ANBESOL REGULAR STRENGTH- benzocaine gel 
ANBESOL REGULAR STRENGTH- benzocaine solution 
ANBESOL MAXIMUM STRENGTH- benzocaine gel 
ANBESOL MAXIMUM STRENGTH- benzocaine solution 
GlaxoSmithKline Consumer Healthcare Holdings (US) LLC

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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Drug Facts

ACTIVE INGREDIENT

Anbesol Regular Strength Cool Mint Liquid and Gel

Benzocaine 10%

Anbesol Maximum Strength Liquid and Gel

Benzocaine 20%

PURPOSE

Oral Anesthetic

USES

temporarily relieves pain associated with the following mouth and gum irritations:
toothache
sore gums
canker sores
braces
minor dental procedures
dentures

WARNINGS

METHEMOGLOBINEMIA WARNING

Use of this product may cause methemoglobinemia, a serious condition that must be treated promptly because it 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
rapid heart rate
shortness of breath
dizziness or lightheadedness
fatigue or lack of energy

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

for teething
in children under age 2

When using this product

avoid contact with the eyes
do not exceed recommended dosage
do not use for more than 7 days unless directed by a doctor/dentist

Stop use and ask a doctor if

sore mouth symptoms do not improve in 7 days
irritation, pain, or redness persists or worsens
swelling, rash, or fever develops

Keep out of reach of children.

If more than used for pain is accidentally swallowed, get medical help or contact a Poison Control Center right away.

DIRECTIONS

Anbesol Regular Strength Cool Mint and Maximum Strength Liquid

adults and children 2 years of age and older:
wipe liquid on with cotton, or cotton swab, or fingertip
apply to the affected area up to 4 times daily or as directed by a doctor/dentist
children under 12 years of age: adult supervision should be given in the use of this product
children under 2 years of age: do not use

Anbesol Regular Strength Cool Mint and Maximum Strength Gel

to open tube, cut tip of the tube on score mark with scissors
adults and children 2 years of age and older: apply a pea-size amount to the affected area up to 4 times daily or as directed by a doctor/dentist
children under 12 years of age: adult supervision should be given in the use of this product
children under 2 years of age: do not use
for denture irritation:
apply thin layer to the affected area
do not reinsert dental work until irritation/pain is relieved
rinse mouth well before reinserting

OTHER INFORMATION

Anbesol Regular Strength Cool Mint Liquid and Gel and Anbesol Maximum Strength Liquid

Store at 20-25°C (68-77°F)

Anbesol Maximum Strength Gel

Store at 20-25°C (68-77°F). Do not refrigerate.

INACTIVE INGREDIENTS

Anbesol Regular Strength Cool Mint Liquid

benzyl alcohol, D&C red no. 33, D&C yellow no. 10, FD&C blue no. 1, FD&C yellow no. 6, methylparaben, natural and artificial flavors, polyethylene glycol, propylene glycol, saccharin

Anbesol Regular Strength Cool Mint Gel

benzyl alcohol, carbomer 934P, D&C red no. 33, D&C yellow no. 10, FD&C blue no. 1, FD&C yellow no. 6, glycerin, methylparaben, natural and artificial flavor, polyethylene glycol, propylene glycol, saccharin

Anbesol Maximum Strength Liquid

benzyl alcohol, D&C yellow no. 10, FD&C blue no. 1, FD&C red no. 40, methylparaben, natural flavor, polyethylene glycol, polysorbate 80, propylene glycol, saccharin

Anbesol Maximum Strength Gel

benzyl alcohol, carbomer 934P, D&C yellow no. 10, FD&C blue no. 1, FD&C red no. 40, glycerin, methylparaben, natural flavor, polyethylene glycol, polysorbate 80, propylene glycol, saccharin

PRODUCT PACKAGING

The product packaging shown below represents a sample of that currently in use. Additional packaging may also be available.

PRINCIPAL DISPLAY PANEL - 9 g Tube Blister Pack - 10%

cool mint
gel

See new warnings information

Anbesol®
Oral Anesthetic/Benzocaine 10%

REGULAR
STRENGTH

DOCTOR
RECOMMENDED

Instant
Pain Relief

Toothaches
Gum Pain
Canker Sores
Denture Pain

NET WT 0.33 OZ (9 g)

Safety Sealed Tube:
Do Not Use if tube tip is cut prior to opening.

PRINCIPAL DISPLAY PANEL - 9 g Tube Blister Pack - 10%

PRINCIPAL DISPLAY PANEL - 12 ml Bottle Blister Pack - 10%

cool mint
liquid

See new warnings information

Anbesol®
Oral Anesthetic/Benzocaine 10%

REGULAR
STRENGTH

DOCTOR
RECOMMENDED

Instant
Pain Relief

Toothaches
Gum Pain
Canker Sores
Denture Pain

NET WT 0.41 FL OZ (12 ml)

Do Not Use if plastic blister or backing material is broken
or if backing material is separated from the plastic.

