FDA Label for A And E Deep Throat Desensitizing Spraypeppermint
View Indications, Usage & Precautions
A And E Deep Throat Desensitizing Spraypeppermint Product Label
The following document was submitted to the FDA by the labeler of this product Phe 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(S)
Benzocaine (7.5%)
Purpose
Desensitizer
Use
For occasional personal use to help prevent the gag reflex.
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
Otc - Keep Out Of Reach Of Children
Keep out of reach of childeren. Contact a Poison Control Center: This is the emergency contact for accidental overdose or ingestion
Directions
Adults 18 years of age and older: Apply 2-3 sprays to the back of the throat. Limit use to 3-4 times per day.
For adults only. Not for sale to minors.
Other Information
Store at 20-25°C (68-77°F)
Inactive Ingredients
Purified Water, Glycerin, Alcohol, Acesulfame Potassium, Sucralose, Potassium Sorbate, Sodium Benzoate, Citric Acid, Natural Flavor (Peppermint)
Package Label - Principal Display Panel
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