- ACTIVE INGREDIENT
- PURPOSE
- KEEP OUT OF REACH OF CHILDREN
- INDICATIONS & USAGE
-
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
- PRINCIPAL DISPLAY PANEL
-
INGREDIENTS AND APPEARANCE
CVS ORAL ANESTHETIC
benzocaine liquidProduct 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