FDA.reportPublic FDA data

Aloe Vera Gel

Manufacturer
Vi-Jon, LLC
Effective date
2022-04-05
Label type
HUMAN OTC DRUG LABEL
Version
14
Source
legacy-cache
Hydrated at
2026-08-01 22:04:12

Label at a glance#

ProductAloe Vera Gel
Active ingredientLIDOCAINE HYDROCHLORIDE, MENTHOL
Label structure13 sections

Indications and uses

for the temporary relief of pain and itching associated with minor burns sunburn minor cuts scrapes insect bites minor skin irritations

Dosage and administration

adults and children 2 years of age and older: apply to affected area not more than 3 to 4 times daily children under 2 years of age: ask a doctor

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Lidocaine HCl 0.7%

Menthol 0.2%

Purpose

OTC - PURPOSE SECTION

topical analgesic

Uses

INDICATIONS & USAGE SECTION

for the temporary relief of pain and itching associated with

  • minor burns
  • sunburn
  • minor cuts
  • scrapes
  • insect bites
  • minor skin irritations

Warnings

WARNINGS SECTION

For external use only

When using this product

OTC - WHEN USING SECTION

avoid contact with the eyes

do not use

OTC - DO NOT USE SECTION

in large quantities, particularly over raw surfaces or blistered areas

Stop use and ask a doctor if

OTC - STOP USE SECTION

condition worsens, or if symptoms persist 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

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

Directions

DOSAGE & ADMINISTRATION SECTION

  • adults and children 2 years of age and older: apply to affected area not more than 3 to 4 times daily
  • children under 2 years of age: ask a doctor

inactive ingredients

INACTIVE INGREDIENT SECTION

water, alcohol, glycerin, polysorbate 80, carbomer, Aloe barbadensis leaf juice, benzophenone-4, triethanolamine, imidazolidinyl urea, blue 1

claims

SPL UNCLASSIFIED SECTION

Made in the USA

with US and foreign parts

Adverse Reactions Section

Manufactured by: Vi-Jon, LLC

St. Louis, MO 63114

Questions or Comments?

1-888-593-0593

principal display panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

mountain

falls

cools &

soothes

with

lidocaine

& menthol

relieving

after sun

aloe gel

topical analgesic

16 FL OZ (473 mL)

image descriptionimage description

Products#

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

DailyMed product names page 1 of 1 · 16 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
11344-74711344-747-43

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 12 matching rows.

Name, UNII, Kind table
NameUNIIKind
LIDOCAINE HYDROCHLORIDEV13007Z41AACTIR
MENTHOLL7T10EIP3AACTIB
water059QF0KO0RIACT
ALCOHOL3K9958V90MIACT
GLYCERINPDC6A3C0OXIACT
POLYSORBATE 806OZP39ZG8HIACT
CARBOMER COPOLYMER TYPE A71DD5V995LIACT
ALOE VERA LEAFZY81Z83H0XIACT
SULISOBENZONE1W6L629B4KIACT
TROLAMINE9O3K93S3TKIACT
IMIDUREAM629807ATLIACT
FD&C BLUE NO. 1H3R47K3TBDIACT

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
10cc8204-bb3e-32e0-e063-6294a90af57a8bb1b66b-96b2-4250-b278-d9db71c287f42024-02-07Warnings, Adverse reactionsExact identifier
spl set id: 8bb1b66b-96b2-4250-b278-d9db71c287f4

Reported adverse events (FAERS/openFDA)#

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