CICLOFERON- benzalkonium chloride and lidocaine hydrochloride gel

CICLOFERON by

Drug Labeling and Warnings

CICLOFERON by is a Otc medication manufactured, distributed, or labeled by Laboratorios Liomont, S.A. de C.V.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredients

Benzalkonium Chloride 0.13%

Lidocaine Hydrchloride 2%

Purpose

Topical antiseptic

Topical analgesic

Uses

• provides temporary relief of pain associated with cold sores and fever blisters
  • first aid to help protect against infection in minor cuts, scrapes, burns

Warnings

For external use only:

Do not use in the eyes or apply over large areas of the body. In case of deep puncture wounds, animal bites, or serious burns, consult a doctor.

Do not use

• for more than 7 days unless told to do so by a doctor
• more than directed
• if you are allergic to any ingredient in this product

When using this product

• avoid contact with the eyes

Stop use and ask a doctor if

Keep out of reach of children

If swallowed, get medical help or contact a Poison Control Center immediately.

Directions

• clean the affected area
• apply a small amount of this product to the affected area 1 to 3 times daily
• may be covered with a sterile bandage
• children under 12 years of age, consult a doctor

Other Information

• store at 20° to 25°C (68° to 77°F)

Inactive Ingredients

hypromellose, methylparaben, propylene glycol, water, polysorbate 80

Package Label

INGREDIENTS AND APPEARANCE

CICLOFERON 
benzalkonium chloride and lidocaine hydrochloride gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 59208-002
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y)	BENZALKONIUM CHLORIDE	1.3 mg  in 1 g
LIDOCAINE HYDROCHLORIDE (UNII: V13007Z41A) (LIDOCAINE - UNII:98PI200987)	LIDOCAINE HYDROCHLORIDE ANHYDROUS	20 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)
METHYLPARABEN (UNII: A2I8C7HI9T)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
WATER (UNII: 059QF0KO0R)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 59208-002-04	1 in 1 CARTON	05/01/2019
1		4 g in 1 TUBE; Type 0: Not a Combination Product
2	NDC: 59208-002-05	1 in 1 CONTAINER	05/01/2019
2		4 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	05/01/2019

Labeler - Laboratorios Liomont, S.A. de C.V. (810347807)

Establishment
Name	Address	ID/FEI	Business Operations
Laboratorios Liomont, S.A. de C.V.		810347807	manufacture(59208-002)