VISTACAINE TOPICAL ANESTHETIC- benzocaine gel

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Inter-Med, INC.

Administration route:

DENTAL

Prescription type:

OTC DRUG

Therapeutic indications:

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

Authorization status:

OTC monograph not final

Summary of Product characteristics

VISTACAINE TOPICAL ANESTHETIC- BENZOCAINE GEL
INTER-MED, 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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ACTIVE INGREDIENTS (IN EACH GRAM)
Benzocaine 200 mg
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 BREAST FEEDING, ​ask a health professional before
use.
​KEEP OUT OF REACH OF CHILDREN.
Keep Out of Reach of Children.
​DIRECTIONS
Apply only amount needed to the oral mucosa to prevent or relieve
pain.
​OTHER INFORMATION
Store at 59º -86°F (15 - 30°C).
Protect from freezing.
​INACTIVE INGREDIENTS
​flavoring, PEG 3350, PEG 400, sodium saccharin, water. May contain
blue #1, green #5,
red #3, red #28, red #40, yellow #5 (tartrazine), as a color additive.
QUESTIONS OR COMMENTS?
1-262-636-9755
VISTACAINE TOPICAL ANESTHETIC
benzocaine gel
PRODUCT INFORMATION
PRODUCT TYPE
HUMAN OTC DRUG
ITEM CODE