TOOTHACHE AND GUM RELIEF- benzocaine, menthol liquid

Toothache and Gum Relief by

Drug Labeling and Warnings

Toothache and Gum Relief by is a Otc medication manufactured, distributed, or labeled by CVS Pharmacy, Lornamead. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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Drug Facts

ACTIVE INGREDIENT

Active ingredients

Benzocaine 20%

Menthol 0.1%

PURPOSE

Purpose

Oral pain reliever

Oral pain reliever

INDICATIONS & USAGE

Uses

for the temporary relief of pain due to

• canker sores
• minor injury of the mouth and gums
• minor irritation of the mouth and gums caused by dentures

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

Stop use and ask a doctor if

• swelling, rash or fever develops
• irritation, pain or redness persists or worsens
• symptoms do not improve in 7 days
• allergic reaction occurs

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

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

Other information This preparation is intended for use in cases of toothache, only as a temporary expedient until a dentist can be consulted. Do not use continuously.

INACTIVE INGREDIENT

Inactive ingredients alcohol, flavor, polyethylene glycol, red 40, sodium saccharin, water, yellow 5

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TAMPER-EVIDENT: Carton is sealed for your protection.

Retain carton for complete product information.

Distributed by: CVS Pharmacy, Inc.

One CVS Drive, Woonsocket, RI 02895

CVS.com 1-800-SHOP-CVS

Made in Canada

PRINCIPAL DISPLAY PANEL

CVS Health™

SEVERE PAIN RELIEF

Toothache & Gum Relief Liquid

ORAL PAIN RELIEVER

DOUBLE MEDICATED​

• 20% BENZOCAINE to relieve oral pain
• MENTHOL to soothe

0.5 FL OZ (14.7 mL)

INGREDIENTS AND APPEARANCE

TOOTHACHE AND GUM RELIEF 
benzocaine, menthol liquid

Product 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
ALCOHOL (UNII: 3K9958V90M)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)
WATER (UNII: 059QF0KO0R)
FD&C RED NO. 40 (UNII: WZB9127XOA)

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)