Label: CVS PHARMACY MAXIMUM STRENGTH- benzocaine gel, dentifrice
- NDC Code(s): 59779-582-09
- Packager: CVS Pharmacy
- Category: HUMAN OTC DRUG LABEL
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 Label Information
Updated January 26, 2023
If you are a healthcare professional or from the pharmaceutical industry please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Active ingredient
- Purpose
- Use
-
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
Stop use and ask a dentist or doctor if
- sore mouth symptoms do not get better in 7 days
- irritation, pain or redness persists or worsens
- swelling, rash or fever develops
-
Directions
- to open tube, cut tip of tube on score mark.
- adults and children 2 years of age and older: apply to affected area up to 4 times daily or as directed by dentist/doctor.
- 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 doctor / dentist.
- for denture irritation apply a thin layer to the affected area; do not reinsert dental work intil irritation/pain is relieved; rinse mouth well after reinserting
- Other Information
- Inactive ingredients
- PRINCIPAL DISPLAY PANEL
-
INGREDIENTS AND APPEARANCE
CVS PHARMACY MAXIMUM STRENGTH
benzocaine gel, dentifriceProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:59779-582 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength BENZOCAINE (UNII: U3RSY48JW5) (BENZOCAINE - UNII:U3RSY48JW5) BENZOCAINE 20 g in 100 g Inactive Ingredients Ingredient Name Strength POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) SACCHARIN SODIUM (UNII: SB8ZUX40TY) SORBIC ACID (UNII: X045WJ989B) GLYCERIN (UNII: PDC6A3C0OX) FD&C RED NO. 40 (UNII: WZB9127XOA) D&C YELLOW NO. 10 (UNII: 35SW5USQ3G) FD&C BLUE NO. 1 (UNII: H3R47K3TBD) WATER (UNII: 059QF0KO0R) Product Characteristics Color Score Shape Size Flavor MINT (Characteristic Mint) Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:59779-582-09 1 in 1 CARTON 01/20/2011 1 9 g in 1 TUBE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part356 01/20/2011 Labeler - CVS Pharmacy (062312574) Registrant - Lornamead (080046418) Establishment Name Address ID/FEI Business Operations Lornamead Inc. 080046418 manufacture(59779-582)