Other
Drug Facts
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
Toothache And Gum Relief Liquid
FDA Label NDC 69842-353
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Cvs Pharmacy for the product Toothache And Gum Relief (NDC 69842-353). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding other, otc - active ingredient, otc - purpose, indications & usage, warnings, otc - do not use, otc - stop use, otc - keep out of reach of children, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Active Ingredient
Active ingredients
Benzocaine 20%
Menthol 0.1%
Otc - 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
Otc - Do Not Use
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
Otc - Stop Use
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
Otc - Keep Out Of Reach Of Children
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
Package Label.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)
Cvs_severepain_liquid_ctn_f8015375 (Cvs Severepain Liquid Ctn F8015375)
* Please review the disclaimer below.
