FDA Label for Zapotol Dentidol Oral Analgesic
View Indications, Usage & Precautions
Zapotol Dentidol Oral Analgesic Product Label
The following document was submitted to the FDA by the labeler of this product Productos Zapotol Corp.. 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.
Otc - Active Ingredient
Active ingredients Purpose
Benzocaine 20%.................................................................. Oral pain reliever
Benzalkonium chloride 0.1%................................................. Antiseptic
Otc - Purpose
Uses
- temporarily relieves pain due to toothache, canker sores, cold sores, fever blisters, minor irritation of the mouth and gums caused by dentures or orthodontic appliances.
- to help protect against infection in minor oral irritation.
Warnings
Warnings
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 directed by a doctor/dentist
Otc - Stop Use
Stop use and ask a dentist or doctor if
- swelling, rash, or fever develops
- irritation, pain, or redness persists or worsens
- symptoms do not improve in 7 days
Otc - Keep Out Of Reach Of Children
Keep out of reach of children. In case of overdose or allergic reaction, get medical help or contact a Poison Control Center right away.
Indications & Usage
Directions
- remove cap and cut tip of tube on score mark
- adults and children 2 years of age and older: apply a small amount of Oral Analgesic Gel to the cavity and around gum surrounding the teeth. Use up to 4 times daily or as directed by doctor or dentist.
- children under 12 years of age should be supervised in the use of this product
- children under 2 years of age: ask a doctor/dentist
Storage And Handling
Other information
- store at 15°-25°C (59°-77°F)
- do not use if tube tip is cut prior to opening
- this preparation is intended for use in cases of toothaches, only as temporary expedient until a dentist can be consulted.
- do not use continuously
- Lot No. & Exp Date: see crimp of tube.
Inactive Ingredient
Inactive ingredients
glycerin, peppermint oil, polyethylene glycol 400, polyethylene glycol 4000, saccharin sodium, sorbitol
Dosage & Administration
Distributed by:
Productos Zapotol Corp.
Palmdale, CA 93550
Made in Korea
Package Label.Principal Display Panel
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