GLADSKIN ECZEMA- colloidal oatmeal cream

Manufacturer
Prime Enterprises | Prime Enterprise
Effective date
2022-04-21
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
legacy-cache
Hydrated at
2026-08-01 22:02:45

Label at a glance#

ProductGlad Skin Eczema Cream
Active ingredientOATMEAL
Label structure7 sections

Indications and uses

Temporarily protects and helps relieve minor skin iritation and itching due to eczema.

Dosage and administration

Apply twice daily, or more as desired, on skin free of other products. Let the cream absorb into skin for 5 minutes before applying other products.

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Colloidal Oatmeal 0.02%

Purpose

OTC - PURPOSE SECTION

Skin Protectant

Uses

INDICATIONS & USAGE SECTION

Temporarily protects and helps relieve minor skin iritation and itching due to eczema.

Warnings

WARNINGS SECTION

For external use only.

OTC - WHEN USING SECTION

When using this product do not get into eyes.

OTC - STOP USE SECTION

Stop use and ask a doctor if:

  • Conditions worsen
  • Symptoms last more than 7 days or clear up and occur again within a few days.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. If swallowed, get medical help or contact a poison control center right away. ​

Directions

DOSAGE & ADMINISTRATION SECTION

  • Apply twice daily, or more as desired, on skin free of other products.
  • Let the cream absorb into skin for 5 minutes before applying other products.

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Water, Glycerin, Petrolatum, Mineral Oil, Cetearyl Alcohol, Ceteareth-20, Arginine HCl, Sodium Chloride, Trometamol, Calcium Chloride, sr-(Methionyl Staphylococcus Simulans Polypeptide-1 Dipeptide-53 Staphylococcus Phage 2638A Polypeptide-1)​

Questions

OTC - QUESTIONS SECTION

hello@gladskin.com

Principle Display Label - Gladskin Eczema Cream 50 mL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Principle Display LabelPrinciple Display Label

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 13 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
58443-054858443-0548-3

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 11 matching rows.

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
dd2c44c3-9355-2d00-e053-2a95a90ad08da6a20e35-bedc-b2f3-e053-2995a90ac1682022-04-21WarningsExact identifier
spl id: dd2c44c3-9355-2d00-e053-2a95a90ad08d
spl set id: a6a20e35-bedc-b2f3-e053-2995a90ac168

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.