FDA.reportPublic FDA data

ALOE VESTA PROTECTIVE BARRIER

Manufacturer
ConvaTec, Inc. | Aurena
Effective date
2011-04-08
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-05-31 22:27:42

Label at a glance#

ProductALOE VESTA PROTECTIVE BARRIER
Active ingredientPETROLATUM
Label structure8 sections

Indications and uses

Temporarily protects minor cuts scrapes burns. Temporarily protects and helps relieve chapped or cracked skin. Helps treat and prevent diaper rash. Protects minor skin irritation associated with diaper rash and helps seal out wetness.

Dosage and administration

Do not overspray.  Shake before use.  Hold can 4-6 inches from skin and spray. For skin protection Apply a thin continuous coating as needed. For diaper rash Change wet and soiled diapers promptly, cleanse the diaper area, and allow to dry.  Apply as needed, with each diaper change, especially at bedtime or any time when exposure to wet diapers may be prolonged.

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Petrolatum 36%

Purpose

OTC - PURPOSE SECTION

Skin Protectant

Uses

INDICATIONS & USAGE SECTION

  • Temporarily protects minor
  • cuts
  • scrapes
  • burns.

  • Temporarily protects and helps relieve chapped or cracked skin.
  • Helps treat and prevent diaper rash.
  • Protects minor skin irritation associated with diaper rash and helps seal out wetness.

Warnings

WARNINGS SECTION

For external use only.

Do not use on

OTC - DO NOT USE SECTION

  • deep or puncture wounds
  • animal bites
  • serious burns.

When using this product

OTC - WHEN USING SECTION

  • avoid spraying in eyes
  • do not intentionally inhale.

Stop use and see a doctor if

OTC - STOP USE SECTION

condition lasts more than 7 days.

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If swallowed, get medical help or contact a Poison Control Center right away.

Flammable

WARNINGS SECTION

Contents under pressure

  • Keep away from heat, sparks, and open flame.
  • Do not puncture or incinerate container.
  • Exposure to temperatures above 120oF may cause bursting.

Directions

DOSAGE & ADMINISTRATION SECTION

Do not overspray.  Shake before use.  Hold can 4-6 inches from skin and spray.

For skin protection

  • Apply a thin continuous coating as needed.
For diaper rash

  • Change wet and soiled diapers promptly, cleanse the diaper area, and allow to dry.  Apply as needed, with each diaper change, especially at bedtime or any time when exposure to wet diapers may be prolonged.

Other Information

SPL UNCLASSIFIED SECTION

Store at 15oC - 30oC (59oF - 86oF).

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Hexamethyldisiloxane, Softisan 649, Mineral Oil, Aloe Extract.

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL


Aloe Vesta Protective Barrier Spray Label
Aloe Vesta Protective Barrier Spray Label

NDC 43553-4134-1

ConvaTec

ALOE VESTATM

Protective Barrier Spray 3

PROTECT

SKIN PROTECTANT

Shake before use

Soothes irritated skin

For weepy, denuded skin

Apply from any angle

Easy to remove

NET WT. 2.1 oz.(60g)

CSX1876A  Case Order No. 413401

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
866791ALOE VESTA Protective Barrier 3, 36 % Topical SprayPSN3
672574petrolatum 36 % Topical SprayPSN3
866791petrolatum 360 MG/ML Topical Spray [Aloe Vesta Protective Barrier]SBD3
672574petrolatum 360 MG/ML Topical SpraySCD3
866791Aloe Vesta Protective Barrier 36 % Topical SpraySY3
866791Aloe Vesta Protective Barrier 360 MG/ML Topical SpraySY3
672574petrolatum 36 % Topical SpraySY3

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
43553-4134-12020-01-31C16284748780-19d75b9cf-f8ae-f424-e053-dadaa90a57ceDrug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
43553-4134-1ALOE VESTA PROTECTIVE BARRIER60 g in 1 CANSPRAY603

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
43553-4134ALOE VESTA PROTECTIVE BARRIER (PETROLATUM) SPRAY [CONVATEC, INC.]3Legacy NDC, 1 package rows20110411_10341c96-b4ba-4892-ab68-2ac66f29da96.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
43553-4134-1GM - Gram43553-4134e29099d6-81ae-4270-b78c-506c1242773612015-10-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
PETROLATUMACTIVE INGREDIENT4T6H12BN9U3
PETROLATUMACTIVE MOIETY4T6H12BN9U3
ALOE VERA LEAFINACTIVE INGREDIENTZY81Z83H0X3
HEXAMETHYLDISILOXANEINACTIVE INGREDIENTD7M4659BPU3
MINERAL OILINACTIVE INGREDIENTT5L8T28FGP3

Products#

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

DailyMed product names page 1 of 1 · 5 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
43553-413443553-4134-1

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 4 matching rows.

