Baby Eczema Moisturizing
FDA Label NDC 63940-429

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Harmon Stores Inc. for the product Baby Eczema Moisturizing (NDC 63940-429). 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.

Label Section Quick Index

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 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

Inactive Ingredients

water, glycerin, distearyldimonium chloride, isopropyl palmitate, cetearyl alcohol, petrolatum, avena sativa (oat) kernel flour, dimethicone, steareth-21, panthenol (pro-vitamin B5), benzalkonium chloride, sodium chloride, ceramide 3, ceramide 6-II, ceramide 1, phytosphingosine, cholesterol, sodium lauroyl lactylate, carbomer, xanthan gum, sativa (oat) kernel oil, avena sativa (oat) kernel extract, triethanolamine.

Package/Label Principal Display Panel

buybuy
BABY™
eczema
MOISTURIZING
CREAM

colloidal oatmeal
skin protectant

Helps relieve dry, itchy
and irritated skin

Helps sooth eczema
related skin conditions

Steroid-free

Fragrance-free

DERMATOLOGIST
TESTED

NET WT 5 OZ (140 g)

baby eczema
moisturizing cream

Enriched with soothing oatmeal, this innovative cream offers relief to help care
for dry, itchy skin, while intensely moisturizing it. It helps to fortify your baby’s
skin's natural barrier functions while helping to prevent the recurrence of dry
skin. Our formula is enriched with ceramides, essential lipids naturally found in
the skin, to enhance and restore the baby’s skin's natural protective function.

MADE EXPRESSLY FOR
buybuy BABY™
650 Liberty Avenue,
Union, NJ 07083
© BUY BUY BABY INC.
WWW.BUYBUYBABY.COM
MADE IN ISRAEL

Carton Label (Image 01)

Carton Label (Image 01)

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