BENZALKONIUM: 279 Adverse Event Reports & Safety Profile

Full Prescribing Information: Description: Diabecin HR™ Cream contains 41.2 mg of Lidocaine HCl per gram, and 1.3 mg of Benzalkonium Chloride per gram in a vehicle of Aloe Barbadensis (Aloe Vera)

Leaf Juice

Powder, Aqua (Purified Water), Arnica Montana Flower Extract, Butyrospermum Parkii (Shea) Butter, Calendula Officinalis Flower Extract, Carbomer, Cetyl Alcohol, Chamomilla Recutita (Matricaria)

Flower

Extract, Cyclopentasiloxane, Dimethicone, Disodium EDTA, DL-alpha Tocopheryl Acetate, GenRx® Complex (Proprietary Blend), Glycerin, Glyceryl Acrylate/Acrylic Acid Copolymer, Glyceryl Stearate, Helianthus Annuus (Sunflower)

Seed

Oil, Methylsilanol Mannuronate, Panthenol, PEG-100 Stearate, Peucedanum Ostruthium (Masterwort)

Leaf

Extract, Phenoxyethanol, Propylene Glycol, Retinyl Palmitate, Sodium Lauroyl Sarcosinate, Stearic Acid, Tetrahexyldecyl Ascorbate, Triethanolamine, Vitis Vinifera (Grape)

Seed

Extract, Xanthan Gum, Zea Mays (Corn) Starch.

Warnings Methemoglobinemia warning: use of this product ay cause methemoglobinemia, a serious condition that must be treated promptly because it reduces the amount of oxygen carried in teh 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 lightneadedness * 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 Do not use * more than directed * for more than 7 days unless told to do so by a dentist or doctor * for teething * in children under 2 years of age Stop use and ask a doctor if * swelling, rash or fever develops * irritation, pain or redness persists or worsens * symptoms do not improve in 7 days * allergic reaction occurs Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

DIRECTIONS: DO NOT MICROWAVE Product and packaging are not sterile. Follow your hospital policy for skin preparation with non-sterile products. Using sterile scissors, cut off end seal of satchel. Transfer contents onto prep table.To reduce the risk of cloth contamination, avoid contact between cloths and the outside of package. Use first cloth to prepare the skin area indicated for a moist or dry site, making certain to keep the second cloth where it will not be contaminated. Use the second cloth to prepare larger areas. For dry surgical sites such as abdomen or arm, use one cloth to cleanse each 5 in. x 5 in. area (approx. 161 sq. cm) of skin to be prepared. Vigorously scrub skin back and forth for 3 minutes, completely wetting the treatment area. Discard cloth. Allow area to air dry for one (1) minute. Do not rinse. For moist surgical sites such as inguinal fold, use one cloth to cleanse 2 in. x 5 in. (approx. 65 sq. cm) of skin to be prepared. Vigorously scrub skin back and forth for 3 minutes, completely wetting the treatment area. Discard cloth. Allow area to air dry for one (1) minute. Do not rinse. Discard each cloth after single use. After satchel has been opened, discard any unused cloths.

CONTRAINDICATIONS: Tuberculosis or fungal lesions of the skin vaccinia, varicella and acute herpes simplex and in persons who have shown hypersensitivity to any of its components. Lidocaine is contraindicated in patients with a known history of hypersensitivity to local anesthetics of the amide type.

ADVERSE REACTIONS: Application Site Reactions Even though adverse reactions are rare, a very small percentage of patients experience an unpleasant burning sensation, redness, warmth, or stinging. It is advisable to apply a small amount on the forearm prior to first use. If any of these effects persist or worsen, contact your physician or pharmacist immediately. Systemic absorption of this medication is expected to be minimal when used as directed. However, if serious side effects occur (e.g., rash, swelling, severe dizziness), discontinue use and consult your pharmacist or physician. This is not a complete list of all possible side effects. You may report side effects to the FDA at 800-FDA-1088 or at http://www.fda.gov/medwatch.

Allergic

Reactions: Allergic and anaphylactoid reactions associated with lidocaine, although rare, can occur. They are characterized by angioedema, bronchospasm, dermatitis, dyspnea, hypersensitivity, laryngospasm, pruritus, shock, and urticaria. If they occur, they should be managed by conventional means. The detection of sensitivity by skin testing is of doubtful value.

