FDA.reportPublic FDA data

Alocane

Manufacturer
Quest Products, Inc. | Fill Tech USA
Effective date
2022-02-25
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
legacy-cache
Hydrated at
2026-08-01 22:07:49

Label at a glance#

ProductAlocane
Active ingredientLIDOCAINE HYDROCHLORIDE, HYDROCORTISONE ACETATE
Label structure9 sections

Indications and uses

Scar management. For temporary relief of itching associated with minor skin irritations, inflammation and rashes.

Dosage and administration

Children from 2-12 years of age ask a doctor Clean affected area with mild soap and water, dry thoroughly, apply twice daily. Allow to dry for 1 minute before coming into contact with clothing.

Storage and handling

Store at 15° to 30° C (59° to 86°F)

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

OTC - PURPOSE SECTION

Active IngredientPurpose
Silicones 94.5%Scar Management
Hydrocortisone Acetate .5%Anti-Pruritic

Uses

INDICATIONS & USAGE SECTION

Scar management. For temporary relief of itching associated with minor skin irritations, inflammation and rashes.

Warnings

WARNINGS SECTION

For external use only.

OTC - DO NOT USE SECTION

Do not use on children under 2 years of age. Consult a doctor. Do not use on mucous membranes.

OTC - WHEN USING SECTION

When using this product avoid contact with eyes.

OTC - STOP USE SECTION

Stop use and ask a doctor if condition worsens or symptoms persist for more than 7 days.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. If swallowed, get medical help or contact Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

Children from 2-12 years of age ask a doctor

Clean affected area with mild soap and water, dry thoroughly, apply twice daily. Allow to dry for 1 minute before coming into contact with clothing.

Other Information

STORAGE AND HANDLING SECTION

Store at 15° to 30° C (59° to 86°F)

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Allium Cepa (Onion) Bulb Extract, Aloe Barbadensis (Aloe) Leaf Juice, Dimethicone, Dimethicone Crosspolymer, Glycerine Soja (Soybean) Oil, Helianthus Annuus (Sunflower) Seed Oil, Helichrysum Italicum (Everlasting) Extract

SPL UNCLASSIFIED SECTION

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

PRINCIPAL DISPLAY PANEL - 75 mL Tube Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Onion Bulb
Silicone
+

ADVANCED STRENGTH
ALOCANE ®

Scar Prevention
Therapy Gel

  • Specially Formulated to Prevent the
    Formation of Scars
  • Reduces Visibility of Old Scars
  • Restores Elasticity to tissue
  • Smooths and Softens Skin

Recommended by
Physicians and Pharmacists

MADE IN THE
USA

Net Wt
2.5 fl. oz (75ml)

PRINCIPAL DISPLAY PANEL - 75 mL Tube Carton
PRINCIPAL DISPLAY PANEL - 75 mL Tube Carton

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
68229-400-022022-02-25C16284748780-19d75b9d1-20ac-f424-e053-dadaa90a57ceAlocane ®
68229-400-022020-01-31C16284748780-19d75b9d1-20ac-f424-e053-dadaa90a57ceAlocane ®

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
HYDROCORTISONE ACETATEACTIVE INGREDIENT3X7931PO741
LIDOCAINE HYDROCHLORIDEACTIVE INGREDIENTV13007Z41A1
HYDROCORTISONEACTIVE MOIETYWI4X0X7BPJ1
LIDOCAINEACTIVE MOIETY98PI2009871
ALOE VERA LEAFINACTIVE INGREDIENTZY81Z83H0X1
DIMETHICONEINACTIVE INGREDIENT92RU3N3Y1O1
HELICHRYSUM ITALICUM FLOWERINACTIVE INGREDIENTP62Y550X241
ONIONINACTIVE INGREDIENT492225Q21H1
SOYBEAN OILINACTIVE INGREDIENT241ATL177A1
SUNFLOWER OILINACTIVE INGREDIENT3W1JG795YI1

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
68229-40068229-400-01, 68229-400-02

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 8 matching rows.

Name, UNII, Kind table
NameUNIIKind
ONION492225Q21HIACT
ALOE VERA LEAFZY81Z83H0XIACT
DIMETHICONE92RU3N3Y1OIACT
SOYBEAN OIL241ATL177AIACT
SUNFLOWER OIL3W1JG795YIIACT
HELICHRYSUM ITALICUM FLOWERP62Y550X24IACT
LIDOCAINE HYDROCHLORIDEV13007Z41AACTIR
HYDROCORTISONE ACETATE3X7931PO74ACTIB

Source Document#

Source XML

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 1 · 7 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
SOYBEAN OILSOYBEAN OIL241ATL177AINJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / INTRAVENOUS10 %w/vExact identifier — unii candidate
7 equally ranked IID candidates
SOYBEAN OILSOYBEAN OIL241ATL177AAEROSOL, FOAM / TOPICAL50 %w/wExact identifier — unii candidate
7 equally ranked IID candidates
SOYBEAN OILSOYBEAN OIL241ATL177AINJECTION, EMULSION / INTRAVENOUS107100 mgExact identifier — unii candidate
7 equally ranked IID candidates
SOYBEAN OILSOYBEAN OIL241ATL177AINJECTION, SOLUTION, CONCENTRATE / INTRAVENOUS223 mgExact identifier — unii candidate
7 equally ranked IID candidates
SOYBEAN OILSOYBEAN OIL241ATL177ACAPSULE / ORAL1318 mgExact identifier — unii candidate
7 equally ranked IID candidates
SOYBEAN OILSOYBEAN OIL241ATL177ASOLUTION / TOPICAL5.82 %w/wExact identifier — unii candidate
7 equally ranked IID candidates
SOYBEAN OILSOYBEAN OIL241ATL177AINJECTION / INTRAVENOUS10 %w/vExact identifier — unii candidate
7 equally ranked IID candidates

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
d8db9d60-3eb1-dd3b-e053-2995a90a52f8ba6f045b-06a9-4fee-a06f-25aef37b70192022-02-25WarningsExact identifier
spl id: d8db9d60-3eb1-dd3b-e053-2995a90a52f8
spl set id: ba6f045b-06a9-4fee-a06f-25aef37b7019

Reported adverse events (FAERS/openFDA)#

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