Principal Display Panel - 12 ml Bottle Blister Pack - 10%

PRINCIPAL DISPLAY PANEL - 9 g Tube Blister Pack - 20%

gel

See new warnings information

Anbesol®
Oral Anesthetic/Benzocaine 20%

MAXIMUM
STRENGTH

DOCTOR
RECOMMENDED

Instant
Pain Relief

Toothaches
Gum Pain
Canker Sores
Denture Pain

NET WT 0.33 OZ (9 g)

Safety Sealed Tube:
Do Not Use if tube tip is cut prior to opening.

PRINCIPAL DISPLAY PANEL - 9 g Tube Blister Pack - 20%

PRINCIPAL DISPLAY PANEL - 12 ml Bottle Blister Pack - 20%

liquid

See new warnings information

Anbesol®
Oral Anesthetic/Benzocaine 20%

MAXIMUM
STRENGTH

DOCTOR
RECOMMENDED

Instant
Pain Relief

Toothaches
Gum Pain
Canker Sores
Denture Pain

NET WT 0.41 FL OZ (12 ml)

Do Not Use if plastic blister or backing material is broken
or if backing material is separated from the plastic.

Principal Display Panel - 12 ml Bottle Blister Pack - 20%
ANBESOL REGULAR STRENGTH 
benzocaine gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0573-0218
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BENZOCAINE (UNII: U3RSY48JW5) (BENZOCAINE - UNII:U3RSY48JW5) BENZOCAINE100 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
BENZYL ALCOHOL (UNII: LKG8494WBH)  
CARBOMER HOMOPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: HHT01ZNK31)  
D&C RED NO. 33 (UNII: 9DBA0SBB0L)  
D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
GLYCERIN (UNII: PDC6A3C0OX)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
SACCHARIN (UNII: FST467XS7D)  
Product Characteristics
ColorYELLOWScore    
ShapeSize
FlavorSPEARMINTImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0573-0218-251 in 1 BLISTER PACK05/11/200504/16/2010
19 g in 1 TUBE; Type 0: Not a Combination Product
2NDC:0573-0218-261 in 1 BLISTER PACK09/15/200806/30/2021
29 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35605/11/200506/30/2021
ANBESOL REGULAR STRENGTH 
benzocaine solution
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0573-0213
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BENZOCAINE (UNII: U3RSY48JW5) (BENZOCAINE - UNII:U3RSY48JW5) BENZOCAINE100 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
BENZYL ALCOHOL (UNII: LKG8494WBH)  
D&C RED NO. 33 (UNII: 9DBA0SBB0L)  
D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
SACCHARIN (UNII: FST467XS7D)  
Product Characteristics
ColorYELLOWScore    
ShapeSize
FlavorSPEARMINTImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0573-0213-411 in 1 BLISTER PACK05/11/200506/30/2021
112 mL in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35605/11/200506/30/2021
ANBESOL MAXIMUM STRENGTH 
benzocaine gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0573-0225
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BENZOCAINE (UNII: U3RSY48JW5) (BENZOCAINE - UNII:U3RSY48JW5) BENZOCAINE200 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
BENZYL ALCOHOL (UNII: LKG8494WBH)  
CARBOMER HOMOPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: HHT01ZNK31)  
D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
FD&C RED NO. 40 (UNII: WZB9127XOA)  
GLYCERIN (UNII: PDC6A3C0OX)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
SACCHARIN (UNII: FST467XS7D)  
Product Characteristics
ColorBROWNScore    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0573-0225-671 in 1 BLISTER PACK05/11/200506/30/2021
19 g in 1 TUBE; Type 0: Not a Combination Product
2NDC:0573-0225-011500 in 1 CASE05/11/200509/30/2015
20.375 g in 1 POUCH; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35605/11/200506/30/2021
ANBESOL MAXIMUM STRENGTH 
benzocaine solution
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0573-0215
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BENZOCAINE (UNII: U3RSY48JW5) (BENZOCAINE - UNII:U3RSY48JW5) BENZOCAINE200 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
BENZYL ALCOHOL (UNII: LKG8494WBH)  
D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
FD&C RED NO. 40 (UNII: WZB9127XOA)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
SACCHARIN (UNII: FST467XS7D)  
Product Characteristics
ColorBROWNScore    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0573-0215-411 in 1 BLISTER PACK05/11/200506/30/2021
112 mL in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35605/11/200506/30/2021
Labeler - GlaxoSmithKline Consumer Healthcare Holdings (US) LLC (079944263)

Revised: 1/2022
 
GlaxoSmithKline Consumer Healthcare Holdings (US) LLC