CVS TOOTH AND GUM PAIN RELIEF CUSHIONS- benzocaine strip

CVS Tooth and Gum Pain Relief by

Drug Labeling and Warnings

CVS Tooth and Gum Pain 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 ingredient

Benzocaine 10%

PURPOSE

Purpose

Oral Pain Reliever

INDICATIONS & USAGE

Use

for the temporary relief of pain due to toothaches

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

• Carefully remove gel cushion from blister. Gently mold iwth fingers until soft. Apply to affected tooth/gum area and gently press for 5-10 seconds to mold for a comfortable fit. Gel cushion will stay in place and dissolve slowly in mouth.
• Adults and children 12 years of age and older: use up to 3 times daily or as directed by dentist or doctor.
• Children under 12 years of age: ask a dentist or doctor
• Children under 2 years of age: do not use

STORAGE AND HANDLING

Other information

Do not use if blister card is broken. 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. These toothache cushions are designed to completely dissolve in place.

Store at room temperature 15-30°C (59-86°F)

INACTIVE INGREDIENT

Inactive ingredients

Cellulose Gum, Flavor, Menthol, Polyethylene Glycol

SPL UNCLASSIFIED SECTION

Distributed by: CVS Pharmacy, Inc.

One CVS Drive

Woonsocket, RI 02895

©2017 CVS Pharmacy

CVS.com 1-800-SHOP CVS

Made in U.S.A.

PRINCIPAL DISPLAY PANEL

CVS Health™

Moldable Gel Cushions

Medicated

Tooth & Gum Pain Relief Cushions

BENZOCAINE 10%, ORAL PAIN RELIEVER

For Immediate Pain Relief

• Soothes & comforts
• Long lasting - stays in place twice as long as the leading gel*
• Great for use with braces

8 GEL CUSHIONS, 0.5 g EACH

*Based on lab dissolution study.

INGREDIENTS AND APPEARANCE

CVS TOOTH AND GUM PAIN RELIEF  CUSHIONS
benzocaine strip

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69842-381
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BENZOCAINE (UNII: U3RSY48JW5) (BENZOCAINE - UNII:U3RSY48JW5)	BENZOCAINE	10 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM (UNII: K679OBS311)
MENTHOL (UNII: L7T10EIP3A)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69842-381-09	8 in 1 CARTON	02/08/2019
1		0.5 g in 1 BLISTER PACK; 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	02/08/2019

Labeler - CVS Pharmacy (062312574)

Registrant - Lornamead Inc. (078584069)

Establishment
Name	Address	ID/FEI	Business Operations
Lornamead Inc.		078584069	manufacture(69842-381)