FDA Label for Cainetips

View Indications, Usage & Precautions

Cainetips Product Label

The following document was submitted to the FDA by the labeler of this product J Morita Usa Inc. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

Active Ingredient



BENZOCAINE 20%


Purpose



PAIN RELIEVER


Uses



For temporary relief of pain due to: minor dental procedures, minor mouth and/or gum irritation caused by dentures or orthodontic appliances, Vincent's infection, or canker sores.


Warnings



Do not use: if patient is allergic to local anesthetics such as procaine, butacaine, benzocaine, or other "caine" anesthetics;
exceeding recommended dosage for more than 7 days unless directed by a dentist; if sore mouth symptoms
do not improve in 7 days; if irritation, pain or redness persists or worsens; or if swelling, rash or fever develops, see a
dentist or a physician promptly.


Pregnancy



If pregnant or breast feeding, ask a health professional before use.


Otc - Keep Out Of Reach Of Children



Keep out of reach of children.


Directions



HOLD WITH SOLID WHITE TIP STRAIGHT DOWN; BEND AND SNAP OPEN UPPER TIP AT COLORED RING; ALLOW MEDICINE TO FLOW DOWN.

APPLY PRODUCT TO INTENDED AREA; ALLOW IT TO REMAIN IN PLACE AT LEAST 1 MINUTE AND THEN REMOVE IT FROM MOUTH; DISPOSE AFTER APPLICATION.

USE UP TO 4 TIMES DAILY, OR AS DIRECTED BY A DENTIST. ADULT SUPERVISION REQUIRED FOR USE WITH CHILDREN UNDER 12 YEARS. CONSULT A DENTAL PROFESSIONAL FOR USE WITH CHILDREN UNDER 2 YEARS.


Inactive Ingredients



ARTIFICIAL FLAVOR, POLYETHYLENE GLYCOL, ETHOXY DIGLYCOL


Package Label.Principal Display Panel




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