LDO Plus™ is a medicated Hydrogel wound dressing in a Metered Dose (MDOSE™) bottle containing lidocaine 4%, an amide type local anesthetic, indicated for: Painful wounds such as post-surgical incisions, cuts and abrasions.

DOSAGE
Apply to the affected area as directed. Maximum 12 pumps per day.

LDO Plus is a topical medicated hydrogel wound dressing. Each gram of LDO Plus contains 4% Lidocaine HCl USP (40mg).

Traumatized mucosa, secondary bacterial infection of the area of proposed application and known hypersensitivity to any of the components.
Lidocaine Hydrochloride USP is contraindicated in patients with a known history of hypersensitivity to local anesthetics of the amide type.

For External Use Only. Avoid Contact with Eyes. If irritation or sensitivity occurs or infection appears, discontinue use and institute appropriate therapy.
LDO Plus should be used with caution in ill, elderly, debilitated patients and children who may be more sensitive to the systemic effects of Lidocaine Hydrochloride USP.

Most common adverse reactions are redness or swelling at the application site. Less common side effects, such as sluggishness, confusion, slow breathing, low blood pressure, or slow heartbeat, may occur. To report SUSPECTED ADVERSE REACTIONS, contact Gensco Pharma at 866-608-6284 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Prilocaine, Bupivacaine, Amyl nitrates/sodium nitrate/sodium thiosulfate, Dofetilide. Lomitapide, Beta-blockers (e.g., atenolol), Cimetidine, or Class 1 antiarrhythmic drugs (ex. Mexiletine). This may not be a complete list of all interactions that may occur. Ask your health care provider if LDO Plus may interact with other medicines that you take.

Use in Pregnancy: Teratogenic Effects - Pregnancy Category B.
Nursing Mothers: It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when Lidocaine Hydrochloride USP is administered to a nursing woman.
Pediatric use: Dosage in children should be reduced, commensurate with age, body weight and physical condition.
Geriatric use: No overall clinical differences in safety or effectiveness have been observed between the healthy elderly and other adult patients.

WARNING | 1 INDICATIONS AND USAGE | 2 DOSAGE AND ADMINISTRATION 2.1 Dosage for children 2.2 Administration | 3 DOSAGE FORMS AND STRENGTHS | 4 CONTRAINDICATIONS | 5 WARNINGS AND PRECAUTIONS | 6 ADVERSE REACTIONS 6.1 Central nervous system 6.2 Cardiovascular system 6.3 Allergic | 7 DRUG INTERACTIONS 7.1 Serious interactions 7.2 General interactions | 8 USE IN SPECIFIC POPULATIONS 8.1 Pregnancy 8.2 Labor and Delivery 8.3 Nursing Mothers 8.4 Pediatric Use 8.5 Geriatric Use | 9 OVER DOSAGE 9.1 Management of local anesthetic emergencies | 10 DESCRIPTION 10.0 Active Ingredients 10.2 Inactive Ingredients | 11 CLINICAL PHARMACOLOGY 11.1 Mechanism of Action 11.2 Onset of Anesthesia 11.3 Hemodynamics 11.4 Pharmacokinetics and Metabolism | 12 NONCLINICAL TOXICOLOGY 12.1 Carcinogenesis, Mutagenesis, Impairment of Fertility | 13 HOW SUPPLIED / STORAGE AND HANDLING
* Sections or subsections omitted from the prescribing information are not listed.

FOR EXTERNAL USE ONLY. NOT FOR OPHTHALMIC USE. EXCESSIVE DOSAGE, OR SHORT INTERVALS BETWEEN DOSES, CAN RESULT IN HIGH PLASMA LEVELS OF LIDOCAINE AND SERIOUS ADVERSE EFFECTS, PATIENTS SHOULD BE INSTRUCTED TO STRICTLY ADHERE TO THE RECOMMENDED DOSAGE AND ADMINISTRATION GUIDELINES AS SET FORTH IN THIS PACKAGE INSERT. THE MANAGEMENT OF SERIOUS ADVERSE REACTIONS MAY REQUIRE THE USE OF RESUSCITATIVE EQUIPMENT, OXYGEN, AND OTHER RESUSCITATIVE DRUGS.

Painful wounds such as post-surgical incisions, ulcers, cuts and abrasions.

Each pump of the LDO Plus MDOSE bottle (30mL Airless Metered Dose bottle) (NDC:35781-0500-3) will deliver 0.25 mL of LDO Plus (10 mg Lidocaine Hydrochloride USP), enough to cover a 2 inch by 2 inch area of skin. A single application should not exceed 4 pumps of the MDOSE bottle, equal to 1 gram of LDO Plus, (40 mg of Lidocaine Hydrochloride USP).
No more than 12 pumps of the MDOSE bottle, approximately 3 grams of LDO Plus (120 mg Lidocaine Hydrochloride USP,) should be administered in any one day.
Although the incidence of adverse effects with LDO Plus is quite low, caution should be exercised, particularly when employing large amounts, since the incidence of adverse effects is directly proportional to the total dose of local anesthetic agent administered.

LDO Plus is a topical medicated hydrogel wound dressing. Each gram of LDO Plus contains 4% Lidocaine Hydrochloride USP (40mg).

