CVS ORAL ANESTHETIC- benzocaine liquid

CVS Oral Anesthetic by

Drug Labeling and Warnings

CVS Oral Anesthetic 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, 20%........................................Oral Anesthetic

PURPOSE

Uses

- temporary relieves pain associated with the following mouth and gum irritations:     
- toothache  - canker sores   - sore gums    - braces    - dentures
- minor dental procedures

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children. If more than is used for pain is accidentally
swallowed, get medical help or contact a Poison Control Center right away.

INDICATIONS & USAGE

Uses

- temporary relieves pain associated with the following mouth and gum irritations:     
- toothache  - canker sores   - sore gums    - braces    - dentures
- minor dental procedures

WARNINGS

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.

When using this product

- avoid contact with 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 dentist or a doctor if

- sore mouth symptoms do not improve in 7 days
- swelling, rash or fever develops
- irritation, pain or redness persists or worsens

Keep out of reach of children.If more then used for pain is accidentally swallowed,
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 the affected area
- wipe liquid on with cotton, or cotton swab, or fingertip
- apply up to 4 times daily or as recommended by a doctor/dentist

- Children under 12 years of age: adult supervision should be given in the use of this product

- children under 2 years of age: consult a dentist or doctor

INACTIVE INGREDIENT

Inactive Ingredients

benzyl alcohol, D and C Yellow no 10, FD and C Blue no 1, FD and C Red no 40,
flavor, methylparaben, polyethylene glycol, propylene glycol, saccharin

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

CVS ORAL ANESTHETIC 
benzocaine liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 59779-186
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BENZOCAINE (UNII: U3RSY48JW5) (BENZOCAINE - UNII:U3RSY48JW5)	BENZOCAINE	200 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
BENZYL ALCOHOL (UNII: LKG8494WBH)
D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)
FD&C RED NO. 40 (UNII: WZB9127XOA)
SPEARMINT OIL (UNII: C3M81465G5)
PEPPERMINT OIL (UNII: AV092KU4JH)
METHYLPARABEN (UNII: A2I8C7HI9T)
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
SACCHARIN (UNII: FST467XS7D)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 59779-186-51	1 in 1 CARTON
1		30 mL in 1 TUBE, WITH APPLICATOR

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part356	07/08/2010

Labeler - CVS Pharmacy (062312574)

Registrant - Pharma Pac, LLC (140807475)

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