CVS FAST ACTING BABY TEETHING - benzocaine gel 
CVS Pharmacy

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.

----------

drug facts

Active ingredient                                 Purpose

Benzocaine 7.5%............................................Oral Pain Reliever



Uses

- temporary relief of sore gums due to teething in infants and children 4 months and older


Keep out of reach of children. If case of allergic reaction or overdose, seek medical attention or contact
a Poison Control Center immediately.

Uses

- temporary relief of sore gums due to teething in infants and children 4 months or older
 

Other information
- do not use if tube tip is cut prior to opening

Warnings

Allergy alert:
do not use this product if your baby has a history of allergy to
local anesthetics such as butacaine, benzocaine, procaine, or other "caine" anesthetics

Do not use
- more than directed - for more than 7 days, unless directed by a dentist or doctor

When using this product - fever and nasal congestion are not symptoms of teething
and may indicate the presence of infection. if these symptoms persist, contact your dentist or doctor.

Stop use and consult a dentist or doctor if:

- sore gum symptoms do not get better in 7 days
- irritation, pain or redness does not go away - rash, swelling or fever develops

Keep out of the reach of children. In case of allergic reaction or overdose,
seek medical attention or contact a Poison Control Center immediately.


Directions 

- clean hands thoroughly - cut open tip of tube on score line
- use your fingertip or cotton swab to apply a small, pea-size amount of CVS Baby Teething Gel
- apply to the affected area up to four times a day or as directed by a dentist or doctor
- consult a dentist or doctor for infants under 4 months of age

Other information

do not use if tube tip is cut prior to opening

Inactive Ingredients

FD and C red no. 4, flavor, glycerin, propylene glycols, purified water, sodium saccharine, sorbic acid, sorbitol


c


CVS FAST ACTING BABY TEETHING 
benzocaine gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59779-829
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BENZOCAINE (UNII: U3RSY48JW5) (BENZOCAINE - UNII:U3RSY48JW5) BENZOCAINE75 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
GLYCERIN (UNII: PDC6A3C0OX)  
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
POLYETHYLENE GLYCOL 1450 (UNII: OJ4Z5Z32L4)  
SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
SORBITOL (UNII: 506T60A25R)  
FD&C RED NO. 4 (UNII: X3W0AM1JLX)  
WATER (UNII: 059QF0KO0R)  
SORBIC ACID (UNII: X045WJ989B)  
Product Characteristics
Color    Score    
ShapeSize
FlavorCHERRY (CHERRY FLAVOR) Imprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:59779-829-511 in 1 CARTON
19.4 g in 1 TUBE, WITH APPLICATOR
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34607/08/2010
Labeler - CVS Pharmacy (062312574)
Registrant - Pharma Pac, LLC (140807475)
Establishment
NameAddressID/FEIBusiness Operations
Pharma Pac, LLC140807475manufacture

Revised: 7/2010
Document Id: e0ba65c6-5dc4-4b1c-95f4-a3b815fc5c14
Set id: b04e30a9-b5c8-4d80-903f-4ee233384610
Version: 1
Effective Time: 20100708
 
CVS Pharmacy