Eczema Soothing Moisturizing Cream
FDA Label NDC 11344-965

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Nice-pak Products, Llc for the product Eczema Soothing Moisturizing Cream (NDC 11344-965). 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 if, keep out of reach of children., directions, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Active Ingredient

Colloidal oatmeal 1%

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

  • 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 withing 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

Inactive Ingredients

water, glycerin, distearyldimonium chloride, petrolatum, isopropyl palmitate, cetyl alcohol, pathenol, dimethicone, Avena sativa (oat) kernel oil, steareth-20, Avena sativa (oat) kernel extract, benzalkonium chloride, ceramide NP, sodium chloride, benzyl alcohol, sodium hydroxide

Disclaimer

*This product is not manufactured or distributed by Johnson & Johnson Consumer Products Company, distributor of Aveeno ®Eczema Therapy Moisturizing Cream.

Adverse Reaction

Distributed by:

Vi-Jon, LLC,

8515 Page Ave.,

St. Louis, MO 63114

Principal Panel Display

Swan ®

ECZEMA SOOTHING MOISTURIZING CREAM

colloidal oatmeal

skin protectant

  • Sooths dry skin, itchy, irritated skin from eczema
  • Steroid-free
  • Dermatologist tested
  • Fragrance free
  • Compare to Aveeno ® Eczema Therapy Moisturizing Cream*

    NET WT 7.3 OZ (207 g)

    Image Description (Mm01)

    Image Description (Mm01)

* Please review the disclaimer below.