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| Product NDC Code | 53045-130 | ||||
|---|---|---|---|---|---|
| Drug Name | Iolite |
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| Type | Brand | ||||
| Pharm Class | Allergens [CS], Cell-mediated Immunity [PE], Increased Histamine Release [PE], Standardized Chemical Allergen [EPC] |
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| Active Ingredients |
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| Route | DENTAL, ORAL | ||||
| Dosage Form | GEL | ||||
| Application Number | M022 | ||||
| Labeler Name | Dharma Research, Inc. | ||||
| Packages |
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| Check if available Online | Get Medication Prices online with Discount |
Active ingredient
A list of the active, medicinal ingredients in the drug product.Active Ingredient Benzocaine, 20%
Dosage and administration
Information about the drug product’s dosage and administration recommendations, including starting dose, dose range, titration regimens, and any other clinically sigificant information that affects dosing recommendations.Directions Adults and children 2 years of age and older: Apply to the affected area. 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: Consult a dentist or doctor.
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive Ingredients FD&C Red #40, Flavor, Polyethylene glycol 3350, Polyethylene glycol 400, Saccharine sodium, Tocopheryl acetate, Xylitol
Indications and usage
A statement of each of the drug products indications for use, such as for the treatment, prevention, mitigation, cure, or diagnosis of a disease or condition, or of a manifestation of a recognized disease or condition, or for the relief of symptoms associated with a recognized disease or condition. This field may also describe any relevant limitations of use.Uses For the temporary relief of pain associated with canker sores and minor dental procedures.
Purpose
Information about the drug product’s indications for use.Purpose Oral anesthetic
Spl product data elements
Usually a list of ingredients in a drug product.Iolite Benzocaine BENZOCAINE BENZOCAINE FD&C RED NO. 40 POLYETHYLENE GLYCOL 3350 POLYETHYLENE GLYCOL 400 SACCHARIN SODIUM .ALPHA.-TOCOPHEROL ACETATE XYLITOL
Package label principal display panel
The content of the principal display panel of the product package, usually including the product’s name, dosage forms, and other key information about the drug product.Iolite Oral Anesthetic Gel Bubble Gum with Vitamin E and Xylitol Gluten Free 1.12 oz (32 g) Manufactured by Dharma Research, Inc., 5220 NW 72nd Ave, Unit 15, Miami, FL 33166 1-877-833-3725 www.dharmaresearch.com 20201013_130_RevD
Spl unclassified section
Information not classified as belonging to one of the other fields. Approximately 40% of labeling with effective_time between June 2009 and August 2014 have information in this field.Other Information Store at room temperature 59-86°F (15-30°C). Protect from freezing and heat.
Keep out of reach of children
Information pertaining to whether the product should be kept out of the reach of children, and instructions about what to do in the case of accidental contact or ingestion, if appropriate.Keep Out of Reach of Children. If more than used for pain is accidentially swallowed, get medical help or contact a Poison Control center right away.
Warnings
Information about serious adverse reactions and potential safety hazards, including limitations in use imposed by those hazards and steps that should be taken if they occur.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 the blood. This can occur even if you have used this product before. Stop use and seek 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 Alergy 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 this product for more than 7 days unless directed by a dentist or doctor. 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 your dentist or doctor promptly. Do not exceed recommended dosage.
Disclaimer: Do not rely on openFDA or Phanrmacy Near Me to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Source: OpenFDA, Healthporta Drugs API