ANBESOL REGULAR STRENGTH- benzocaine gel ANBESOL REGULAR STRENGTH- benzocaine solution ANBESOL MAXIMUM STRENGTH- benzocaine gel

ANBESOL MAXIMUM STRENGTH by

Drug Labeling and Warnings

ANBESOL MAXIMUM STRENGTH by is a Otc medication manufactured, distributed, or labeled by GlaxoSmithKline Consumer Healthcare Holdings (US) LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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 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

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 - 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

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.

INGREDIENTS AND APPEARANCE

ANBESOL REGULAR STRENGTH 
benzocaine gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0573-0218
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BENZOCAINE (UNII: U3RSY48JW5) (BENZOCAINE - UNII:U3RSY48JW5)	BENZOCAINE	100 mg  in 1 g

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

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0573-0218-25	1 in 1 BLISTER PACK	05/11/2005	04/16/2010
1		9 g in 1 TUBE; Type 0: Not a Combination Product
2	NDC: 0573-0218-26	1 in 1 BLISTER PACK	09/15/2008
2		9 g in 1 TUBE; 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	05/11/2005

ANBESOL REGULAR STRENGTH 
benzocaine solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0573-0213
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BENZOCAINE (UNII: U3RSY48JW5) (BENZOCAINE - UNII:U3RSY48JW5)	BENZOCAINE	100 mg  in 1 mL

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

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0573-0213-41	1 in 1 BLISTER PACK	05/11/2005
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	05/11/2005

ANBESOL MAXIMUM STRENGTH 
benzocaine gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0573-0225
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 g

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

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0573-0225-67	1 in 1 BLISTER PACK	05/11/2005
1		9 g in 1 TUBE; Type 0: Not a Combination Product
2	NDC: 0573-0225-01	1500 in 1 CASE	05/11/2005	09/30/2015
2		0.375 g in 1 POUCH; 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	05/11/2005

ANBESOL MAXIMUM STRENGTH 
benzocaine solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0573-0215
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: 0573-0215-41	1 in 1 BLISTER PACK	05/11/2005
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	05/11/2005

Labeler - Wyeth Consumer Healthcare LLC (828831730)