BENZOCAINE: 548 Adverse Event Reports & Safety Profile

DIRECTIONS Isolate verruca with adhesive tape. Remove weight bearing pressure by using felt pad with aperture.

Apply

Salinocaine to verruca and dress with waterproof tape to guard against water dilution. Repeat treatment every 10 days if needed.

Each Gram

Contains: 550mg of Salicylic acid and 20mg of Benzocaine.

Also

Contains: Petrolatum, Glycerin, Benzalkonium Chloride 0.1% added as a preservative. Premier ® Medical Products 1710 Romano Drive Plymouth Meeting, PA 19462 USA (610) 239-6053 www.premusa.com Technology by Medical Products Laboratories, Inc. Philadelphia, PA 19115-1083, U.S.A. For external use only. Caution: Federal (U.S.A.) law prohibits dispensing without prescription. Made in U.S.A. To obtain a MSDS Sheet, visit www.premusa.com or call Premier Customer Service at (610) 239-6053.

Discontinue use and consult a doctor if This product, used as directed does not provide relief You or your partner develops a rash or irritation, such as burning or itching Condition worsens or if symptoms persist for more than 7 days or clear up and occur again within a few days The following symptoms appear: weakness, confusion, headache, difficulty breathing and/or pale, gray or blue colored skin as these may be signs of methemoglobinemia, a rare disorder which may appear up to 2 hours of use Warnings DO NOT use if allergic to Benzocaine or any other ingredient in this product If swallowed seek medical assistance or contact a poison control or contact a poison control Center right away. Premature ejaculation may be due to condition requiring medical supervision Consult a doctor prior to use if partner is pregnant Avoid contact with eyes: if this happens, rinse thoroughly with water Known adverse reactions Hypersensitivity/allergy has been known to occur, in such a case, discontinue use. Directions for use Adults, 18 and over. Apply a small amount to head and shaft of penis 5-10 minutes before intercourse, or use as directed by a health care practitioner. Use the smallest amount to achieve the desired result. Wipe off any excess gel before intercourse. Wash product off after intercourse. For external Use only.

Inactive

Inagredients: Blue 1 (CI 42090), Disodium EDTA, Hydroxyethylcellulose, Mentha Piperita (peppermint oil), PEG-8, Polysorbate 60, Propylene Glycol, Sodium Saccharin, Water (Aqua/Eau), Yellow 5 (CI 19140), Yellow 6 (CI 15985)

Dosage and Administration Cetacaine Spray should be applied for approximately one second or less for normal anesthesia. Only a limited quantity of Cetacaine is required for anesthesia. Spray in excess of two seconds is contraindicated. Each one-second spray contains an average of 200 mg of product, not including propellant. To apply, insert the cannula firmly onto the protruding plastic stem on the bottle and press the cannula forward to actuate the spray valve. The cannula may be removed and reinserted as many times as required for cleaning, or sterilization, and is autoclavable.

Cetacaine Liquid Apply

200 mg liquid (approximately 0.2 mL) directly to tissue. Liquid in excess of 400 mg (approximately 0.4 mL) is contraindicated. To apply, remove and discard the shipping cap from the bottle. Replace it with the supplied Luer-lock cap. Caution: Do not over-tighten. Remove small cap from luer-lock port, retaining it for replacement after use. Port allows for a single dip of a cotton or brush applicator for application directly to accessible mucous membrane. For application into periodontal pockets, Cetylite Luer-lock syringes and Microcapillary Delivery Tips are recommended.

Cetylite

Syringes are clearly marked in (4) 0.1 mL increments. To fill, attach syringe to port by gently twisting clockwise until secure. Invert and draw desired amount of liquid into the syringe. Remove filled syringe and attach Microcapillary Delivery Tip to the syringe. Tip may be bent to improve access. Apply drop-wise to accessible mucous membrane (such as buccal and lingual sulcus) by slowly depressing the syringe plunger. Discard all applicators after use. An appropriate pediatric dosage has not been established for Cetacaine Spray or Cetacaine Liquid. Dosages should be reduced in the debilitated elderly, acutely ill, and very young patients (i.e., children 2 years and older). Do not use Cetacaine Spray or Cetacaine Liquid to treat infants or children younger than 2 years. Tissue need not be dried prior to application of Cetacaine. Cetacaine should be applied directly to the site where pain control is required. Anesthesia is produced within one minute with an approximate duration of thirty minutes.

Each

200 mg dose of Cetacaine (Spray or Liquid) contains 28 mg of benzocaine, 4 mg of butamben and 4 mg of tetracaine HCl.

Contraindications Do not use Cetacaine Gel to treat infants or children younger than 2 years. Cetacaine is not suitable and should never be used for injection. Do not use on the eyes. To avoid excessive systemic absorption, Cetacaine Topical Anesthetic Gel should not be applied to large areas of denuded or inflamed tissue.

