Alocane ® Severe Sunburn Gel

Manufacturer: Quest Products, Inc. | Fill Tech USA
Effective date: 2022-02-25
Label type: HUMAN OTC DRUG LABEL
Version: 4
Source: legacy-cache
Hydrated at: 2026-08-01 22:07:45

Label at a glance#

ProductAlocane Severe Sunburn

Active ingredientLIDOCAINE HYDROCHLORIDE

Label structure9 sections

Indications and uses

For the temporary relief of pain and itching associated with: Sunburn, Minor Burns, Insect Bites and minor Skin Irritation, Cuts and Scrapes.

Dosage and administration

Apply to affected area not more than 3 to 4 times daily. Children under 2 years of age, consult a physician. Do not use in large quantities, particularly over raw surfaces or blistered areas.

Storage and handling

Store in a cool, dry area.

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Lidocaine HCL 4%

Purpose

OTC - PURPOSE SECTION

Topical Analgesic

Uses

INDICATIONS & USAGE SECTION

For the temporary relief of pain and itching associated with: Sunburn, Minor Burns, Insect Bites and minor Skin Irritation, Cuts and Scrapes.

Warnings

WARNINGS SECTION

For external use only. Avoid contact with eyes.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.

OTC - STOP USE SECTION

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

OTC - PREGNANCY OR BREAST FEEDING SECTION

If pregnant or breast-feeding, ask a health care professional before use.

Directions

DOSAGE & ADMINISTRATION SECTION

Adults and children 2 years of age or older

SPL UNCLASSIFIED SECTION

Apply to affected area not more than 3 to 4 times daily. Children under 2 years of age, consult a physician. Do not use in large quantities, particularly over raw surfaces or blistered areas.

Other Information

STORAGE AND HANDLING SECTION

Store in a cool, dry area.

Inactive Ingredients

INACTIVE INGREDIENT SECTION

1,3-Propanediol, Aloe Barbadensis (Aloe) Leaf Juice, Dimethyl Isosorbide, Hydroxyethyl Cellulose, Phenoxyethanol, Chlorphenesin, Caprylyl Glycol, Tocopheryl Acetate (Vitamin E), Water.

SPL UNCLASSIFIED SECTION

Distributed by:
Quest Products, Inc.
Pleasant Prairie, WI 53158

PRINCIPAL DISPLAY PANEL - 75 ml Tube Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

4% Lidocaine
Maximum Strength

After
Sun

MAXIMUM STRENGTH
ALOCANE ^®

Severe
Sunburn Gel

Assists the Healing of Sunburned Skin
Cools and Rehydrates Skin
Soothing Aloe Gel & Vitamin E

Aloe
BRAZILIAN

Net Wt
2.5 fl. oz (75ml)

PRINCIPAL DISPLAY PANEL - 75 ml Tube Carton

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
68229-401-02	2020-02-03	C162847	48780-1	9d75b9cf-d256-f424-e053-dadaa90a57ce	Alocane ® Severe Sunburn Gel
68229-401-02	2020-01-31	C162847	48780-1	9d75b9cf-d256-f424-e053-dadaa90a57ce	Alocane ® Severe Sunburn Gel

Products#

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

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

Alocane Severe Sunburn
Lidocaine Hydrochloride
PROPANEDIOL
ALOE VERA LEAF
DIMETHYL ISOSORBIDE
HYDROXYETHYL CELLULOSE (5500 MPA.S AT 2%)
PHENOXYETHANOL
CHLORPHENESIN
CAPRYLYL GLYCOL
.ALPHA.-TOCOPHEROL ACETATE
WATER
LIDOCAINE
LIDOCAINE HYDROCHLORIDE ANHYDROUS

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
68229-401	68229-401-01, 68229-401-02

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 10 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
PROPANEDIOL	5965N8W85T	IACT
ALOE VERA LEAF	ZY81Z83H0X	IACT
DIMETHYL ISOSORBIDE	SA6A6V432S	IACT
HYDROXYETHYL CELLULOSE (5500 MPA.S AT 2%)	M825OX60H9	IACT
PHENOXYETHANOL	HIE492ZZ3T	IACT
CHLORPHENESIN	I670DAL4SZ	IACT
CAPRYLYL GLYCOL	00YIU5438U	IACT
.ALPHA.-TOCOPHEROL ACETATE	9E8X80D2L0	IACT
WATER	059QF0KO0R	IACT
LIDOCAINE HYDROCHLORIDE	V13007Z41A	ACTIR

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
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
d8db9d60-3eb2-dd3b-e053-2995a90a52f8			1302d9c5-929d-438f-8832-29d37057e8bd	2022-02-25	Warnings	Exact identifier spl id: d8db9d60-3eb2-dd3b-e053-2995a90a52f8 spl set id: 1302d9c5-929d-438f-8832-29d37057e8bd

Reported adverse events (FAERS/openFDA)#

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