purpose

Intensively Hydrates & Naturally Helps to Relieve Dry, Itchy, Irritated Skin due to Eczema & Rashes

Otc - Keep Out Of Reach Of Children

Keep out of the reach of children

Indications & Usage

Uses:

Temporarily protects and helps relieve 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

      • If swallowed, get medical help or contact a Poison Control Center right away. (U.S. - 1-800-222-1222)

Dosage & Administration

Directions:

  • Apply liberally to dry, itchy patches and irritated skin, as often as necessary.
  • Suitable for daily use.
  • Delicate enough to use on newborn skin.

    • Other Information:

    For use on mild to moderate excema or as directed by a physician. Store at room temperature.

Inactive Ingredient

Inactive Ingredients:

water (aqua), vegetable glycerin, caprylic/capric/triglyceride, simmondsia chinensis (jojoba) seed oil*, butyrospermum parkii (shea butter), cetyl alcohol, aloe vera barbadensis leaf juice*, symphytum officinale leaf extract, phenoxyethanol, xanthan gum, caprylyl glycol, calendula officinalis flower oil, avena sativa (oat) kernel extract, bisabolol, anthemis nobilis (chamomile) flower extract*.

*certified organic

* Please review the disclaimer below.