MARK 3- benzocaine gel

Land: USA

Språk: engelska

Källa: NLM (National Library of Medicine)

Aktiva substanser:

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

Tillgänglig från:

Cargus International, Inc.

Administreringssätt:

ORAL

Receptbelagda typ:

OTC DRUG

Terapeutiska indikationer:

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

Bemyndigande status:

OTC monograph not final

Produktens egenskaper

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%
PURPOS E
Oral Anesthetic
US ES
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
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
Cherry Dye Free
Gluten Free
with Vitamin E and Xylitol
NDC 61509-108-32
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 T YPE
HUMAN OTC DRUG
ITE M CODE (SOURCE )
NDC:6 150 9 -10 8
ROUTE OF ADMINISTRATION
ORAL, DENTAL
ACTIVE INGREDIENT/ACTIVE MOIETY
INGREDIENT NAME
BASIS OF STRENGTH
STRE N