ANBESOL MAXIMUM STRENGTH- benzocaine solution

Anbesol by

Drug Labeling and Warnings

Anbesol by is a Otc medication manufactured, distributed, or labeled by Foundation Consumer Brands. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient

Benzocaine 20%

Purpose

Oral pain reliever

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 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 over: 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 between 2 and 12 years of age: should be supervised 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

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

SPL UNCLASSIFIED SECTION

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)

INGREDIENTS AND APPEARANCE

ANBESOL   MAXIMUM STRENGTH
benzocaine solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 80070-230
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BENZOCAINE (UNII: U3RSY48JW5) (BENZOCAINE - UNII:U3RSY48JW5)	BENZOCAINE	200 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
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
Color	BROWN	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 80070-230-41	1 in 1 BLISTER PACK	09/15/2021
1		12 mL in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH NOT FINAL	part356	09/15/2021

Labeler - Foundation Consumer Brands (117603632)