CVS FAST ACTING BABY TEETHING- benzocaine gel

CVS Fast Acting Baby Teething by

Drug Labeling and Warnings

CVS Fast Acting Baby Teething by is a Otc medication manufactured, distributed, or labeled by CVS Pharmacy, Pharma Pac, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active ingredient                                 Purpose

Benzocaine 10%............................................Oral Pain Reliever

PURPOSE

Uses

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

KEEP OUT OF REACH OF CHILDREN

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

INDICATIONS & USAGE

Uses

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

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

WARNINGS

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

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

DOSAGE & ADMINISTRATION

Directions 

- wash hands - cut open tip of tube on score mark
- use your fingertip or cotton swab to apply a small, pea-size amount of product
- apply to the affected area up to four times daily or as directed by a dentist or doctor
- for infants under 4 months of age, ask a dentist or doctor

Other information

do not use if tube tip is cut prior to opening

INACTIVE INGREDIENT

Inactive Ingredients

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

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

CVS FAST ACTING BABY TEETHING 
benzocaine gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 59779-829
Route of Administration	ORAL

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

Inactive Ingredients
Ingredient Name	Strength
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
Shape		Size
Flavor	CHERRY (CHERRY FLAVOR)	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 59779-829-53	1 in 1 CARTON
1		9.4 g in 1 TUBE, WITH APPLICATOR

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part346	07/08/2010

Labeler - CVS Pharmacy (062312574)

Registrant - Pharma Pac, LLC (140807475)

Establishment
Name	Address	ID/FEI	Business Operations
Pharma Pac, LLC		140807475	manufacture