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ANBESOL JR

Medically reviewed on September 27, 2017

Dosage form: gel
Ingredients: BENZOCAINE 100mg in 1g
Labeler: Wyeth Consumer Healthcare LLC
NDC Code: 0573-0223

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.

Anbesol (benzocaine)

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 rare but serious condition that must be treated promptly because it reduces the amount of oxygen carried in the blood. 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

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: consult a doctor/dentist

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: consult a doctor/dentist
  • 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 - Anbesol Jr. Gel

bubble
gum

FLAVOR
gel

Anbesol
JR.
®
For kids
& teens

Oral Anesthetic/
Benzocaine 10%

DOCTOR
RECOMMENDED

Instant
Brace Pain Relief

Brace Pain
Gum Pain
Canker Sores
Toothaches

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 Label - 10%

cool mint
gel

Anbesol®
Oral Anesthetic/
Benzocaine 10%

REGULAR STRENGTH

NET WT
0.33 OZ
(9 g)

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 - 12 ml Bottle Label - 10%

cool mint liquid

Anbesol®
Oral Anesthetic/Benzocaine 10%

REGULAR
STRENGTH

DOCTOR
RECOMMENDED

NET WT
0.41 FL OZ
(12 ml)

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

cool mint
liquid

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 - 9 g Tube Label - 20%

gel

Anbesol®
Oral Anesthetic/
Benzocaine 20%

MAXIMUM STRENGTH

NET WT
0.33 OZ
(9 g)

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 - 12 ml Bottle Label - 20%

liquid

Anbesol®
Oral Anesthetic/Benzocaine 20%

MAXIMUM
STRENGTH

DOCTOR
RECOMMENDED

NET WT
0.41 FL OZ
(12 ml)

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

liquid

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.

ANBESOL JR 
benzocaine gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0573-0223
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BENZOCAINE (BENZOCAINE) BENZOCAINE100 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
ACESULFAME POTASSIUM 
BENZYL ALCOHOL 
CARBOMER HOMOPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED) 
D&C RED NO. 33 
FD&C RED NO. 40 
METHYLPARABEN 
POLYETHYLENE GLYCOL, UNSPECIFIED 
Product Characteristics
ColorPINKScore    
ShapeSize
FlavorBUBBLE GUMImprint Code
Contains    
Packaging
#Item CodePackage Description
1NDC:0573-0223-671 TUBE in 1 BLISTER PACK
19 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart35605/11/200508/31/2014
ANBESOL REGULAR STRENGTH 
benzocaine gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0573-0218
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BENZOCAINE (BENZOCAINE) BENZOCAINE100 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
BENZYL ALCOHOL 
CARBOMER HOMOPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED) 
D&C RED NO. 33 
D&C YELLOW NO. 10 
FD&C BLUE NO. 1 
FD&C YELLOW NO. 6 
GLYCERIN 
METHYLPARABEN 
PROPYLENE GLYCOL 
SACCHARIN 
Product Characteristics
ColorYELLOWScore    
ShapeSize
FlavorSPEARMINTImprint Code
Contains    
Packaging
#Item CodePackage Description
1NDC:0573-0218-251 TUBE in 1 BLISTER PACK
19 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart35605/11/2005
ANBESOL REGULAR STRENGTH 
benzocaine solution
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0573-0213
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BENZOCAINE (BENZOCAINE) BENZOCAINE100 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
BENZYL ALCOHOL 
D&C RED NO. 33 
D&C YELLOW NO. 10 
FD&C BLUE NO. 1 
FD&C YELLOW NO. 6 
METHYLPARABEN 
POLYETHYLENE GLYCOL, UNSPECIFIED 
PROPYLENE GLYCOL 
SACCHARIN 
Product Characteristics
ColorYELLOWScore    
ShapeSize
FlavorSPEARMINTImprint Code
Contains    
Packaging
#Item CodePackage Description
1NDC:0573-0213-411 BOTTLE in 1 BLISTER PACK
112 mL in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart35605/11/2005
ANBESOL MAXIMUM STRENGTH 
benzocaine gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0573-0225
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BENZOCAINE (BENZOCAINE) BENZOCAINE200 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
BENZYL ALCOHOL 
CARBOMER HOMOPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED) 
D&C YELLOW NO. 10 
FD&C BLUE NO. 1 
FD&C RED NO. 40 
GLYCERIN 
METHYLPARABEN 
POLYETHYLENE GLYCOL, UNSPECIFIED 
POLYSORBATE 80 
PROPYLENE GLYCOL 
SACCHARIN 
Product Characteristics
ColorBROWNScore    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage Description
1NDC:0573-0225-671 TUBE in 1 BLISTER PACK
19 g in 1 TUBE
2NDC:0573-0225-011500 POUCH in 1 CASE
20.375 g in 1 POUCH
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart35605/11/2005
ANBESOL MAXIMUM STRENGTH 
benzocaine solution
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0573-0215
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BENZOCAINE (BENZOCAINE) BENZOCAINE200 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
BENZYL ALCOHOL 
D&C YELLOW NO. 10 
FD&C BLUE NO. 1 
FD&C RED NO. 40 
METHYLPARABEN 
POLYETHYLENE GLYCOL, UNSPECIFIED 
POLYSORBATE 80 
PROPYLENE GLYCOL 
SACCHARIN 
Product Characteristics
ColorBROWNScore    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage Description
1NDC:0573-0215-411 BOTTLE in 1 BLISTER PACK
112 mL in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart35605/11/2005
Labeler - Wyeth Consumer Healthcare LLC (828831730)

 
Wyeth Consumer Healthcare LLC

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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