FDA.reportPublic FDA data

Acutens - Burn Relief Aloe Gel (80551-001)

Manufacturer
Acutens
Effective date
2026-01-08
Label type
HUMAN OTC DRUG LABEL
Version
7
Source
full-release
Hydrated at
2026-06-01 01:32:03

Label at a glance#

ProductBurn Relief Aloe
Active ingredientLIDOCAINE HYDROCHLORIDE
Label structure6 sections

Indications and uses

For temporary relief of pain and itching due to • sunburn • minor burns • insect bites • minor cuts • scrapes • minor skin irritation

Label contents#

Full prescribing information#

Active ingredients                                         Purpose

OTC - ACTIVE INGREDIENT SECTION

LIDOCAINE HYDROCHLORIDE               Pain Reliever

Uses:

INDICATIONS & USAGE SECTION

For temporary relief of pain and itching due to • sunburn • minor burns • insect bites • minor cuts • scrapes • minor skin irritation

Warnings For external use only

WARNINGS SECTION

When using this product• Avoid contact with eyes. Rinse with water if contact occurs.

Stop use and ask doctor if• symptoms persist for more than 7 days or clear up and occur again within a few days.

Do not usein large quantities, particularly over raw surfaces or blistered area

Direction

DOSAGE & ADMINISTRATION SECTION

adults and children over 2 years and older: • Apply to affected area not more than 3-4 times a day

• Children under 2 years old: consult a doctor

Inactive ingredients

INACTIVE INGREDIENT SECTION

Aloe Barbadensis Leaf Extract
Avena Sativa (Oat) Kernel Extract
Blue 1
Caprylyl Glycol
Chlorphenesin
Dimethyl Isosorbide
Glycerin
Hydroxyethylcellulose
Isopropyl Alcohol
Phenoxyethanol
Polysorbate 20
Propanediol
Tocopheryl Acetate
Water

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

image descriptionimage description

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1010077lidocaine HCl 4 % Topical GelPSN7
1010077lidocaine hydrochloride 0.04 MG/MG Topical GelSCD7
1010077lidocaine hydrochloride 4 % Topical GelSY7

DailyMed Pharmacologic Classes#

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

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
070fbed5-7088-434a-a7ce-f2a64d8d40acProduct name220260107
bee66ce1-adb7-9d3b-67d9-582e4c54e80fProduct name520250819
860a93dc-4863-49cc-b284-6bbe8191bc48Product name420250214
eaba870a-6a9d-442e-8643-87b3f558a451Product name120250117
6c13b22c-b3ba-4127-b768-0132dd5ab0d1Product name120230829
9b4cf230-fd05-41d5-98c6-5db9ecb27b86Product name120230117
7d755fa1-1087-4dcd-98f0-6d4bba479a57Product name320210602
aed701d5-9c75-dfaf-7154-cde46179faeaProduct name920200313
fa8b5901-e681-426f-82fe-54f6d81ec698Product name420180619
332d03e4-aa24-4b11-841a-02bf41081920Product name120171221
c08ab52f-2fc8-4409-9d9f-ed8edc0bd070Product name120171221
68ed98f8-24c2-44a0-944a-6d36e82ce25aProduct name120141222
1cd42bc2-a430-c72b-636d-991b235fbf80Product name120140508
49fa150c-f0de-cce7-3d9c-993ed81c5698Product name120140508
4d7ae718-ed00-bae8-2abe-9eaec1eef7ffProduct name120140508
9137811f-f279-8640-5aeb-99fa2145d64dProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
80551-001-03Burn Relief Aloe113 g in 1 BOTTLEGEL1137

Products#

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

DailyMed product names page 1 of 1 · 17 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
80551-00180551-001-03

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 14 matching rows.

Name, UNII, Kind table
NameUNIIKind
ALOEV5VD430YW9IACT
OATZ6J799EAJKIACT
CAPRYLYL GLYCOL00YIU5438UIACT
CHLORPHENESINI670DAL4SZIACT
DIMETHYL ISOSORBIDESA6A6V432SIACT
GLYCERINPDC6A3C0OXIACT
CETYL HYDROXYETHYLCELLULOSE (350000 MW)T7SWE4S2TTIACT
ISOPROPYL ALCOHOLND2M416302IACT
PHENOXYETHANOLHIE492ZZ3TIACT
POLYSORBATE 207T1F30V5YHIACT
PROPANEDIOL5965N8W85TIACT
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0IACT
WATER059QF0KO0RIACT
LIDOCAINE HYDROCHLORIDEV13007Z41AACTIR

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
Burn Relief AloeLIDOCAINE HCLAcutens48c435fe-2670-4b80-bf01-923dc93544222026-01-08WarningsExact identifier
ndc (package): 80551-001-03
ndc (product): 80551-001
ndc11 (package): 80551000103
spl id: 47e3e7d1-e703-b56c-e063-6294a90a8f8a
spl set id: 48c435fe-2670-4b80-bf01-923dc9354422

Reported adverse events (FAERS/openFDA)#

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