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NDC 59208-0002-04 CICLOFERON 1.3; 20 mg/g; mg/g Details

CICLOFERON 1.3; 20 mg/g; mg/g

CICLOFERON is a TOPICAL GEL in the HUMAN OTC DRUG category. It is labeled and distributed by Laboratorios Liomont, S.A. de C.V.. The primary component is BENZALKONIUM CHLORIDE; LIDOCAINE HYDROCHLORIDE.

Product Information

NDC	59208-0002
Product ID	59208-002_89080d3c-70e2-7f07-e053-2995a90a6230
Associated GPIs
GCN Sequence Number	n/a
GCN Sequence Number Description	n/a
HIC3	n/a
HIC3 Description	n/a
GCN	n/a
HICL Sequence Number	n/a
HICL Sequence Number Description	n/a
Brand/Generic	n/a
Proprietary Name	CICLOFERON
Proprietary Name Suffix	n/a
Non-Proprietary Name	benzalkonium chloride and lidocaine hydrochloride
Product Type	HUMAN OTC DRUG
Dosage Form	GEL
Route	TOPICAL
Active Ingredient Strength	1.3; 20
Active Ingredient Units	mg/g; mg/g
Substance Name	BENZALKONIUM CHLORIDE; LIDOCAINE HYDROCHLORIDE
Labeler Name	Laboratorios Liomont, S.A. de C.V.
Pharmaceutical Class	Amide Local Anesthetic [EPC], Amides [CS], Antiarrhythmic [EPC], Local Anesthesia [PE]
DEA Schedule	n/a
Marketing Category	OTC MONOGRAPH NOT FINAL
Application Number	part348
Listing Certified Through	2024-12-31

Package

Package Images

NDC 59208-0002-04 (59208000204)

Pricing Information	N/A
NDC Package Code	59208-002-04
Billing NDC	59208000204
Package	1 TUBE in 1 CARTON (59208-002-04) / 4 g in 1 TUBE
Marketing Start Date	2019-05-01
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL 89081ef8-9721-a476-e053-2995a90ae0de Details

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

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)

Revised: 5/2019

Document Id: 89080d3c-70e2-7f07-e053-2995a90a6230

Set id: 89081ef8-9721-a476-e053-2995a90ae0de

Version: 1

Effective Time: 20190516