Name, UNII, Kind table
NameUNIIKind
PETROLATUM4T6H12BN9UACTIB
HEXAMETHYLDISILOXANED7M4659BPUIACT
MINERAL OILT5L8T28FGPIACT
ALOE VERA LEAFZY81Z83H0XIACT

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 · 30 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
MINERAL OILMINERAL OILT5L8T28FGPTABLET, DELAYED RELEASE / ORAL5.67 mgExact identifier — unii candidate
30 equally ranked IID candidates
MINERAL OILMINERAL OILT5L8T28FGPFILM / TRANSDERMAL11.42 mgExact identifier — unii candidate
30 equally ranked IID candidates
MINERAL OILMINERAL OILT5L8T28FGPPASTE / DENTAL95 %w/wExact identifier — unii candidate
30 equally ranked IID candidates
MINERAL OILMINERAL OILT5L8T28FGPTABLET, COATED / ORAL1.5 mgExact identifier — unii candidate
30 equally ranked IID candidates
MINERAL OILMINERAL OILT5L8T28FGPTABLET, CHEWABLE / ORAL6 mgExact identifier — unii candidate
30 equally ranked IID candidates
MINERAL OILMINERAL OILT5L8T28FGPCREAM / TOPICAL2772 mgExact identifier — unii candidate
30 equally ranked IID candidates
MINERAL OILMINERAL OILT5L8T28FGPFILM, EXTENDED RELEASE / TRANSDERMAL34 mgExact identifier — unii candidate
30 equally ranked IID candidates
MINERAL OILMINERAL OILT5L8T28FGPSUSPENSION / OPHTHALMIC0.1 %w/wExact identifier — unii candidate
30 equally ranked IID candidates
MINERAL OILMINERAL OILT5L8T28FGPLOTION / TOPICAL1428 mgExact identifier — unii candidate
30 equally ranked IID candidates
MINERAL OILMINERAL OILT5L8T28FGPOINTMENT / AURICULAR (OTIC)NAExact identifier — unii candidate
30 equally ranked IID candidates
MINERAL OILMINERAL OILT5L8T28FGPCAPSULE / ORAL120 mgExact identifier — unii candidate
30 equally ranked IID candidates
MINERAL OILMINERAL OILT5L8T28FGPSUPPOSITORY / RECTALNAExact identifier — unii candidate
30 equally ranked IID candidates
MINERAL OILMINERAL OILT5L8T28FGPSPRAY / TOPICAL1379 mgExact identifier — unii candidate
30 equally ranked IID candidates
MINERAL OILMINERAL OILT5L8T28FGPOINTMENT / OPHTHALMIC59.5 %w/wExact identifier — unii candidate
30 equally ranked IID candidates
MINERAL OILMINERAL OILT5L8T28FGPSYSTEM / TOPICAL654.36 mgExact identifier — unii candidate
30 equally ranked IID candidates
MINERAL OILMINERAL OILT5L8T28FGPPASTE / TOPICAL47.5 %w/wExact identifier — unii candidate
30 equally ranked IID candidates
MINERAL OILMINERAL OILT5L8T28FGPOINTMENT / TOPICAL9938 mgExact identifier — unii candidate
30 equally ranked IID candidates
MINERAL OILMINERAL OILT5L8T28FGPSUSPENSION / TOPICAL82 %w/wExact identifier — unii candidate
30 equally ranked IID candidates
MINERAL OILMINERAL OILT5L8T28FGPTABLET / ORAL113.75 mgExact identifier — unii candidate
30 equally ranked IID candidates
MINERAL OILMINERAL OILT5L8T28FGPSUPPOSITORY / VAGINAL30 mgExact identifier — unii candidate
30 equally ranked IID candidates
MINERAL OILMINERAL OILT5L8T28FGPTABLET, FILM COATED / ORALNAExact identifier — unii candidate
30 equally ranked IID candidates
MINERAL OILMINERAL OILT5L8T28FGPSOAP / TOPICAL0.82 %w/wExact identifier — unii candidate
30 equally ranked IID candidates
MINERAL OILMINERAL OILT5L8T28FGPSYSTEM / TRANSDERMAL6.09 mgExact identifier — unii candidate
30 equally ranked IID candidates
MINERAL OILMINERAL OILT5L8T28FGPTABLET, EXTENDED RELEASE / ORALNAExact identifier — unii candidate
30 equally ranked IID candidates
MINERAL OILMINERAL OILT5L8T28FGPDROPS / ORALNAExact identifier — unii candidate
30 equally ranked IID candidates
MINERAL OILMINERAL OILT5L8T28FGPCAPSULE, EXTENDED RELEASE / ORAL120 mgExact identifier — unii candidate
30 equally ranked IID candidates
MINERAL OILMINERAL OILT5L8T28FGPSUSPENSION / AURICULAR (OTIC)0.5 %w/vExact identifier — unii candidate
30 equally ranked IID candidates
MINERAL OILMINERAL OILT5L8T28FGPCREAM / VAGINAL402 mgExact identifier — unii candidate
30 equally ranked IID candidates
MINERAL OILMINERAL OILT5L8T28FGPGEL / TOPICAL2.5 %w/wExact identifier — unii candidate
30 equally ranked IID candidates
MINERAL OILMINERAL OILT5L8T28FGPOIL / TOPICAL43.29 %v/vExact identifier — unii candidate
30 equally ranked IID candidates

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
c83c8a0d-a979-4024-9f02-01392449ecbc10341c96-b4ba-4892-ab68-2ac66f29da962011-04-08WarningsExact identifier
spl id: c83c8a0d-a979-4024-9f02-01392449ecbc
spl set id: 10341c96-b4ba-4892-ab68-2ac66f29da96

Reported adverse events (FAERS/openFDA)#

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