FDA.reportPublic FDA data

Alcoholada Gel Pain Relieving Gel

Manufacturer
Aruba Aloe Balm NV
Effective date
2023-11-06
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
legacy-cache
Hydrated at
2026-08-01 21:21:36

Label at a glance#

ProductAlcoholada Pain Relieving
Active ingredientLIDOCAINE HYDROCHLORIDE
Label structure7 sections

Indications and uses

For the temporary relief of pain and itching associated with minor burns, sunburn, insect bites, or 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: Consult a doctor.

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Lidocaine Hydrochloride 0.5%

Purpose

OTC - PURPOSE SECTION

Pain Relieving Gel

Uses

INDICATIONS & USAGE SECTION

For the temporary relief of pain and itching associated with minor burns, sunburn, insect bites, or minor skin irritations.

Warnings

WARNINGS SECTION

For external use only.

Do not use

OTC - DO NOT USE SECTION

in large quantities, particularly over raw surfaces or blistered areas.

When using this product 

OTC - WHEN USING SECTION

avoid contact with the eyes.

Stop use and ask a doctor if

OTC - STOP USE SECTION

conditions worsens, or if symptoms persist for more than 7 days or clears 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: Consult a doctor.

Other Information

SPL UNCLASSIFIED SECTION

• Store in a cool dry place

• Protect from hear and light

Inactive ingredients

INACTIVE INGREDIENT SECTION

Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Alcohol Denat., Aloe Vera (Aloe Barbadensis) Gel, Caprylyl Glycol, Chlorphenesin, FD&C Blue No.1, Fragrance (Parfum), Phenoxyethanol, Polysorbate 20, Sodium Hydroxide, Water (Aqua).

Package Labeling:

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LabelLabel

Products#

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

DailyMed product names page 1 of 1 · 13 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
53675-16453675-164-00

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 11 matching rows.

Name, UNII, Kind table
NameUNIIKind
CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED)59TL3WG5COIACT
ALCOHOL3K9958V90MIACT
ALOE VERA LEAFZY81Z83H0XIACT
CAPRYLYL GLYCOL00YIU5438UIACT
CHLORPHENESINI670DAL4SZIACT
FD&C BLUE NO. 1H3R47K3TBDIACT
PHENOXYETHANOLHIE492ZZ3TIACT
POLYSORBATE 207T1F30V5YHIACT
SODIUM HYDROXIDE55X04QC32IIACT
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
129ace05-0f21-a8e8-e063-6394a90ae4207ec2a1b2-d59b-43df-85cb-0e84817fe1562024-03-01WarningsExact identifier
spl set id: 7ec2a1b2-d59b-43df-85cb-0e84817fe156

Reported adverse events (FAERS/openFDA)#

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