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


Anbesol Baby (benzocaine)

BABY ANBESOL - benzocaine gel 
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 Baby (benzocaine)

DRUG FACTS

ACTIVE INGREDIENT

Benzocaine 7.5%

PURPOSE

Oral Anesthetic

USE

temporarily relieves sore gums due to teething in infants and children 4 months of age and older

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.

Do not use

to treat fever and nasal congenstion. These are not symptoms of teething and may indicate the presence of infection. If these symptoms persist, consult your doctor.

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

  • to open tube, cut tip of the tube on score mark with scissors
  • children 4 months of age and older: apply to the affected area not more than 4 times daily or as directed by a doctor/dentist
  • infants under 4 months of age: no recommended dosage or treatment except under the advice and supervision of a doctor/dentist.

OTHER INFORMATION

store at 20-25°C (68-77°F)

INACTIVE INGREDIENTS

artificial flavor, benzoic acid, carbomer 934P, D&C red no. 33, edetate disodium, FD&C blue no. 1, glycerin, methylparaben, polyethylene glycol, propylparaben, purified water, saccharin

QUESTIONS OR COMMENTS?

Call weekdays 9AM to 5PM EST at 1-888-797-5638

PRODUCT PACKAGING

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

Anbesol Baby

Benzocaine 7.5%/Oral Anesthetic

Grape gel

Instant Teething Pain Relief

  • Works on Contact
  • Alcohol-Free

NET WT 0.33 OZ (9g)

Safety Sealed Tube:

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

Wyeth Consumer Healthcare, Madison, NJ 07940 USA ©2009 Wyeth

For most recent product information, visit www.anbesol.com

Anbesol Baby Packaging

BABY ANBESOL 
benzocaine gel
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:0573-0216
Route of Administration TOPICAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
benzocaine (benzocaine) benzocaine 75 mg  in 1 g
Product Characteristics
Color PURPLE (translucent purple soft gel) Score     
Shape Size
Flavor GRAPE Imprint Code
Contains     
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0573-0216-25 1 TUBE ( TUBE) in 1 BLISTER PACK contains a TUBE
1 9 g in 1 TUBE This package is contained within the BLISTER PACK (0573-0216-25)

Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph final part356 04/01/2004

Labeler - Wyeth Consumer Healthcare (828831730)
Establishment
Name Address ID/FEI Operations
Richmond Division of Wyeth 829390827 MANUFACTURE, ANALYSIS

Revised: 02/2010 Wyeth Consumer Healthcare



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


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