Otc - Active Ingredient
Benzocaine
Menthol
Cvs 2x Liq (csr)
FDA Label NDC 49354-353
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Csr Cosmetic Solutions for the product Cvs 2x Liq (csr) (NDC 49354-353). 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 otc - active ingredient, otc - purpose, indications & usage, warnings, otc - keep out of reach of children, dosage & administration, other safety information, inactive ingredient, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Purpose
Oral pain reliever
Oral pain reliever
Indications & Usage
fo rthe 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
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
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
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 tooth. 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
this preparation is intended for use in cases of toothache, only as a temporary expedient until a dentist can be consulted. Do not use continually.
Inactive Ingredient
alcohol, flavor, polyethylene glycol, red 40, sodium saccharin, water, yellow 5
* Please review the disclaimer below.
