MARK 3- benzocaine gel

מדינה: ארצות הברית

שפה: אנגלית

מקור: NLM (National Library of Medicine)

מרכיב פעיל:

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

זמין מ:

Cargus International, Inc.

מסלול נתינה (של תרופות):

ORAL

סוג מרשם:

OTC DRUG

סממני תרפויטית:

Oral Anesthetic For the temporary relief of pain associated with canker sores and minor dental procedures.

מצב אישור:

OTC monograph not final

מאפייני מוצר

MARK 3- BENZOCAINE GEL
CARGUS INTERNATIONAL, 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._
----------
ACTIVE INGREDIENT
Benzocaine, 20%
PURPOSE
Oral Anesthetic
USES
For the temporary relief of pain associated with canker sores and
minor dental
procedures.
WARNINGS
ALLERGY ALERT Do not use this product if you have a history of allergy
to local anesthetics
such as procaine, butacaine, benzocaine, or other "-caine"
anesthetics.
DO NOT
use this product for more than 7 days unless directed by a dentist or
doctor. If sore
mouth symptoms do not improve in 7 days; if irritation, pain, or
redness persists or
worsens; or if swelling, rash or fever develops, see your dentist or
doctor promptly.
DO NOT
exceed recommended dosage.
KEEP OUT OF REACH OF CHILDREN.
IF MORE THAN USED FOR PAIN IS ACCIDENTIALLY SWALLOWED, GET MEDICAL
HELP OR
CONTACT A POISON CONTROL CENTER RIGHT AWAY.
DIRECTIONS
Adults and children 12 years of age and older: Apply to the affected
area. Use up to 4
times daily or as directed by a dentist or doctor
Children under 12 years of age should be supervised in the use of the
product.
Children under 2 years of age: Consult a dentist or doctor.
OTHER INFORMATION
Store at room temperature 59 - 86°F (15 - 30°C). Protect from
freezing and heat.
INACTIVE INGREDIENTS
FD&C Green No. 3, FD&C Yellow No. 5, Flavor, Polyethylene glycol 3350,
Polyethylene
glycol 400, Saccharine sodium, Tocopheryl acetate, Xylitol
DISTRIBUTED BY
Mark 3, 135 North Rt. 9W, Congers, NY 10920
1.888.732.2913
Mark 3
Oral Anesthetic Gel
Mint
Gluten Free
with Vitamin E and Xylitol
NDC 61509-102-32
Net Wt. 1.12 oz. (32 g)
Distributed by Mark 3, 135 North Rt. 9W, Congers, NY 10920
Made in USA
MARK 3
benzocaine gel
PRODUCT INFORMATION
PRODUCT TYPE
HUMAN OTC DRUG
ITEM CODE (SOURCE)
NDC:61509-102
ROUTE OF ADMINISTRATION
ORAL, DENTAL
ACTIVE INGREDIENT/ACTIVE MOIETY
INGREDIENT NAME
BASIS