Other Adverse

Events: Due to the nature and limitation of spontaneous reports in post marketing surveillance, causality has not been established for additional reported adverse events including: Asthenia, confusion, disorientation, dizziness, headache, hyperesthesia, hypoesthesia, lightheadedness, metallic taste, nausea, nervousness, pain exacerbated, paresthesia, somnolence, taste alteration, vomiting, visual disturbances such as blurred vision, flushing, tinnitus, and tremor. Systemic (Dose-Related) Reactions: Systemic adverse reactions following appropriate use of lidocaine is unlikely, due to the small dose absorbed (see CLINICAL PHARMACOLOGY, Pharmacokinetics). Systemic adverse effects of lidocaine are similar in nature to those observed with other amide local anesthetic agents, including CNS excitation and/or depression (light-headedness, nervousness, apprehension, euphoria, confusion, dizziness, drowsiness, tinnitus, blurred or double vision, vomiting, sensations of heat, cold or numbness, twitching, tremors, convulsions, unconsciousness, respiratory depression and arrest). Excitatory CNS reactions may be brief or not occur at all, in which case the first manifestation may be drowsiness merging into unconsciousness. Cardiovascular manifestations may include bradycardia, hypotension and cardiovascular collapse leading to arrest. To report SUSPECTED ADVERSE REACTIONS, contact Actavis at 1-800- 272-5525 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch for voluntary reporting of adverse reactions.

Warnings For external use only. Flammable, keep away from fire or flame. 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 Do not use
• in the eyes
• over large areas of the body
• if you are allergic to any ingredient in this product
• more than 3 times per day
• longer than 1 week unless directed by a physician
• for teething
• in children under 2 years of age Stop use and ask a dentist or physician if
• condition persists or worsens
• symptoms persist for more than 7 days Ask a physician if
• used to treat deep or puncture wounds, animal bites or serious burns
• you are pregnant or nursing a baby When using this product you may feel a brief stinging when you apply it. The sting should go away in a short time. Keep out of reach of children. In case of overdose, or allergic reaction, get medical help or contact a Poison Control Center right away

PRECAUTIONS: Allergic Reactions: Patients allergic to para-aminobenzoic acid derivatives (procaine, tetracaine, benzocaine, etc.) have not shown cross sensitivity to lidocaine. However, Diabecin HR™ Cream should be used with caution in patients with a history of drug sensitivities, especially if the etiologic agent is uncertain. Non-intact Skin: Application to broken or inflamed skin, although not tested, may result in higher blood concentrations of lidocaine from increased absorption. Diabecin HR™ Cream is only recommended for use on intact skin.

External Heat

Sources: Placement of external heat sources, such as heating pads or electric blankets, over Diabecin HR™ Cream is not recommended as this has not been evaluated and may increase plasma lidocaine levels.

Eye

Exposure: The contact of Diabecin HR™ Cream with eyes, although not studied, should be avoided based on the f indings of severe eye irritation with the use of similar products in animals. If eye contact occurs, immediately wash out the eye with water or saline and protect the eye until sensation returns.

Drug Interactions Antiarrhythmic Drugs: Diabecin HR™ Cream should be used with caution in patients receiving Class I antiarrhythmic drugs (such as tocainide and mexiletine) since the toxic effects are additive and potentially synergistic.

Local

Anesthetics: When Diabecin HR™ Cream is used concomitantly with other products containing local anesthetic agents, the amount absorbed from all formulations must be considered.

Benzalkonium chloride 0.13% ..................................Oral antiseptic Benzocaine 20% .....................................................Oral pain reliever Menthol 0.5% ........................................................Oral pain reliever Zinc chloride 0.15% ................................................Oral astringent

Inactive Ingredients Variant Gold: Inactive ingredients: Aqua (Water, Eau) · Sodium Chloride · Lauramidopropylamine Oxide · Glycerin · Cetrimonium Chloride · Lauramine Oxide · PEG-120 Methyl Glucose Dioleate · Citric Acid · Sodium Benzoate · Myristamidopropylamine Oxide · Parfum (Fragrance) · Aloe Barbadensis Leaf Juice · Zinc Sulfate · Trisodium Ethylenediamine Disuccinate · Dimethyl Lauramine. Alcohol. CI 19140 (yellow 5). CI 14700 (Red 4)

