CICLOFERON- benzalkonium chloride and lidocaine hydrochloride gel

United States - English - NLM (National Library of Medicine)

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Active ingredient:
Benzalkonium Chloride 0.13%, Lidocaine Hydrchloride 2%
Available from:
Laboratorios Liomont, S.A. de C.V.
Administration route:
TOPICAL
Prescription type:
OTC DRUG
Therapeutic indications:
Topical antiseptic Topical analgesic - provides temporary relief of pain associated with cold sores and fever blisters first aid to help protect against infection in minor cuts, scrapes, burns - first aid to help protect against infection in minor cuts, scrapes, burns - 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
Authorization status:
OTC monograph not final
Authorization number:
59208-002-04, 59208-002-05

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 T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:59 20 8 -0 0 2

Route of Administration

TOPICAL

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

BENZALKO NIUM CHLO RIDE (UNII: F5UM2KM3W7) (BENZALKONIUM -

UNII:7N6 JUD5X6 Y)

BENZALKONIUM CHLORIDE

1.3 mg

in 1 g

LIDO CAINE HYDRO CHLO RIDE (UNII: V130 0 7Z41A) (LIDOCAINE -

UNII:9 8 PI20 0 9 8 7)

LIDOCAINE HYDROCHLORIDE

ANHYDROUS

20 mg

in 1 g

Inactive Ingredients

Ingredient Name

Stre ng th

HYPRO MELLO SE, UNSPECIFIED (UNII: 3NXW29 V3WO)

METHYLPARABEN (UNII: A2I8 C7HI9 T)

PRO PYLENE GLYCO L (UNII: 6 DC9 Q16 7V3)

WATER (UNII: 0 59 QF0 KO0 R)

PO LYSO RBATE 8 0 (UNII: 6 OZP39 ZG8 H)

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

NDC:59 20 8 -0 0 2-0 4

1 in 1 CARTON

0 5/0 1/20 19

1

4 g in 1 TUBE; Type 0 : No t a Co mbinatio n Pro duct

2

NDC:59 20 8 -0 0 2-0 5

1 in 1 CONTAINER

0 5/0 1/20 19

Laboratorios Liomont, S.A. de C.V.

2

4 g in 1 TUBE; Type 0 : No t a Co mbinatio n Pro duct

Marketing Information

Marke ting Cate gory

Application Numbe r or Monograph Citation

Marke ting Start Date

Marke ting End Date

OTC mo no graph no t final

pa rt348

0 5/0 1/20 19

Labeler -

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

Establishment

Name

Ad d re s s

ID/FEI

Busine ss Ope rations

Labo rato rio s Lio mo nt, S.A. de C.V.

8 10 3478 0 7

ma nufa c ture (59 20 8 -0 0 2)

Revised: 5/2019

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