IPANA 20% BENZOCAINE TOPICAL- benzocaine gel

Land: Verenigde Staten

Taal: Engels

Bron: NLM (National Library of Medicine)

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Download Productkenmerken (SPC)
29-11-2023

Werkstoffen:

BENZOCAINE (UNII: U3RSY48JW5) (BENZOCAINE - UNII:U3RSY48JW5)

Beschikbaar vanaf:

Maxill Inc.

INN (Algemene Internationale Benaming):

BENZOCAINE

Samenstelling:

BENZOCAINE 200 mg in 1 g

Toedieningsweg:

DENTAL

Prescription-type:

OTC DRUG

therapeutische indicaties:

Oral Anesthetic For oral mucosal use only, as directed by dentist. For the temporary relief of pain due to minor dental procedures.

Autorisatie-status:

OTC monograph not final

Productkenmerken

                                IPANA 20% BENZOCAINE TOPICAL- BENZOCAINE GEL
MAXILL INC.
----------
IPANA 20% BENZOCAINE TOPICAL STRAWBERRY
ACTIVE INGREDIENTS (IN EACH GRAM)
Benzocaine 200mg
PURPOSE
Oral Anesthetic
USE
For oral mucosal use only, as directed by dentist. For the temporary
relief of pain due to
minor dental procedures.
WARNINGS
​ALLERGY ALERT: ​Do not use on patients with a history of
allergies to local anesthetics
such as benzocaine or other "caine" anesthetics.
​DO NOT USE ​for more than 7 days unless directed by a dentist or
doctor. If sore mouth
symptoms do not improve in 7 days; irritation, pain, or redness
persists or worsens; or
if swelling, rash or fever develops, see your dentist or doctor
promptly.
​WHEN USING THIS PRODUCT ​
avoid contact with eyes. If contact occurs, flush with water.
​STOP USE AND CONSULT A HEALTH CARE PRACTITIONER ​if the following
symptoms appear:
weakness, confusion, headache, difficulty breathing, and/or pale, grey
or blue colored
skin, as these may be signs of methemoglobinemia, a rare disorder,
which may appear
up to 2 hours after use.
​DO NOT EXCEED RECOMMENDED DOSAGE. ​If more than used for pain is
accidentally
swallowed, get medical help or contact a Poison Control Center
immediately.
​IF PREGNANT OR BREASTFEEDING, ​ask a health professional before
use.
​KEEP OUT OF REACH OF CHILDREN.
DIRECTIONS
Apply only amount needed to the oral mucosa to prevent or relieve
pain.
OTHER INFORMATION
Store at 59°-86°F (15°-30°C). Protect from freezing.
INACTIVE INGREDIENTS
flavoring, PEG 3350, PEG 400, sodium saccharin. May contain yellow #5
(tartrazine),
yellow #6, red #3, red #40, blue #1, green #3 as a color additive.
QUESTIONS?
1-855-462-9455 or 1-519-631-7370
IPANA 20% BENZOCAINE TOPICAL
benzocaine gel
PRODUCT INFORMATION
PRODUCT TYPE
HUMAN OTC DRUG
ITEM CODE (SOURCE)
NDC:69510-358
ROUTE OF ADMINISTRATION
DENTAL
ACTIVE INGREDIENT/ACTIVE MOIETY
INGREDIENT NAME
BASIS OF STRENGTH
STRENGTH
BENZOCAINE (UNII: U3RSY48JW5) (BENZOCAINE - UNII:U3RSY48JW5)
BENZ OCAINE
200 mg in 1 g
INAC
                                
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