FDA.reportPublic FDA data

Glad Skin

Manufacturer
Prime Enterprises | Prime Enterprise
Effective date
2020-08-26
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
legacy-cache
Hydrated at
2026-08-01 23:17:00

Label at a glance#

ProductGlad Skin Eczema Cream
Active ingredientOATMEAL
Label structure10 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.

When using this product do not get into eyes.

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.

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, Tromethamine, Calcium Chloride, sr-(Methionyl Staphylococcus Simulans Polypeptide-1 Dipeptide-53 Staphylococcus Phage 2638A Polypeptide-1)​

Other Information

OTHER SAFETY INFORMATION

Store at 33°F-75°F

Questions

OTC - QUESTIONS SECTION

Support@gladskin.com

Keep out of reach of children

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. ​

Package Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Principal Display LabelPrincipal 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
58443-034158443-0341-2

Ingredients#

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

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

Name, UNII, Kind table
NameUNIIKind
PETROLATUM4T6H12BN9UIACT
GLYCERINPDC6A3C0OXIACT
MINERAL OILT5L8T28FGPIACT
POLYOXYL 20 CETOSTEARYL ETHERYRC528SWUYIACT
TROMETHAMINE023C2WHX2VIACT
ARGININE HYDROCHLORIDEF7LTH1E20YIACT
SODIUM CHLORIDE451W47IQ8XIACT
CETOSTEARYL ALCOHOL2DMT128M1SIACT
WATER059QF0KO0RIACT
CALCIUM CHLORIDEM4I0D6VV5MIACT
OATMEAL8PI54V663YACTIB

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
adcd123d-edb6-0bc1-e053-2a95a90a5085a8718c36-59a2-5616-e053-2995a90a606b2020-08-26WarningsExact identifier
spl id: adcd123d-edb6-0bc1-e053-2a95a90a5085
spl set id: a8718c36-59a2-5616-e053-2995a90a606b

Reported adverse events (FAERS/openFDA)#

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