Your browser does not support JavaScript! CVS ORAL ANESTHETIC (BENZOCAINE) LIQUID [CVS PHARMACY]
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CVS ORAL ANESTHETIC (benzocaine) liquid
[CVS Pharmacy]


Category DEA Schedule Marketing Status
HUMAN OTC DRUG LABEL OTC monograph final
NOTE: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 Label Sections

Active ingredient                                 Purpose

Benzocaine, 20%........................................Oral Anesthetic



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


Uses

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

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.


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 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


c


CVS ORAL ANESTHETIC 
benzocaine liquid
Product Information
Product TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:59779-186
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BENZOCAINE (BENZOCAINE) BENZOCAINE200 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
BENZYL ALCOHOL 
D&C YELLOW NO. 10 
FD&C RED NO. 40 
SPEARMINT OIL 
PEPPERMINT OIL 
METHYLPARABEN 
POLYETHYLENE GLYCOL 400 
PROPYLENE GLYCOL 
SACCHARIN 
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:59779-186-511 in 1 CARTON
130 mL in 1 TUBE, WITH APPLICATOR
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35607/08/2010
Labeler - CVS Pharmacy (062312574)
Registrant - Pharma Pac, LLC (140807475)
Establishment
NameAddressID/FEIBusiness Operations
Pharma Pac, LLC140807475manufacture

Revised: 7/2010
 
CVS Pharmacy

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