Gentle Eczema Balm

Manufacturer: Naterra International INC. | Beautymanufacturing Solutions Corperation
Effective date: 2011-10-12
Label type: HUMAN OTC DRUG LABEL
Version: 1
Source: full-release
Hydrated at: 2026-05-31 22:29:48

Label at a glance#

ProductGentle Eczema Balm

Active ingredientOatmeal

Label structure7 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Active Ingredient: Colloid Oatmeal USP (0.8%)

OTC - PURPOSE SECTION

Purpose : Skin Protectant

WARNINGS SECTION

Warnings: For external use only

Stop use and ask doctor if * condition worsens, * symptoms last more than 7 days or clear up and occur again within a few days.

INDICATIONS & USAGE SECTION

Uses :

* Temporary protects and helps relieve minor skin irritation and itching due to * eczema

DOSAGE & ADMINISTRATION SECTION

Direction ; Apply as needed

INACTIVE INGREDIENT SECTION

Fragrance

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Image of Label

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	SPL version
1190939	colloidal oatmeal 0.8 % Topical Stick	PSN	1
1190939	colloidal oatmeal 0.008 MG/MG Topical Ointment	SCD	1
1190939	colloidal oatmeal 0.112 GM in 14 GM Topical Stick	SY	1
1190939	colloidal oatmeal 0.8 % Topical Stick	SY	1

DailyMed Pharmacologic Classes#

Class, Version, Type table
Class	Version	Type	Effective
OATMEAL Pharmacologic Class Indexing	2	Indexing - Pharmacologic Class	20181113

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
45765-5142-0	2019-11-13	C162847	48780-1	97449f38-bc54-f6ea-e053-dbdaa90aa703	eb169720-9cdb-4649-917f-3c44c0d16db2

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
45765-5142-0	Gentle Eczema Balm	14 g in 1 CASE	STICK	14		1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
45765-5142	GENTLE ECZEMA BALM (COLLOID OATMEAL) STICK [NATERRA INTERNATIONAL INC.]	1	Legacy NDC, 1 package rows	20111020_eb169720-9cdb-4649-917f-3c44c0d16db2.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	SPL version
Oatmeal	ACTIVE INGREDIENT	8PI54V663Y	1
Oatmeal	ACTIVE MOIETY	8PI54V663Y	1
CERESIN	INACTIVE INGREDIENT	Q1LS2UJO3A	1
ISOPROPYL PALMITATE	INACTIVE INGREDIENT	8CRQ2TH63M	1
MICROCRYSTALLINE WAX	INACTIVE INGREDIENT	XOF597Q3KY	1
SAFFLOWER OIL	INACTIVE INGREDIENT	65UEH262IS	1
SHEA BUTTER	INACTIVE INGREDIENT	K49155WL9Y	1

Products#

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

DailyMed product names page 1 of 1 · 8 matching rows.

Gentle Eczema Balm
Colloid Oatmeal
Oatmeal
SHEA BUTTER
ISOPROPYL PALMITATE
SAFFLOWER OIL
CERESIN
MICROCRYSTALLINE WAX

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
45765-5142	45765-5142-0

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 6 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
Oatmeal	8PI54V663Y	ACTIB
SHEA BUTTER	K49155WL9Y	IACT
ISOPROPYL PALMITATE	8CRQ2TH63M	IACT
SAFFLOWER OIL	65UEH262IS	IACT
CERESIN	Q1LS2UJO3A	IACT
MICROCRYSTALLINE WAX	XOF597Q3KY	IACT

Source Document#

Source XML

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 1 · 16 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredient	IID ingredient	UNII	Dosage form / route	Potency	Maximum daily exposure	Match
ISOPROPYL PALMITATE	ISOPROPYL PALMITATE	8CRQ2TH63M	FILM, EXTENDED RELEASE / TRANSDERMAL	187.5 mg		Exact identifier — unii candidate 8 equally ranked IID candidates
ISOPROPYL PALMITATE	ISOPROPYL PALMITATE	8CRQ2TH63M	GEL / TOPICAL	NA		Exact identifier — unii candidate 8 equally ranked IID candidates
CERESIN	CERESIN	Q1LS2UJO3A	OINTMENT / TOPICAL		1097 mg	Exact identifier — unii candidate 2 equally ranked IID candidates
ISOPROPYL PALMITATE	ISOPROPYL PALMITATE	8CRQ2TH63M	FILM / TRANSDERMAL		2 mg	Exact identifier — unii candidate 8 equally ranked IID candidates
MICROCRYSTALLINE WAX	MICROCRYSTALLINE WAX	XOF597Q3KY	OINTMENT / TOPICAL		3575 mg	Exact identifier — unii candidate 4 equally ranked IID candidates
SAFFLOWER OIL	SAFFLOWER OIL	65UEH262IS	LOTION / TOPICAL		3510 mg	Exact identifier — unii candidate
ISOPROPYL PALMITATE	ISOPROPYL PALMITATE	8CRQ2TH63M	LOTION / TOPICAL	5 %w/w		Exact identifier — unii candidate 8 equally ranked IID candidates
ISOPROPYL PALMITATE	ISOPROPYL PALMITATE	8CRQ2TH63M	CREAM / TOPICAL		112 mg	Exact identifier — unii candidate 8 equally ranked IID candidates
ISOPROPYL PALMITATE	ISOPROPYL PALMITATE	8CRQ2TH63M	AEROSOL, SPRAY / TOPICAL		397 mg	Exact identifier — unii candidate 8 equally ranked IID candidates
MICROCRYSTALLINE WAX	MICROCRYSTALLINE WAX	XOF597Q3KY	GEL / TOPICAL	NA		Exact identifier — unii candidate 4 equally ranked IID candidates
ISOPROPYL PALMITATE	ISOPROPYL PALMITATE	8CRQ2TH63M	OINTMENT / TOPICAL	NA		Exact identifier — unii candidate 8 equally ranked IID candidates
CERESIN	CERESIN	Q1LS2UJO3A	CREAM / VAGINAL		280 mg	Exact identifier — unii candidate 2 equally ranked IID candidates
ISOPROPYL PALMITATE	ISOPROPYL PALMITATE	8CRQ2TH63M	AEROSOL / TOPICAL		397 mg	Exact identifier — unii candidate 8 equally ranked IID candidates
MICROCRYSTALLINE WAX	MICROCRYSTALLINE WAX	XOF597Q3KY	CAPSULE, EXTENDED RELEASE / ORAL	6 mg		Exact identifier — unii candidate 4 equally ranked IID candidates
MICROCRYSTALLINE WAX	MICROCRYSTALLINE WAX	XOF597Q3KY	CREAM / VAGINAL		23 mg	Exact identifier — unii candidate 4 equally ranked IID candidates
SHEA BUTTER	SHEA BUTTER	K49155WL9Y	LOTION / TOPICAL		2340 mg	Exact identifier — unii candidate

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
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
7eb7f345-33c5-41d7-bc5d-c3d2e8b3ce77			eb169720-9cdb-4649-917f-3c44c0d16db2	2011-10-12	Warnings	Exact identifier spl id: 7eb7f345-33c5-41d7-bc5d-c3d2e8b3ce77 spl set id: eb169720-9cdb-4649-917f-3c44c0d16db2

Reported adverse events (FAERS/openFDA)#

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