Active Ingredient(S)
Benzocaine 2.5%
Bvibe Spearmint Deep Throat Liquid
FDA Label NDC 85775-112
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Cotr Inc for the product Bvibe Spearmint Deep Throat (NDC 85775-112). 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
Oral Anesthetic
Use
Temporarily reduces gag reflex by desensitizing the throat for deeper oral activity.
Warnings
For external use only. Do not apply to genitals or other body parts.
Allergy Alert: Avoid if allergic to benzocaine or other local anesthetics (e.g., lidocaine, procaine)
Do Not Use: If you have a history of methemoglobinemia or take related medications (e.g., nitrates, sulfonamides).
On irritated or broken mucous membranes.
When Using: Avoid eyes/nostrils; rinse if contact occurs.
Do not swallow immediately; allow throat numbing.
Avoid eating/drinking for 1 hour post-use to prevent choking.
Seek immediate medical help for excessive numbness, breathing issues, dizziness, or bluish skin.
Stop Use and Consult a Doctor If: Severe burning, swelling, irritation, rash, or prolonged numbing (>1-2 hours) occurs.
Ask a Doctor Before Use If: You have respiratory, heart, or liver issues, are pregnant/breastfeeding, or take interacting medications.
Keep Out of Reach of Children: Contact Poison Control
(1-800-222-1222) if swallowed.
• Other Warnings: Overuse may increase methemoglobinemia risk.
Avoid continuous/large
Otc - Keep Out Of Reach Of Children
Keep out of reach of childeren.Contact Poison Control if
Directions
Adults (18+): 1-2 sprays to throat, max 3-4 per use.
Allow 30-60 seconds before swallowing; wait 1-2 minutes for full effect.
Numbing fades within 1 hour. Max 4 sprays/session, 12 sprays/24 hours.
Store at 68°-77°F, away from heat/sunlight.
Other Information
Inactive Ingredients
Purified Water, Ethyl Alcohol, Glycerin, Acesulfame Potassium, Sucralose, Flavor, Citric Acid, Sodium Benzoate, Potassium
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