CICLOFERON- benzalkonium chloride and lidocaine hydrochloride gel
Laboratorios Liomont, S.A. de C.V.

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Drug Facts

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

CICLOFERON
benzalkonium chloride and lidocaine hydrochloride gel

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

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
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

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

#	Item Code	Package Description	Marketing Start Date
Packaging
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 Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part348	05/01/2019

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

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