FDA.reportPublic FDA data

772 Aloe Vesta Clear Barrier Spray

Manufacturer
Medline Industries, LP
Effective date
2022-09-19
Label type
HUMAN OTC DRUG LABEL
Version
5
Source
legacy-cache
Hydrated at
2026-08-01 21:53:27

Label at a glance#

ProductAloe Vesta
Active ingredientPETROLATUM
Label structure9 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 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 as needed For Diaper rash change wet and soiled diapers promptly, cleanse the diaper area and allow to dry apply product liberally as often as necessary 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

White petrolatum 36% w/w

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
  • protects minor skin irritation associated with diaper rash and helps seal out wetness

Warnings

WARNINGS SECTION

For external use only. Flammable; keep away from heat or flame

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
  • do not puncture or incinerate; contents under pressure

Stop using and see a doctor if

OTC - STOP USE SECTION

  • condition worsens
  • symptoms last 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

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

Directions

DOSAGE & ADMINISTRATION SECTION

  • do not overspray
  • shake before use
  • hold can 4-6 inches from skin and spray

For skin protection

  • apply as needed

For Diaper rash

  • change wet and soiled diapers promptly, cleanse the diaper area and allow to dry
  • apply product liberally as often as necessary with each diaper change, especially at bedtime or any time when exposure to wet diapers may be prolonged

Other information

OTHER SAFETY INFORMATION

  • store at 15°C-30°C (59°F-86°F)
  • for infants/neonates, please use under medical supervision

Inactive ingredients

INACTIVE INGREDIENT SECTION

aloe barbadensis leaf extract, bis-diglyceryl polyacyladipate-2, hexamethyldisiloxane, mineral oil

Manufacturing Information

SPL UNCLASSIFIED SECTION

Manufactured for Medline Industries, LP

Three Lakes Drive, Northfield, IL 60093 USA

Made in Sweden of foreign and domestic materials

www.medline.com

1-800-MEDLINE

REF: 413401

V1RE21AUE

Package Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Package labelPackage label

Products#

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

DailyMed product names page 1 of 1 · 6 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
53329-77253329-772-14

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 5 matching rows.

Name, UNII, Kind table
NameUNIIKind
MINERAL OILT5L8T28FGPIACT
HEXAMETHYLDISILOXANED7M4659BPUIACT
ALOE VERA LEAFZY81Z83H0XIACT
BIS-DIGLYCERYL POLYACYLADIPATE-26L246LAM9TIACT
PETROLATUM4T6H12BN9UACTIB

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
e90cb960-fa44-2822-e053-2a95a90a3ad0af5f4221-8376-bcf3-e053-2a95a90ad3aa2022-09-19WarningsExact identifier
spl id: e90cb960-fa44-2822-e053-2a95a90a3ad0
spl set id: af5f4221-8376-bcf3-e053-2a95a90ad3aa

Reported adverse events (FAERS/openFDA)#

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