Aloe Burn Relief

Manufacturer
DZA Brand | Product Quest Mfg
Effective date
2018-07-23
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 22:56:23

Label at a glance#

ProductAloe Burn Relief
Active ingredientLidocaine
Label structure6 sections

Indications and uses

Temporarily relieves pain and itching due to • sunburn • minor burns • minor cuts • scrapes • insect bites • minor skin irritation

Dosage and administration

• shake well • 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 • to apply to face, spray into palm of hand and gently apply

Label contents#

Full prescribing information#

Active ingredient                            Purpose

OTC - ACTIVE INGREDIENT SECTION

Lidocaine 0.5%                               External analgesic

Uses

INDICATIONS & USAGE SECTION

Temporarily relieves pain and itching due to

• sunburn • minor burns • minor cuts • scrapes

• insect bites • minor skin irritation

Warnings

WARNINGS SECTION

For external use only

Flammable: Do not spray while smoking or near heat or flame

SPL UNCLASSIFIED SECTION

Do not use in large quantities, particulary over raw surfaces or blistered areas.

OTC - DO NOT USE SECTION

When using this product

OTC - WHEN USING SECTION

  • keep out of your eyes
  • use only as directed
  • do not puncture or incinerate. Contents under pressure. Do not store at temperature above 120F.

Stop use and ask a doctor if

OTC - STOP USE SECTION

  • condition gets worse
  • symptoms last more than 7 days
  • symptoms clear up and occur again within a few days

Keep out of reach of the 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

• shake well
• 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

• to apply to face, spray into palm of hand and gently apply

Inactive ingredients

INACTIVE INGREDIENT SECTION

Aloe Barbadensis Leaf Juice, Carbomer, Diazolidinyl Urea, Disodium Cocoamphodipropionate, Disodium EDTA, Glycerin, Methylparaben, Propylene Glycol, Propylparaben, SD Alcohol 40, Simethicone, Tocopheryl Acetate, Triethanolamine

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

image descriptionimage description

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1442274lidocaine 0.5 % Topical SprayPSN1
1442274lidocaine 5 MG/ML Topical SpraySCD1
1442274lidocaine 0.5 % Topical SpraySY1

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
LIDOCAINE Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-130725439962735GTIN-13: 0725439962735
EAN-13: 0725439962735
GTIN-12: 725439962735
UPC-A: 725439962735
GTIN storage (14 digits): 00725439962735
label.jpg

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
55316-777-042020-01-31C16284748780-19d75b9d0-8fd4-f424-e053-dadaa90a57ceDrug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
55316-777-04Aloe Burn Relief127 g in 1 CANspray1271

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55316-777ALOE BURN RELIEF (LIDOCAINE 0.5%) SPRAY [DZA BRAND]1Legacy NDC, 1 package rows20180723_bf352da4-0899-4ff9-805f-e1b1c1f046cb.zip

Products#

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

DailyMed product names page 1 of 1 · 14 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
55316-77755316-777-04

Ingredients#

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

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

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
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
f31882d0-5797-4c66-936b-bb89e651372ebf352da4-0899-4ff9-805f-e1b1c1f046cb2018-07-23WarningsExact identifier
spl id: f31882d0-5797-4c66-936b-bb89e651372e
spl set id: bf352da4-0899-4ff9-805f-e1b1c1f046cb

Reported adverse events (FAERS/openFDA)#

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