Label: TOOTHACHE AND GUM RELIEF- benzocaine, menthol liquid
- NDC Code(s): 69842-353-29
- 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
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- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- ACTIVE INGREDIENT
- PURPOSE
- INDICATIONS & USAGE
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WARNINGS
Warnings
Methemoglobinemia warning: use of this product may cause methemoglobinemia, a serious condition that must be treated promptly because it reduces the amount of oxygen carried in blood. This can occur even if you have used this product before. Stop use and seek immediate medical attention if you or a child in your care develops:
- pale, gray or blue colored skin (cyanosis)
- headache
- rapid heart rate
- shortness of breath
- dizziness or lightheadedness
- fatigue or lack of energy
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
Do not use
- more than directed
- for more than 7 days unless told to do so by a dentist or doctor
- for teething
- in children under 2 years of age
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DOSAGE & ADMINISTRATION
Directions
- do not use if package has been opened
- adults and children 2 years of age and older: using applicator tip, apply to the cavity and around the gum surrounding the teeth. Use up to 4 times daily or as directed by a dentist or doctor. Children 12 years of age should be supervised in the use of this product
- children under 2 years of age: do not use
- OTHER SAFETY INFORMATION
- INACTIVE INGREDIENT
- SPL UNCLASSIFIED SECTION
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
TOOTHACHE AND GUM RELIEF
benzocaine, menthol liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:69842-353 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength BENZOCAINE (UNII: U3RSY48JW5) (BENZOCAINE - UNII:U3RSY48JW5) BENZOCAINE 20 g in 100 mL MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL 0.1 g in 100 mL Inactive Ingredients Ingredient Name Strength POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A) FD&C YELLOW NO. 5 (UNII: I753WB2F1M) WATER (UNII: 059QF0KO0R) FD&C RED NO. 40 (UNII: WZB9127XOA) ALCOHOL (UNII: 3K9958V90M) SACCHARIN SODIUM (UNII: SB8ZUX40TY) Product Characteristics Color orange (Red orange) Score Shape Size Flavor FRUIT Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:69842-353-29 1 in 1 CARTON 02/07/2019 1 14.7 mL in 1 BOTTLE, WITH APPLICATOR; 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 02/07/2019 Labeler - CVS Pharmacy (062312574) Registrant - Lornamead (080046418) Establishment Name Address ID/FEI Business Operations Lornamead 080046418 manufacture(69842-353)