CICLOFERON- benzalkonium chloride and lidocaine hydrochloride gel

Land: USA

Sprog: engelsk

Kilde: NLM (National Library of Medicine)

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Produktets egenskaber Produktets egenskaber (SPC)
16-05-2019

Aktiv bestanddel:

BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y), LIDOCAINE HYDROCHLORIDE (UNII: V13007Z41A) (LIDOCAINE - UNII:98PI200987)

Tilgængelig fra:

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

Indgivelsesvej:

TOPICAL

Recept type:

OTC DRUG

Terapeutiske indikationer:

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

Autorisation status:

OTC monograph not final

Produktets egenskaber

                                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._
----------
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
                                
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