CVS PHARMACY MAXIMUM STRENGTH- benzocaine liquid

CVS Pharmacy by

Drug Labeling and Warnings

CVS Pharmacy by is a Otc medication manufactured, distributed, or labeled by CVS Pharmacy, Lornamead Inc., CSR Cosmetic Solutions Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active ingredient

Benzocaine 20% (w/w)

PURPOSE

Purpose

Oral Anesthetic

INDICATIONS & USAGE

Uses

temporarily relieves pain associated with the following mouth irritations

• toothache
• sore gums
• canker sores
• braces
• minor dental procedures

WARNINGS

Warnings

Methemoglobinemia warning: use of this product may cause methemoglobinemia, a serious condition that must be treated promptly because it reduces the amount of oxygen carried in blood. This can occur even if you have used this product before. Stop use and seek immediate medical attention if you or a child in your care develops:

• pale, gray, or blue colored skin (cyanosis)
• headache
• rapid heart rate
• shortness of breath
• dizziness or lightheadedness
• fatigue or lack of energy

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

• more than directed
• for more than 7 days unless directed by a dentist or doctor
• for teething
• in children under 2 years of age

Stop use and ask a doctor if

• swelling rash or fever develops
• irritation, pain or redness persists or worsens
• symptoms do not improve in 7 days
• allergic reaction occurs

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

DOSAGE & ADMINISTRATION

Directions

Adults and children 2 years of age and older:

• apply to affected area using applicator tip
• use up to 4 times daily or as directed by a dentist or doctor.
• children under 12 years of age should be supervised in the use of this product.

Children under 2 years of age: do not use

STORAGE AND HANDLING

Other information

• do not use if package has been opened
• store at 20-25°C (68-77°F)

INACTIVE INGREDIENT

Inactive ingredients Benzyl Alcohol, D&C Yellow 10, FD&C Blue 1, FD&C Red 40, Methylparaben, Natural and Artificial Flavor, Polyethylene Glycol, Propylene Glycol, Sodium Saccharin, Water

SPL UNCLASSIFIED SECTION

Distributed by: CVS Pharmacy, Inc.

One CVS Drive, Woonsocket, RI 02895

©2015 CVS/pharmacy

CVS.com 1-800-SHOP CVS

PRINCIPAL DISPLAY PANEL

CVS Health

MAXIMUM STRENGTH

Oral Anesthetic

BENZOCAINE 20%

0.5 FL OZ (14.7 mL)

INGREDIENTS AND APPEARANCE

CVS PHARMACY   MAXIMUM STRENGTH
benzocaine liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 59779-743
Route of Administration	DENTAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BENZOCAINE (UNII: U3RSY48JW5) (BENZOCAINE - UNII:U3RSY48JW5)	BENZOCAINE	20 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)
METHYLPARABEN (UNII: A2I8C7HI9T)
BENZYL ALCOHOL (UNII: LKG8494WBH)
FD&C RED NO. 40 (UNII: WZB9127XOA)
D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)

Product Characteristics
Color	orange (dark orange/red to sl brown)	Score
Shape		Size
Flavor	MINT (Mint)	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 59779-743-79	1 in 1 CARTON	01/01/2015
1		14.7 g in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part356	01/01/2015

Labeler - CVS Pharmacy (062312574)

Registrant - Lornamead Inc. (078584069)

Establishment
Name	Address	ID/FEI	Business Operations
CSR Cosmetic Solutions Inc.		243501959	manufacture(59779-743)