ANBESOL JR

Wyeth Consumer Healthcare

Anbesol (benzocaine)

FULL PRESCRIBING INFORMATION: CONTENTS*

• DRUG FACTS
• ACTIVE INGREDIENT
  • Anbesol Regular Strength Liquid and Gel
  • Anbesol Jr. Gel
  • Anbesol Maximum Strength Liquid and Gel
• PURPOSE
• USES
• WARNINGS
  • Allergy alert
  • When using this product
  • Stop use and ask a doctor if
  • Keep out of reach of children.
• DIRECTIONS
  • Anbesol Regular and Maximum Strength Liquid
  • Anbesol Regular and Maximum Strength Gel
  • Anbesol Jr. Gel
• OTHER INFORMATION
  • Anbesol Regular Strength Liquid and Gel, Anbesol Maximum Strength Liquid, and Anbesol Jr. Gel
  • Anbesol Maximum Strength Gel
• INACTIVE INGREDIENTS
  • Anbesol Regular Strength Liquid
  • Anbesol Regular Strength Gel
  • Anbesol Jr. Gel
  • Anbesol Maximum Strength Liquid
  • Anbesol Maximum Strength Gel
• PRODUCT PACKAGING
  • Anbesol Regular Strength Liquid
• ANBESOL JR GEL
  • Anbesol Maximum Strength Gel

FULL PRESCRIBING INFORMATION

DRUG FACTS

ACTIVE INGREDIENT

Anbesol Regular Strength Liquid and Gel

Benzocaine 10%

Anbesol Jr. 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

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 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 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 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

Anbesol Jr. Gel

• to open tube, cut tip of the tube on score mark with scissors
• adults and children 2 years of age and older: 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

OTHER INFORMATION

Anbesol Regular Strength Liquid and Gel, Anbesol Maximum Strength Liquid, and Anbesol Jr. Gel

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 Liquid

benzyl alcohol, D&C red no. 33, D&C yellow no. 10, FD&C blue no. 1, FD&C yellow no. 6, flavor, methylparaben, polyethylene glycol, propylene glycol, saccharin

Anbesol Regular Strength 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, flavor, glycerin, methylparaben, polyethylene glycol, propylene glycol, saccharin

Anbesol Jr. Gel

artificial flavor, benzyl alcohol, carbomer 934P, D&C red no. 33, glycerin, methylparaben, polyethylene glycol, potassium acesulfame

Anbesol Maximum Strength Liquid

benzyl alcohol, D&C yellow no. 10, FD&C blue no. 1, FD&C red no. 40, flavor, methylparaben, polyethylene glycol, 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, flavor, glycerin, methylparaben, polyethylene glycol, propylene glycol, saccharin

PRODUCT PACKAGING

The product packaging shown below represents a sample of that currently in use. Additional packaging may also be available.

Anbesol Regular Strength Liquid

Anbesol

Oral Anesthetic/Benzocaine 10%

Regular Strength

Doctor Recommended

Cool Mint Liquid

Instant Pain Relief

• Toothaches
• Gum Pain
• Canker Sores
• Denture Pain

NET WT .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.

Visit us at anbesol.com

Wyeth Consumer Healthcare, Madison, NJ 07940 ©2007 Made in USA

ANBESOL JR GEL

Anbesol Jr.

Oral Anesthetic/Benzocaine 10%

For Kids and Teens

Doctor Recommended

Bubble Gum Flavor Gel

Instant Brace Pain Relief

• Brace Pain
• Gum Pain
• Canker Sores
• Toothaches

NET WT .33 OZ (9 g)

Safety sealed tube:

Do Not Use if tube tip is cut prior to opening.

Visit us at anbesol.com

Wyeth Consumer Healthcare, Madison, NJ 07940 ©2007 Made in USA

Anbesol Maximum Strength Gel

Anbesol

Oral Anesthetic/Benzocaine 20%

Maximum Strength

Gel

Doctor Recommended

Instant pain relief

• Toothaches
• Gum pain
• Canker sores
• Denture pain

NET WT .33 OZ (9 g)

Safety sealed tube:

Do Not Use if tube tip is cut prior to opening.

Visit us at anbesol.com

Wyeth Consumer Healthcare, Madison, NJ 07940 ©2007 Made in USA