Colloidal Oatmeal Cream
FDA Label NDC 37808-128

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by H E B for the product Colloidal Oatmeal (NDC 37808-128). 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

Other Information

store at room temperature

Inactive Ingredients

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

Adverse Reactions

We hope you are satisfied with this product.  If not, we will cheerfully refund your money.

DISTRIBUTED BY: H-E-B, SAN ANTONIO, TN 78204N-NMADE IN THE USA WTH U.S. AND FOREIGN COMPONENTS - LOT NUMBER: ON PACKAGE - QUESTIONS? 1-888-593-0593

Principal Display Panel

HILL COUNTRY

ESSENTIALS

Baby Eczema

Therapy Cream

COLLOIDAL OATMEAL

SKIN PROTECTANT

FREE FROM

parabens - phthalates - dyes

NET WT. 5 OZ

CONT.NET. 141 g

Image Description (Mm3)

Image Description (Mm3)

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