FDA.reportPublic FDA data

Alocane Advanced Scar & Itch Gel

Manufacturer
Quest Products, LLC | Filltech USA, LLC
Effective date
2024-11-05
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 02:28:51

Label at a glance#

ProductAlocane Advanced Scar and Itch
Active ingredientGRINDELIA HIRSUTULA FLOWERING TOP, CALENDULA OFFICINALIS FLOWER
Label structure8 sections

Indications and uses

Helps promote healing of cuts, scrapes, chafing, minor burns, and minor skin irritations Temprarily relieves the pain and itching of skin and rashes due to insect bites, minor cuts, scrapes and burns

Dosage and administration

Adults and children 2 years of age and older: Clean affected area with soap and water. Apply to affected area as needed up to 3 times daily. Children under 2 years of age: Ask a doctor.

Label contents#

Full prescribing information#

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Calendula officinalis 1X HPUS 0.8%

Grindelia Robusta 1X HPUS 0.4%

Purpose

OTC - PURPOSE SECTION

Wound Healing / Scar Prevention

Anti-itch / Pain relief

Uses

INDICATIONS & USAGE SECTION

  • Helps promote healing of cuts, scrapes, chafing, minor burns, and minor skin irritations
  • Temprarily relieves the pain and itching of skin and rashes due to insect bites, minor cuts, scrapes and burns

Warnings

WARNINGS SECTION

FOR EXTERNAL USE ONLY

Do not use if you are allergic to Calendula officinalis, Grindelia robusta, or any of the product's inactive ingredients.

When using this product:

OTC - WHEN USING SECTION

  • Do not get into eyes.

Stop use and ask a doctor if:

OTC - STOP USE SECTION

  • Condition worsens, or if symptoms persist for more than 7 days.

If pregnant or breast-feeding,

OTC - PREGNANCY OR BREAST FEEDING SECTION

ask a health care professional before use.

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: Clean affected area with soap and water. Apply to affected area as needed up to 3 times daily.

Children under 2 years of age: Ask a doctor.

Other Information

SPL UNCLASSIFIED SECTION

  • Store at room temperature (59-86 0F / 15-30 0C)
  • The letters HPUS indicate the components in this product are officially monographed in the Homeopathic Pharmacopoeia of the United States.

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Allum Cepa (onion) Bulb Extract, Aloe Barbadensis Leaf Extract, Carthamus Tinctorius (Safflower) Oil, Citrus Aurantium Bergamia Peel Oil, Dimethicone, Dimethicone Crosspolymer, Glycine Soja (Soybean) Oil, Helianthus Annuus (Sunflower) Seed Oil, Helchrysum Italicum (Everlasting) Extract.

Package Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

pdppdp

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68229-409-01Alocane Advanced Scar and Itch20.7 mL in 1 TUBEGEL20.71
68229-409-02Alocane Advanced Scar and Itch1 in 1 CARTONGEL11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68229-409ALOCANE ADVANCED SCAR AND ITCH (CALENDULA OFFICINALIS, GRINDELIA ROBUSTA) GEL [QUEST PRODUCTS, LLC]1Current NDC, 2 package rows20241109_26301c2d-6d13-ec1d-e063-6394a90ac524.zip

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
68229-40968229-409-01, 68229-409-02

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
GRINDELIA HIRSUTULA FLOWERING TOPIDB0NAZ6AIACTIB
CARTHAMUS TINCTORIUS (SAFFLOWER) OLEOSOMES9S60Q72309IACT
ALOE BARBADENSIS LEAF EXTRACTZY81Z83H0XIACT
DIMETHICONE92RU3N3Y1OIACT
CITRUS AURANTIUM BERGAMIA (BERGAMOT) PEEL OIL39W1PKE3JIIACT
HELIANTHUS ANNUUS (SUNFLOWER) SEED OIL3W1JG795YIIACT
DIMETHICONE CROSSPOLYMERUF7620L1W6IACT
GLYCINE SOJA (SOYBEAN) OIL241ATL177AIACT
CALENDULA OFFICINALIS FLOWERP0M7O4Y7YDACTIB
ONION492225Q21HIACT
GAMOCHAETA PURPUREA FLOWERKQV867ADR4IACT

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
Alocane Advanced Scar and ItchCALENDULA OFFICINALIS, GRINDELIA ROBUSTAQuest Products, LLC26301c2d-6d13-ec1d-e063-6394a90ac5242024-11-05WarningsExact identifier
ndc (package): 68229-409-02
ndc (package): 68229-409-01
ndc (product): 68229-409
ndc11 (package): 68229040902
ndc11 (package): 68229040901
spl id: 26301c2d-6d14-ec1d-e063-6394a90ac524
spl set id: 26301c2d-6d13-ec1d-e063-6394a90ac524

Reported adverse events (FAERS/openFDA)#

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