CVS Oral Anesthetic

Dosage form: liquid
Ingredients: BENZOCAINE 200mg in 1mL
Labeler: CVS Pharmacy
NDC Code: 59779-186

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, 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




CVS ORAL ANESTHETIC 
benzocaine liquid
Product Information
Product TypeHUMAN OTC DRUGItem 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 Description
1NDC:59779-186-511 TUBE, WITH APPLICATOR (TUBE) 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/FEIOperations
Pharma Pac, LLC140807475manufacture

Revised: 07/2010
 
CVS Pharmacy

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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