GELATO TOPICAL ANESTHETIC- benzocaine gel

Land: USA

Sprog: engelsk

Kilde: NLM (National Library of Medicine)

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Hent Produktets egenskaber (SPC)
07-12-2023

Aktiv bestanddel:

Benzocaine 200mg (in each g)

Tilgængelig fra:

Mycone Dental Supply Co., Inc DBA Keystone Industries and Deepak Products Inc

Indgivelsesvej:

DENTAL

Recept type:

OTC DRUG

Terapeutiske indikationer:

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

Autorisation status:

OTC monograph not final

Produktets egenskaber

                                GELATO TOPICAL ANESTHETIC- BENZOCAINE GEL
MYCONE DENTAL SUPPLY CO., INC DBA KEYSTONE INDUSTRIES AND DEEPAK
PRODUCTS INC
----------
ACTIVE INGREDIENTS
Benzocaine 200mg (in each g)
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:
METHEMOGLOBINEMIA WARNING: Use of this product may cause
methemoglobinemia, a
serious condition that must be treated promptly because it reduces the
amount of
oxygen carried in the blood. This can occur even if you have used this
product before.
Stop use and seek immediate medical attention if you or a child in
your care develops:
pale, gray or blue colored skin (cyanosis)
headache
rapid heart rate
shortness of breath
dizziness or lightheadedness
fatigue or lack of energy
ALLERGY ALERT: Do not use on patients with a history of allergies to
local anesthetics
such as procaine, butacaine, benzocaine or other "caine" anesthetics.
DO NOT USE
for more than 7 days unless directed by a physician. 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 physician promptly.
for teething
in children under 2 years of age
WHEN USING THIS PRODUCT Avoid contact with eyes. If contact occurs,
flush with
water.
DO NOT EXCEED RECOMMENDED DOSAGE. If more than used for pain is
accidentally
swallowed, get medical help or contact a Poison Control Center right
away.
IF PREGNANT OR BREAST FEEDING, ask a physician before use.
DIRECTIONS
Apply only amount needed to the oral mucosa to prevent or relieve
pain.
children under 2 years of age: do not use
KEEP OUT OF REACH OF CHILDREN.
OTHER INFORMATION:
Store at 59°-86°F (15°-30°C). Protect from freezing.
INACTIVE INGREDIENTS:
Flavoring, PEG 3350, PEG 400, sodium saccharin. May contain blue #1,
green #3, green
#5, red #3, red #28, red #40, yellow#5 (tartrazine), yellow #6, as a
color additive.
QUESTIONS OR COMMENTS?
1-800-333-3131 or
keystoneindustries.com
GELATO TOPICAL ANE
                                
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