Avedana ® Moisture Barrier Ointment (MBO)

Manufacturer: Unipack LLC
Effective date: 2024-02-13
Label type: HUMAN OTC DRUG LABEL
Version: 4
Source: full-release
Hydrated at: 2026-06-01 00:08:34

Label at a glance#

ProductMoisture Barrier

Active ingredientPETROLATUM

Label structure12 sections

Indications and uses

Temporarily protects minor cuts, scrapes, and burns Temporarily protects and helps relieve chapped or cracked skin Helps treat and prevent diaper rash caused from wetness, urine and/or stool

Dosage and administration

Gently cleanse and pat dry affected area Apply as needed

Storage and handling

Protect from freezing. Avoid excessive heat.

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Active Ingredient

White Petrolatum 98.3%

Purpose

OTC - PURPOSE SECTION

Skin Protectant

Uses

INDICATIONS & USAGE SECTION

Temporarily protects minor cuts, scrapes, and burns

Temporarily protects and helps relieve chapped or cracked skin

Helps treat and prevent diaper rash caused from wetness, urine and/or stool

Warnings

WARNINGS SECTION

For external use only

Do not use on

OTC - DO NOT USE SECTION

Do not use on - deep or puncture wounds - animal bites - serious burns - an area that is infected

When using this product

OTC - WHEN USING SECTION

When using this product - do not get into eyes

Stop use and ask a doctor if

OTC - ASK DOCTOR SECTION

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

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.

Directions

DOSAGE & ADMINISTRATION SECTION

Gently cleanse and pat dry affected area

Apply as needed

Inactive ingredients

INACTIVE INGREDIENT SECTION

aloe extract, benzethonium chloride, cholecalciferol (vitamin D), cococaprylate / caprate, corn oil, retinyl palmitate (vitamin A), tocopheryl acetate (vitamin E).

Other information

STORAGE AND HANDLING SECTION

Protect from freezing. Avoid excessive heat.

Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Label

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	SPL version
1090956	petrolatum 98.3 % Topical Ointment	PSN	4
1090956	petrolatum 0.983 MG/MG Topical Ointment	SCD	4
1090956	petrolatum 98.3 % Topical Ointment	SY	4

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
60c52429-fcef-eb54-2387-43bc9e4f296b	Product name	1	20140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
43749-231-02	2024-02-13	C162847	48780-1	1030e365-14eb-111a-e063-dadaa90a10e2	Avedana ® Moisture Barrier Ointment (MBO)
43749-231-02	2024-01-30	C162847	48780-1	1030e365-14eb-111a-e063-dadaa90a10e2	Avedana ® Moisture Barrier Ointment (MBO)

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
43749-231-02	Moisture Barrier	56 g in 1 TUBE	OINTMENT	56		4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
43749-231	MOISTURE BARRIER (MOISTURE BARRIER OINTMENT) OINTMENT [UNIPACK LLC]	4	Legacy NDC, 1 package rows	20240214_7a476687-d836-4775-9a8d-b9192b5955a0.zip

Products#

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

DailyMed product names page 1 of 1 · 10 matching rows.

Moisture Barrier
Moisture Barrier Ointment
COCO-CAPRYLATE/CAPRATE
BENZETHONIUM CHLORIDE
ALOE VERA LEAF
ALPHA-TOCOPHEROL ACETATE
CORN OIL
VITAMIN A PALMITATE
CHOLECALCIFEROL
PETROLATUM

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
43749-231	43749-231-02

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 8 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
COCO-CAPRYLATE/CAPRATE	8D9H4QU99H	IACT
BENZETHONIUM CHLORIDE	PH41D05744	IACT
ALOE VERA LEAF	ZY81Z83H0X	IACT
ALPHA-TOCOPHEROL ACETATE	9E8X80D2L0	IACT
CORN OIL	8470G57WFM	IACT
VITAMIN A PALMITATE	1D1K0N0VVC	IACT
CHOLECALCIFEROL	1C6V77QF41	IACT
PETROLATUM	4T6H12BN9U	ACTIB

Source Document#

Source XML · Source PDF

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
11484fca-45ce-e877-e063-6394a90a8bde			7a476687-d836-4775-9a8d-b9192b5955a0	2024-02-13	Warnings	Exact identifier spl id: 11484fca-45ce-e877-e063-6394a90a8bde spl set id: 7a476687-d836-4775-9a8d-b9192b5955a0

Reported adverse events (FAERS/openFDA)#

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