CVS MAXIMUM TOOTHACHE RELIEF DOUBLE MEDICATED- benzocaine, menthol gel

CVS Maximum Toothache Relief by

Drug Labeling and Warnings

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

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

ACTIVE INGREDIENT

Active ingredients

Benzocaine 20%

Menthol 0.26%

PURPOSE

Purpose

Oral pain reliever

Oral Pain reliever

INDICATIONS & USAGE

Use

• for the temporary relief of pain due to minor irritation or injury of the mouth and gums

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 directed 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

• cut open tip of tube on score mark
• adults and children 2 years of age and older: apply a small amount of the product 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 under 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

• do not use if tip is cut prior to opening
• 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
• this formula will stay in place for extended duration of relief
• avoid using toothpaste or drinking soft drinks or fruit juices for at least one hour after applying

INACTIVE INGREDIENT

Inactive ingredientsammonium glycyrrhizate, flavor, polyethylene glycol, sodium saccharin, sorbic acid

SPL UNCLASSIFIED SECTION

TAMPER EVIDENT: Do not use if tube tip is cut prior to use.

Distributed by: CVS Pharmacy, Inc.

One CVS Drive, Woonsocket, RI 02895

©2019 CVS/pharmacy

CVS.com 1-800-SHOP CVS

PRINCIPAL DISPLAY PANEL

CVS Health™

MAXIMUM PAIN RELIEF

Toothache Relief Gel

ORAL PAIN RELIEVER

DOUBLE MEDICATED

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

NET WT 0.25 OZ (7g)

INGREDIENTS AND APPEARANCE

CVS MAXIMUM TOOTHACHE RELIEF  DOUBLE MEDICATED
benzocaine, menthol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69842-354
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	0.26 g  in 100 g
BENZOCAINE (UNII: U3RSY48JW5) (BENZOCAINE - UNII:U3RSY48JW5)	BENZOCAINE	20 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
SACCHARIN SODIUM (UNII: SB8ZUX40TY)
SORBIC ACID (UNII: X045WJ989B)
AMMONIUM GLYCYRRHIZATE (UNII: 3VRD35U26C)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69842-354-79	1 in 1 CARTON	02/10/2019
1		7 g in 1 TUBE; Type 0: Not a Combination Product
2	NDC: 69842-354-89	1 in 1 CARTON	02/10/2019	02/10/2019
2		9.4 g in 1 TUBE; Type 0: Not a Combination Product
3	NDC: 69842-354-99	1 in 1 CARTON	02/10/2019	02/10/2019
3		12 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	02/10/2019

Labeler - CVS Pharmacy (062312574)

Registrant - Lornamead Inc. (078584069)

Establishment
Name	Address	ID/FEI	Business Operations
Lornamead Inc.		078584069	manufacture(69842-354)