FDA.reportPublic FDA data

Kids Eczema Cream 2 oz

Manufacturer
Rosemont Ventures, Inc. | Monarch PCM, LLC
Effective date
2022-09-21
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
legacy-cache
Hydrated at
2026-08-01 21:52:54

Label at a glance#

ProductKids Eczema
Active ingredientOATMEAL
Label structure8 sections

Indications and uses

Temporarily protects and helps relieve minor skin irritation and itching due to: rashes eczema

Dosage and administration

Apply as needed

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Colloidal Oatmeal 1.0%

Purpose

OTC - PURPOSE SECTION

Colloidal Oatmeal 1.0%..................Skin Protectant

Uses

INDICATIONS & USAGE SECTION

Temporarily protects and helps relieve minor skin irritation and itching due to:

  • rashes
  • 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

  • condition worsens
  • 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 as needed

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Allantoin, Aloe Barbadensis (Aloe) Leaf Extract, Aqua (Water), Azadirachta Indica (Neem) Seed Oil, Bisabolol, Butyrospermum Parkii (Shea) Butter, Calcium Gluconate, Caprylic/Capric Triglyceride, Citric Acid, Eucalyptus Globulus (Eucalyptus) Leaf Oil, Gluconolactone, Glycerin, Glyceryl Stearate SE, Kaolin, Potassium Sorbate, Sodium Benzoate, Squalane, Stearyl Alcohol, Xanthan Gum, Zea Mays (Corn) Starch†, Zinc Oxide

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Effective, natural & safe

ALL TERRAIN

Kids Eczema Cream

Colloidal Oatmeal 1% Skin Protectant

Soothes, protects & relieves itching & irritation due to eczema

Made with 95+% naturally derived ingredients

2.0 FL. OZ. (59 mL)

11

22

Products#

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

DailyMed product names page 1 of 1 · 24 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
82960-24582960-245-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 22 matching rows.

Name, UNII, Kind table
NameUNIIKind
WATER059QF0KO0RIACT
SQUALANEGW89575KF9IACT
STARCH, CORNO8232NY3SJIACT
ALOE VERA LEAFZY81Z83H0XIACT
OATMEAL8PI54V663YACTIB
ALLANTOIN344S277G0ZIACT
AZADIRACHTA INDICA SEED OIL4DKJ9B3K2TIACT
LEVOMENOL24WE03BX2TIACT
SODIUM BENZOATEOJ245FE5EUIACT
SHEA BUTTERK49155WL9YIACT
CALCIUM GLUCONATESQE6VB453KIACT
EUCALYPTUS GLOBULUS LEAFS546YLW6E6IACT
GLUCONOLACTONEWQ29KQ9POTIACT
GLYCERYL STEARATE SEFCZ5MH785IIACT
STEARYL ALCOHOL2KR89I4H1YIACT
XANTHAN GUMTTV12P4NEEIACT
ZINC OXIDESOI2LOH54ZIACT
POTASSIUM SORBATE1VPU26JZZ4IACT
MEDIUM-CHAIN TRIGLYCERIDESC9H2L21V7UIACT
CITRIC ACID MONOHYDRATE2968PHW8QPIACT
GLYCERINPDC6A3C0OXIACT
KAOLIN24H4NWX5COIACT

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
0d9a8769-874d-c4d8-e063-6394a90a6e10e932aa34-c460-b6ed-e053-2a95a90a2b3a2023-12-28WarningsExact identifier
spl set id: e932aa34-c460-b6ed-e053-2a95a90a2b3a

Reported adverse events (FAERS/openFDA)#

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