FDA.reportPublic FDA data

Barrier Balm

Manufacturer
PROJECT CHEMISTRY, INC. | Packaging On Demand, Inc.
Effective date
2023-10-28
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 23:58:23

Label at a glance#

ProductBarrier Balm
Active ingredientZINC OXIDE
Label structure10 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Zinc Oxide 15%

OTC - PURPOSE SECTION

Skin Protectant

WARNINGS SECTION

Warnings:

For external use only.

OTC - WHEN USING SECTION

When using this product, avoid wounds and contact with eyes.

OTC - STOP USE SECTION

Stop use and ask a doctor if condition worsens or doesn't improve

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. In case of accidental ingestion, contact a physician or poison control center immediately.

DOSAGE & ADMINISTRATION SECTION

Directions:

Apply a thin layer as needed to clean, dry skin.

INACTIVE INGREDIENT SECTION

Inactive Ingredients Hydrogenated Soybean Oil, Coconut Alkanes, Silica, Hydrogenated Soy Polyglycerides, C15-23 Alkane, Madecassoside, Asiaticoside, Centella Asiatica Leaf Extract, Hippophae Rhamnoides Seed Oil, Moringa Oleifera Seed Oil, Coco-Caprylate, Tocopheryl Acetate, Menthol.

INDICATIONS & USAGE SECTION

To help prevent and relieve skin irritation from wetness.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

ILBB2ILBB2

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
245663zinc oxide 15 % Topical OintmentPSN2
245663zinc oxide 0.15 MG/MG Topical OintmentSCD2
245663zinc oxide 15 % Topical OintmentSY2
245663ZNO 0.15 MG/MG Topical OintmentSY2

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
75523-200-02Barrier Balm57 g in 1 TUBEOINTMENT572

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
75523-200BARRIER BALM (SKIN PROTECTANT) OINTMENT [PROJECT CHEMISTRY, INC.]2Legacy NDC, 1 package rows20231030_ea608b09-a043-7457-e053-2995a90a48af.zip

Products#

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

DailyMed product names page 1 of 1 · 15 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
75523-20075523-200-02

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 13 matching rows.

Name, UNII, Kind table
NameUNIIKind
MORINGA OLEIFERA SEED OILREM6A5QMC0IACT
CENTELLA ASIATICA LEAF6810070TYDIACT
COCO-CAPRYLATE/CAPRATE8D9H4QU99HIACT
C15-23 ALKANEJ3N6X3YK96IACT
ASIATICOSIDEPKO39VY215IACT
HIPPOPHAE RHAMNOIDES SEED OILT53SBG6741IACT
MENTHOLL7T10EIP3AIACT
HYDROGENATED SOYBEAN OILA2M91M918CIACT
ZINC OXIDESOI2LOH54ZACTIB
COCONUT ALKANES1E5KJY107TIACT
SILICON DIOXIDEETJ7Z6XBU4IACT
MADECASSOSIDECQ2F5O6YIYIACT
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0IACT

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
08c2eeef-4b80-4434-e063-6394a90afd14ea608b09-a043-7457-e053-2995a90a48af2023-10-28WarningsExact identifier
spl id: 08c2eeef-4b80-4434-e063-6394a90afd14
spl set id: ea608b09-a043-7457-e053-2995a90a48af

Reported adverse events (FAERS/openFDA)#

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