ANBESOL MAXIMUM STRENGTH- benzocaine gel 
Foundation Consumer Brands

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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

Other information

Inactive ingredients

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

Questions or comments?

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

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

PRINCIPAL DISPLAY PANEL - 9 g Tube Blister Pack

MAXIMUM STRENGTH

20% Benzocaine

Anbesol ®
Oral Pain Reliever/Benzocaine 20%

Instant Oral
Pain Relief

ADA Accepted

American Dental Association

GEL

NET WT 0.33 OZ (9 g)

anbesol label

ANBESOL  MAXIMUM STRENGTH
benzocaine gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:80070-220
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 OR ALLYL SUCROSE CROSSLINKED) (UNII: K6MOM3T5YL)  
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:80070-220-331 in 1 BLISTER PACK09/15/2021
19 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM02209/15/2021
Labeler - Foundation Consumer Brands (117603632)

Revised: 11/2024
Document Id: 2645b186-a089-1998-e063-6394a90ae9ca
Set id: dcc37403-0192-4658-bb7a-059273ce0047
Version: 3
Effective Time: 20241106
 
Foundation Consumer Brands