BABY ANBESOL- benzocaine gel
Wyeth Consumer Healthcare LLC

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.

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

BABY ANBESOL
benzocaine gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:0573-0216
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
BENZOCAINE (UNII: U3RSY48JW5) (BENZOCAINE - UNII:U3RSY48JW5)	BENZOCAINE	75 mg in 1 g

Ingredient Name	Strength
Inactive Ingredients
BENZOIC ACID (UNII: 8SKN0B0MIM)
CARBOMER HOMOPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: HHT01ZNK31)
D&C RED NO. 33 (UNII: 9DBA0SBB0L)
EDETATE DISODIUM (UNII: 7FLD91C86K)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
GLYCERIN (UNII: PDC6A3C0OX)
METHYLPARABEN (UNII: A2I8C7HI9T)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
SACCHARIN (UNII: FST467XS7D)
WATER (UNII: 059QF0KO0R)

Product Characteristics
Color	PURPLE (translucent purple soft gel)	Score
Shape		Size
Flavor	GRAPE	Imprint Code
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:0573-0216-25	1 in 1 BLISTER PACK	04/01/2004	07/31/2014
1		9 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC MONOGRAPH FINAL	part348	04/01/2004	07/31/2014

Labeler - Wyeth Consumer Healthcare LLC (828831730)

Revised: 10/2017

Document Id: 56db611d-b6e7-40b1-a187-85f388a3f0eb

Set id: 930ffc21-37d4-5b82-708a-e02d8251a86d

Version: 6

Effective Time: 20171004

Wyeth Consumer Healthcare LLC