ANBESOL  MAXIMUM STRENGTH- benzocaine solution 
Foundation Consumer Brands

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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Anbesol®
Maximum Strength

Drug Facts

Active ingredient

Benzocaine 20%

Purpose

Oral pain reliever

Uses

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 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 2 years of age

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 lasts 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

adults and children 2 years of age and overwipe 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 between 2 and 12 years of ageshould be supervised in the use of this product
children under 2 years of agedo not use

Other information

store at 20-25°C (68-77°F)

Inactive ingredients

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

Questions or comments?

Call 1-888-594-0673 weekdays 9 AM to 5 PM EST

Distributed by: Foundation Consumer Brands, LLC
Pittsburgh, PA 15212

PRINCIPAL DISPLAY PANEL - 12 mL Bottle Blister Pack

MAXIMUM
STRENGTH

20%
BENZOCAINE

ANBESOL®

ORAL PAIN RELIEVER |
BENZOCAINE 20%

INSTANT ORAL
PAIN RELIEF

ADA
Accepted
American
Dental
Association ®

TOOTHACHES
CANKER SORES
ALIGNER PAIN
GUM PAIN

LIQUID

0.41 FL OZ (12 mL)

PRINCIPAL DISPLAY PANEL - 12 mL Bottle Blister Pack
ANBESOL   MAXIMUM STRENGTH
benzocaine solution
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:80070-230
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:80070-230-411 in 1 BLISTER PACK09/15/2021
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 FINALpart35609/15/2021
Labeler - Foundation Consumer Brands (117603632)

Revised: 7/2023
Document Id: 4d9d7dc5-dbee-437f-bd07-afcd5add7dc4
Set id: 8c6ac499-9bd2-4ea5-9f26-df7947bff4a6
Version: 2
Effective Time: 20230725
 
Foundation Consumer Brands