ALOCANE BOTANICALS- lidocaine hydrochloride spray

Alocane Botanicals by

Drug Labeling and Warnings

Alocane Botanicals by is a Otc medication manufactured, distributed, or labeled by Quest Products, LLC., Fill Tech USA. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

Active Ingredient

Lidocaine HCL 4%

Purpose

Topical Pain Relief

Uses

For the temporary relief of pain and itching associated with:

• Sunburn
• Minor Skin Irritation
• Minor Burns
• Minor Cuts & Scrapes
• Insect Bites

Warnings

For external use only. Avoid contact with eyes.

Do not use: ​

• in large quantities, or over large areas of the body
• Over raw surfaces or blistered areas
• If you have an allergy to any of the ingredients

Ask a doctor before use if you have a severe burn or deep cut, broken or compromised skin

Stop use and ask doctor:

• if condition worsens
• if symptoms persist for more than 7 days or clear up and occur again within a few days.

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

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

Directions:

Adults and Children 2 years of age or older:

Shake well. Apply top affected area not more than 3-4 times daily. To apply to face, spray on palm and carefully apply.

Children under 2 years of age, ask a doctor before use.

Other Information

Store at 15-30°C (59-86°F)

Inactive Ingredients

Water, Phenoxyethanol, Aloe Vera Leaf Juice, Lactobacilus Ferment, Echinacea Purpurea Root Extract, Calendula Officinalis Flower Extract, Sodium Hyaluronate, D-Panthenol, Glycerin, Hydroxyethyl Cellulose, Mannitol, Sodium Hydroxide

PRINCIPAL DISPLAY PANEL -- Alocane Botanicals 4oz Spray Bottle

INGREDIENTS AND APPEARANCE

ALOCANE BOTANICALS 
lidocaine hydrochloride spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 68229-405
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
LIDOCAINE HYDROCHLORIDE (UNII: V13007Z41A) (LIDOCAINE - UNII:98PI200987)	LIDOCAINE HYDROCHLORIDE ANHYDROUS	4 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
MANNITOL (UNII: 3OWL53L36A)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
LIMOSILACTOBACILLUS FERMENTUM (UNII: 2C1F12C6AP)
HYALURONATE SODIUM (UNII: YSE9PPT4TH)
GLYCERIN (UNII: PDC6A3C0OX)
ECHINACEA PURPUREA ROOT (UNII: OS64WTR4KU)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
HYDROXYETHYL CELLULOSE (5500 MPA.S AT 2%) (UNII: M825OX60H9)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
WATER (UNII: 059QF0KO0R)
CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD)
DEXPANTHENOL (UNII: 1O6C93RI7Z)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 68229-405-01	118 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product	08/11/2023
2	NDC: 68229-405-02	104 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product	08/11/2023

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	08/11/2023

Labeler - Quest Products, LLC. (075402441)

Establishment
Name	Address	ID/FEI	Business Operations
Fill Tech USA		926433855	manufacture(68229-405)