Cetacaine Topical Anesthetic

Gel should not be administered to patients who are hypersensitive to any of its ingredients or to patients known to have cholinesterase deficiencies. Tolerance may vary with status of the patient.

Cetacaine Topical Anesthetic

Gel should not be used under dentures or cotton rolls, as retention of the active gel ingredients under a denture or cotton roll could possibly cause an escharotic effect. Routine precaution for the use of any topical anesthetic should be observed when using Cetacaine Topical Anesthetic Gel.

Adverse Reactions: Methemoglobinemia has been reported following the use of benzocaine on extremely rare occasions. Intravenous methylene blue is the specific therapy for this condition.

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 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. If a skin reaction occurs, stop use and seek medical help right away.

Sore Throat

Warning : Severe or persistent sore throat or sore throat accompanied by high fever, headache, nausea, and vomiting may be serious. Consult doctor promptly. Do not use more than 2 days or administer to children under 6 years of age unless directed by a doctor. Do not use this product if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric or emotional conditions, or Parkinson’s disease), or for 2 weeks after stopping the MAOI drug. If you are uncertain whether your prescription drug contains an MAOI, consult a health care professional before taking this product for teething in children under 6 years of age Ask a doctor before use if you have a persistent or chronic cough such as occurs with smoking, asthma, or emphysema a cough is accompanied by excessive phlegm (mucus) When using this product do not exceed recommended dosage. Stop use and ask a dentist or doctor if sore mouth symptoms do not improve in 7 days irritation, pain or redness persists or worsens swelling, rash or fever develops cough persists for more than 1 week, tends to recur, or is accompanied by a high fever, rash, or persistent headache. These could be symptoms of a serious condition. If pregnant or breast-feeding, ask a health care professional before use. Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

DRUG INTERACTIONS Patients that are administered local anesthetics may be at increased risk of developing methemoglobinemia when concurrently exposed to the following oxidizing agents: Class Examples Nitrates/Nitrites nitroglycerin, nitroprusside, nitric oxide, nitrous oxide Local anesthetics benzocaine, lidocaine, bupivacaine, mepivacaine, tetracaine, prilocaine, procaine, articaine, ropivacaine Antineoplastic agents cyclophosphamide, flutamide, rasburicase, ifosfamide, hydroxyurea Antibiotics dapsone, sulfonamides, nitrofurantoin, para-aminosalicylic acid Antimalarials chloroquine, primaquine Anticonvulsants phenytoin, sodium valproate, phenobarbital Other drugs acetaminophen, metoclopramide, sulfa drugs (i.e., sulfasalazine), quinine

Active Ingredients Purpose Benzocaine 5.0 % Male genital desensitizer Use Helps in temporarily prolonging time until ejaculation Keep out of reach of children. Discontinue use and consult a doctor if This product, used as directed does not provide relief You or your partner develops a rash or irritation, such as burning or itching Condition worsens or if symptoms persist for more than 7 days or clear up and occur again within a few days The following symptoms appear: weakness, confusion, headache, difficulty breathing and/or pale, gray or blue colored skin as these may be signs of methemoglobinemia, a rare disorder which may appear up to 2 hours of use Warnings DO NOT use if allergic to Benzocaine or any other ingredient in this product If swallowed seek medical assistance or contact a poison control or contact a poison control Center right away. Premature ejaculation may be due to condition requiring medical supervision Consult a doctor prior to use if partner is pregnant Avoid contact with eyes: if this happens, rinse thoroughly with water Known adverse reactions Hypersensitivity/allergy has been known to occur, in such a case, discontinue use. Directions for use Adults, 18 and over. Apply a small amount to head and shaft of penis 5-10 minutes before intercourse, or use as directed by a health care practitioner. Use the smallest amount to achieve the desired result. Wipe off any excess gel before intercourse. Wash product off after intercourse. For external Use only.

Inactive

Inagredients: Blue 1 (CI 42090), Disodium EDTA, Hydroxyethylcellulose, Mentha Piperita (peppermint oil), PEG-8, Polysorbate 60, Propylene Glycol, Sodium Saccharin, Water (Aqua/Eau), Yellow 5 (CI 19140), Yellow 6 (CI 15985)

Water, mineral oil, cetyl alcohol, propylene glycol, glyceryl stearate, PEG-100 stearate, isopropyl palmitate, ocimum basilicum (basil) leaf extract, chamomilla recutita (matricaria) flower extract, calendula officinalis flower extract, chrysanthemum parthenium (feverfew) extract, melia azadirachta leaf extract, glycerin, tocopheryl acetate, aloe barbadensis leaf extract, retinyl palmitate, cholecalciferol, mentha piperita (peppermint) oil, zea mays (corn) oil, isopropyl myristate, carbomer, triethanolamine, lanolin, disodium EDTA, sodium sulfite, methylparaben.