COMFORTCAINE TOPICAL ANESTHETIC- benzocaine gel

Land: USA

Sprog: engelsk

Kilde: NLM (National Library of Medicine)

Aktiv bestanddel:

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

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. - 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 - if swelling, rash or fever develops, see your dentist or doctor promptly. If the following symptoms appear: weakness, confusion, headache, difficulty breathing and/or pale, gray, or blue coloured skin, as these may be signs of methemoglobinemia, a rare disorder, which may appear up to 2 hours after use.

Autorisation status:

OTC monograph not final

Produktets egenskaber

COMFORTCAINE TOPICAL ANESTHETIC- BENZOCAINE GEL
MYCONE DENTAL SUPPLY CO., INC DBA KEYSTONE INDUSTRIES AND DEEPAK
PRODUCTS INC
_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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COMFORTCAINE PINA COLADA
ACTIVE INGREDIENTS (IN EACH GRAM)
Benzocaine 200 mg
PURPOS E
Oral Anesthetic
US ES
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
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,
gray, or blue coloured 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 BREAST FEEDING,
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° to 86°F (15° to 30°C). Protect from freezing.
INACTIVE INGREDIENTS
Flavoring, polyethylene glycol base, sodium saccharin. May contain
blue #1, red #3, red #33, red #40,
yellow #6, yellow #10.
QUESTIONS OR COMMENTS?
1-800-333-3131 or 856-663-4700
www.keystoneind.com
PRINCIPLE DISPLAY PANEL
Bosworth ® ComfortCaine™
Topical Anesthetic
1 oz. (30g.)
BOSLA