Active Ingredient(S)
Benzocaine (7.5%)
A And E Deep Throat Desensitizing Spraypeppermint Spray
FDA Label NDC 87068-182
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Phe Inc for the product A And E Deep Throat Desensitizing Spraypeppermint (NDC 87068-182). 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 active ingredient(s), purpose, use, warnings, otc - keep out of reach of children, directions, other information, inactive ingredients, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
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
Label (Anal Pepermint)
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