ALOCANE ADVANCED SCAR AND ITCH- calendula officinalis, grindelia robusta gel

Alocane Advanced Scar and Itch by

Drug Labeling and Warnings

Alocane Advanced Scar and Itch by is a Homeopathic medication manufactured, distributed, or labeled by Quest Products, LLC, Filltech USA, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredients

Calendula officinalis 1X HPUS 0.8%

Grindelia Robusta 1X HPUS 0.4%

Purpose

Wound Healing / Scar Prevention

Anti-itch / Pain relief

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

Warnings

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:

• Do not get into eyes.

Stop use and ask a doctor if:

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

If pregnant or breast-feeding,

ask a health care professional before use.

Keep out of reach of children.

If swallowed, get medical help or contact a poison control center right away.

Directions

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

• 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

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

INGREDIENTS AND APPEARANCE

ALOCANE ADVANCED SCAR AND ITCH 
calendula officinalis, grindelia robusta gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 68229-409
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
GRINDELIA HIRSUTULA FLOWERING TOP (UNII: IDB0NAZ6AI) (GRINDELIA HIRSUTULA FLOWERING TOP - UNII:IDB0NAZ6AI)	GRINDELIA HIRSUTULA FLOWERING TOP	1 [hp_X]  in 20.7 mL
CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD) (CALENDULA OFFICINALIS FLOWER - UNII:P0M7O4Y7YD)	CALENDULA OFFICINALIS FLOWER	1 [hp_X]  in 20.7 mL

Inactive Ingredients
Ingredient Name	Strength
CARTHAMUS TINCTORIUS (SAFFLOWER) OLEOSOMES (UNII: 9S60Q72309)
ALOE BARBADENSIS LEAF EXTRACT (UNII: ZY81Z83H0X)
DIMETHICONE (UNII: 92RU3N3Y1O)
CITRUS AURANTIUM BERGAMIA (BERGAMOT) PEEL OIL (UNII: 39W1PKE3JI)
HELIANTHUS ANNUUS (SUNFLOWER) SEED OIL (UNII: 3W1JG795YI)
DIMETHICONE CROSSPOLYMER (UNII: UF7620L1W6)
GLYCINE SOJA (SOYBEAN) OIL (UNII: 241ATL177A)
ONION (UNII: 492225Q21H)
GAMOCHAETA PURPUREA FLOWER (UNII: KQV867ADR4)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 68229-409-02	1 in 1 CARTON	11/05/2024
1	NDC: 68229-409-01	20.7 mL in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved homeopathic		11/05/2024

Labeler - Quest Products, LLC (075402441)

Establishment
Name	Address	ID/FEI	Business Operations
Filltech USA, LLC		926433855	manufacture(68229-409)