BENCOCAINE TOPICAL ANESTHETIC- benzocaine gel 
Benco Dental

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

Benzocaine 200 mg (in each g)

Purpose

Oral Anesthetic

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

Warnings

Warnings
Methemoglolllnemla
warning: Use of this product
may cause methemoglobinemia,
a seriouscondit~n that must be
treated promptly because tt
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

• shortness of breath
• dizziness or lightheadedness
• fatigue or lack of energy

Allergy Alert

Allergy Alert Do not use on
patients with a history of
allergies to local anesthetics
suchasprocaine,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 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.

Keep out of reach of children

Directions

• Apply only amount needed to
the oral mucosa to prevent or
relieve pain.
• children under 2 years of age:
do not use

Other Information

Store at 59 -86°F(15-30°C).
Protect from freezing.

Inactive Ingredients

flavoring, PEG 3350, PEG 400, sodium saccharin.

Questions or Comments?

800.GO.BENCO or benco.com

Bencocaine Topical Wrap_dye-free_99091791

BENCOCAINE TOPICAL ANESTHETIC 
benzocaine gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:66975-340
Route of AdministrationDENTAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BENZOCAINE (UNII: U3RSY48JW5) (BENZOCAINE - UNII:U3RSY48JW5) BENZOCAINE200 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
POLYETHYLENE GLYCOL 3350 (UNII: G2M7P15E5P)  
SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
Product Characteristics
Colorwhite (DYE-FREE) Score    
ShapeSize
FlavorCHERRYImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:66975-340-3030 g in 1 JAR; Type 0: Not a Combination Product10/01/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35610/01/2020
Labeler - Benco Dental (015108087)

Revised: 9/2023
Document Id: 05cf428c-3bc9-5fcb-e063-6394a90a962a
Set id: 05cf428c-3bc8-5fcb-e063-6394a90a962a
Version: 1
Effective Time: 20230920
 
Benco Dental