Label: CVS ORAL ANESTHETIC- benzocaine liquid
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
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.
Updated July 8, 2010
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- ACTIVE INGREDIENT
- KEEP OUT OF REACH OF CHILDREN
- INDICATIONS & USAGE
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
- 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
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