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Name:Anbesol Jr
Manufacturer:Wyeth Consumer Healthcare
Category:Over-the-counter (OTC) Marketed Drugs


Anbesol (benzocaine)

ANBESOL JR - benzocaine gel 
ANBESOL REGULAR STRENGTH GEL - benzocaine gel 
ANBESOL REGULAR STRENGTH LIQUID - benzocaine liquid 
ANBESOL MAXIMUM STRENGTH GEL - benzocaine gel 
ANBESOL MAXIMUM STRENGTH LIQUID - benzocaine liquid 
Wyeth Consumer Healthcare

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 (benzocaine)

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 Regular Strength Packaging

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 Jr. Packaging

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

Anbesol Maximum Strength Packaging

ANBESOL JR 
benzocaine gel
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:0573-0223
Route of Administration TOPICAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
benzocaine (benzocaine) benzocaine 100 mg  in 1 g
Product Characteristics
Color      Score     
Shape Size
Flavor Imprint Code
Contains     
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0573-0223-67 1 TUBE ( TUBE) in 1 BLISTER PACK contains a TUBE
1 9 g in 1 TUBE This package is contained within the BLISTER PACK (0573-0223-67)

Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph final part356 05/11/2005

ANBESOL REGULAR STRENGTH GEL 
benzocaine gel
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:0573-0218
Route of Administration TOPICAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
benzocaine (benzocaine) benzocaine 100 mg  in 1 g
Product Characteristics
Color      Score     
Shape Size
Flavor Imprint Code
Contains     
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0573-0218-25 1 TUBE ( TUBE) in 1 BLISTER PACK contains a TUBE
1 9 g in 1 TUBE This package is contained within the BLISTER PACK (0573-0218-25)

Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph final part356 05/11/2005

ANBESOL REGULAR STRENGTH LIQUID 
benzocaine liquid
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:0573-0213
Route of Administration TOPICAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
benzocaine (benzocaine) benzocaine 100 mg  in 1 mL
Product Characteristics
Color      Score     
Shape Size
Flavor Imprint Code
Contains     
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0573-0213-41 1 BOTTLE ( BOTTLE) in 1 BLISTER PACK contains a BOTTLE
1 12 mL in 1 BOTTLE This package is contained within the BLISTER PACK (0573-0213-41)

Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph final part356 05/11/2004

ANBESOL MAXIMUM STRENGTH GEL 
benzocaine gel
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:0573-0225
Route of Administration TOPICAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
benzocaine (benzocaine) benzocaine 200 mg  in 1 g
Product Characteristics
Color      Score     
Shape Size
Flavor Imprint Code
Contains     
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0573-0225-67 1 TUBE ( TUBE) in 1 BLISTER PACK contains a TUBE
1 9 g in 1 TUBE This package is contained within the BLISTER PACK (0573-0225-67)

Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph final part356 05/11/2005

ANBESOL MAXIMUM STRENGTH LIQUID 
benzocaine liquid
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:0573-0215
Route of Administration TOPICAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
benzocaine (benzocaine) benzocaine 200 mg  in 1 mL
Product Characteristics
Color      Score     
Shape Size
Flavor Imprint Code
Contains     
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0573-0215-41 1 BOTTLE ( BOTTLE) in 1 BLISTER PACK contains a BOTTLE
1 12 mL in 1 BOTTLE This package is contained within the BLISTER PACK (0573-0215-41)

Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph final part356 05/11/2005

Labeler - Wyeth Consumer Healthcare (828831730)

Revised: 06/2009 Wyeth Consumer Healthcare



Source: http://dailymed.nlm.nih.gov
Reproduced with permission of U.S. National Library of Medicine


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