Cvs Maximum Toothache Relief Double Medicated (Benzocaine, Menthol) Gel [Cvs Pharmacy] -

CVS MAXIMUM TOOTHACHE RELIEF DOUBLE MEDICATED (BENZOCAINE, MENTHOL) GEL [CVS PHARMACY]
PDF | XML

NDC	69842-354-79, 69842-354-89, 69842-354-99
Set ID	81909b3a-36fa-3861-e053-2991aa0a5d16
Category	HUMAN OTC DRUG LABEL
Packager	CVS Pharmacy
Generic Name
Product Class
Product Number
Application Number	PART356

View All Sections

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

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
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

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

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
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 Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part356	02/10/2019	01/20/2022

Labeler - CVS Pharmacy (062312574)

Registrant - Lornamead Inc. (080046418)

Name	Address	ID/FEI	Business Operations
Establishment
Lornamead Inc.		080046418	manufacture(69842-354)

View All Sections