ALOCANE PLUS- lidocaine hydrochloride and benzalkonium chloride gel

Alocane Plus by

Drug Labeling and Warnings

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

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

Active Ingredients

Benzalkonium Chloride 0.13%

Lidocaine HCl 4.0%

Purpose

First Aid Antiseptic

Topical Analgesic

Uses

First Aid to help prevent bacterial infection associated with contamination of the skin. Temporarily relieves pain and itching due to:

• minor cuts
• scrapes
• minor burns

Warnings

For external use only. Avoid contact with eyes.

Keep out of reach of children. In case of accidental ingestion, get medical help or contact a Poison Control Center right away.

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.

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.

Do not use:

in large quantities, particularly over raw surfaces or blistered areas.

If pregnant or breast-feeding

ask a health care professional before use.

Directions:

Adults and children 2 years of age or older:

• Shake well
• Clean the affected area
• Spray on the affected area 1 to 3 times daily
• May be covered with a sterile bandage after drying

Children under 2 years of age: consult a doctor

Other Information

Store at room temperature of 15° - 30°C (59° - 86°F)

Inactive Ingredients

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

PRINCIPAL DISPLAY PANEL - 3.5 fl oz Spray

INGREDIENTS AND APPEARANCE

ALOCANE PLUS 
lidocaine hydrochloride and benzalkonium chloride gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 68229-404
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
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y)	BENZALKONIUM CHLORIDE	0.13 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
PROPANEDIOL (UNII: 5965N8W85T)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
DIMETHYL ISOSORBIDE (UNII: SA6A6V432S)
HYDROXYETHYL CELLULOSE (5500 MPA.S AT 2%) (UNII: M825OX60H9)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
CHLORPHENESIN (UNII: I670DAL4SZ)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 68229-404-01	104 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product	12/03/2021

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M017	12/03/2021

Labeler - Quest Products, Inc. (075402441)

Establishment
Name	Address	ID/FEI	Business Operations
Fill Tech USA		926433855	manufacture(68229-404)