Variant

Lav & Jasmine: Inactive ingredients: Aqua (Water, Eau) · Sodium Chloride · Lauramidopropylamine Oxide · Glycerin · Cetrimonium Chloride · Lauramine Oxide · PEG-120 Methyl Glucose Dioleate · Citric Acid · Sodium Benzoate · Parfum (Fragrance) · Myristamidopropylamine Oxide · Aloe Barbadensis Leaf Juice · Zinc Sulfate · Trisodium Ethylenediamine Disuccinate · Dimethyl Lauramine. Alcohol. CI 17200 (Red 33). CI 42090 (Blue 1)

Variant White

Tea: Inactive ingredients: Aqua (Water, Eau) · Sodium Chloride · Lauramidopropylamine Oxide · Glycerin · Cetrimonium Chloride · Lauramine Oxide · PEG-120 Methyl Glucose Dioleate · Citric Acid · Sodium Benzoate · Myristamidopropylamine Oxide · Parfum (Fragrance) · Aloe Barbadensis Leaf Juice · Zinc Sulfate · Trisodium Ethylenediamine Disuccinate · Dimethyl Lauramine · Alcohol · Camellia Sinensis Leaf Extract · CI 42090 (Blue 1) · CI 17200 (Red 33)

Variant

Pom & Tangerine: Inactive ingredients: Aqua (Water, Eau) · Sodium Chloride · Lauramidopropylamine Oxide · Glycerin · Cetrimonium Chloride · Lauramine Oxide · PEG-120 Methyl Glucose Dioleate · Citric Acid · Sodium Benzoate · Parfum (Fragrance) · Myristamidopropylamine Oxide · Aloe Barbadensis Leaf Juice · Zinc Sulfate · Trisodium Ethylenediamine Disuccinate · Dimethyl Lauramine · Alcohol · CI 15985 (Yellow 6) · CI 17200 (Red 33) · CI16035 (Red 40) Variant AB & Sensitive Aloe: Inactive ingredients: Aqua (Water, Eau) · Lauramidopropylamine Oxide · Sodium Chloride · Glycerin · Cetrimonium Chloride · Lauramine Oxide · PEG-120 Methyl Glucose Dioleate · Citric Acid · Sodium Benzoate · Myristamidopropylamine Oxide · Parfum (Fragrance) · Aloe Barbadensis Leaf Juice · Zinc Sulfate · Trisodium Ethylenediamine Disuccinate · Dimethyl Lauramine · Alcohol Variant AB Fragrance Free: Inactive ingredients: Aqua (Water, Eau) · Sodium Chloride · Lauramidopropylamine Oxide · Glycerin · Cetrimonium Chloride · Lauramine Oxide · PEG-120 Methyl Glucose Dioleate · Citric Acid · Sodium Benzoate · Myristamidopropylamine Oxide · Aloe Barbadensis Leaf Juice · Zinc Sulfate · Trisodium Ethylenediamine Disuccinate · Dimethyl Lauramine · Alcohol Variant Lemon & Sage: Inactive ingredients: Aqua (Water, Eau) · Sodium Chloride · Lauramidopropylamine Oxide · Glycerin · Cetrimonium Chloride · Lauramine Oxide · PEG-120 Methyl Glucose Dioleate · Citric Acid · Sodium Benzoate · Myristamidopropylamine Oxide · Parfum (Fragrance) · Aloe Barbadensis Leaf Juice · Zinc Sulfate · Trisodium Ethylenediamine Disuccinate · Dimethyl Lauramine · Alcohol · CI 19140 (Yellow 5) · CI 14700 (Red 4)

Variant Spring

Water: Inactive ingredients: Aqua (Water, Eau) · Sodium Chloride · Lauramidopropylamine Oxide · Glycerin · Cetrimonium Chloride · Lauramine Oxide · PEG-120 Methyl Glucose Dioleate · Citric Acid · Sodium Benzoate · Parfum (Fragrance) · Myristamidopropylamine Oxide · Aloe Barbadensis Leaf Juice · Zinc Sulfate · Trisodium Ethylenediamine Disuccinate · Dimethyl Lauramine · Alcohol · CI 42090 (Blue 1) · CI 17200 (Red 33)