Lidocaine Hydrochloride USP is contraindicated in patients with a known history of hypersensitivity to local anesthetics of the amide type or to other components of LDO Plus.
Do not use LDO Plus on traumatized mucosa or in the presence of secondary bacterial infection of the area of proposed application.

If irritation or sensitivity occurs or infection appears, discontinue use and institute appropriate therapy. LDO Plus should be used with caution in ill, elderly, debilitated patients and children who may be more sensitive to the systemic effects of Lidocaine Hydrochloride USP. In case of accidental ingestion get medical help or contact poison control center right away.

Adverse experiences following the administration of Lidocaine Hydrochloride USP are similar in nature to those observed with other amide local anesthetic agents. These adverse experiences are, in general, dose-related and may result from high plasma levels caused by excessive dosage or rapid absorption, or may result from a hypersensitivity, idiosyncrasy or diminished tolerance on the part of the patient. Serious adverse experiences are generally systemic in nature. The following types are those most commonly reported:

7.1 Serious interactions: Antiarrhythmic Drugs: LDO Plus 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. Bupivacaine liposome: Lidocaine Hydrochloride USP increases toxicity of Bupivacaine by increasing the free (unencapsulated) bupiacaine. Dofetilide: Lidocaine Hydrochloride USP increases effects of dofetilide thru pharmacodynamic synergism. Lomitapide: Lidocaine Hydrochloride USP increases levels of lomitapide by affecting hepatic/intestinal enzymes CYP3A4 metabolism.

8.1 Use in Pregnancy: Teratogenic Effects of Lidocaine Hydrochloride USP. Pregnancy Category B. Reproduction studies have been performed in rats at doses up to 6.6 times the human dose and have revealed no evidence of harm to the fetus caused by Lidocaine Hydrochloride USP. There are, however, no adequate and well-controlled studies in pregnant women. Animal reproduction studies are not always predictive of human response. General consideration should be given to this fact before administering Lidocaine Hydrochloride USP to women of childbearing potential, especially during early pregnancy when maximum organogenesis takes place.

Acute emergencies from local anesthetics are generally related to high plasma levels encountered during therapeutic use of local anesthetics. (see ADVERSE REACTIONS, WARNINGS, and PRECAUTIONS).

10.1 Active Ingredients: Each gram of LDO Plus contains Lidocaine Hydrochloride USP 4% (40 mg). Lidocaine Hydrochloride USP is chemically designated as acetamide, 2- (diethylamino)-N-(2,6-dimethylphenyl), and has the following structure:

11.1 Mechanism of action:LDO Plus is a hydrated polymer (Hydrogel) wound dressing containing 4% w/w Lidocaine HCl USP. By providing moisture to the wound, LDO Plus creates a moist healing environment, which promotes granulation, epithelialization, and autolytic debridement. The high water content of hydrogel dressings cools the wound, producing pain relief that can last up to 6 hours. Dressing-change discomfort is also reduced because LDO Plus doesn’t adhere to the wound surface.
LDO Plus releases Lidocaine Hydrochloride USP from the Neutral (pH 7-7.2) hydrogel to stabilize the neuronal membrane by inhibiting the ionic fluxes required for initiation and conduction of impulses, thereby effecting local anesthetic action.

Studies of Lidocaine Hydrochloride USP in animals to evaluate the carcinogenic and mutagenic potential or the effect on fertility have not been conducted.

HOW SUPPLIED:LDO Plus (Medicated Hydrogel containing Lidocaine HCl USP 4%)
1.0 oz (28.5g) 30mL Airless Pump - NDC 35781-0500-3
STORE AND DISPOSE OF THIS AND ALL MEDICATIONS OUT OF REACH OF CHILDREN AND PETS. All prescriptions using this product shall be pursuant to state statutes as applicable. This product may be administered only under a physician’s supervision. There are no implied or explicit claims on the therapeutic equivalence. Store at 25ºC (77ºF); excursions permitted to 15º-30ºC (59º-86º F). See USP Controlled Room Temperature. Protect from freezing.
Manufactured for: Gensco Laboratories, 8550 NW 33rd Street, Suite 200, Doral, FL 33122
MDOSE™ is aregistered trademark of Gensco Laboratories, LLC.

Methyl Salicylate....30.00%
Menthol.................10.00%

temporarily relieves the minor aches and pains of muscles and joints associated with:
-simple backache -arthritis -strains -bruises -sprains

For external use only

- use only as directed
- adults and children 12 years of age and older:
apply to affected area not more than 3 to 4 times daily
- children under 12 years of age: ask a doctor

Aloe Barbadensis Leaf (Aloe Vera Gel) Juice, Aqua (Deionized Water), Arnica Montana Flower Extract, Boswellia Serrata Extract, Calendula Officinalis Extract, Cannabis Sativa (Hemp) Seed Oil, Cetearyl Olivate, Cetyl Alcohol, Chondrotin Sulfate, Gluconolactone, Glucosamine Sulfate, Glycerin, Glyceryl Stearate, Helianthus Annuus (Sunflower) Oil, Magnesium Sulfate, Methylsulfonylmethane (MSM), Sodium Benzoate, Sodium Laurylglucosides Hydroxypropylsulfonate, SorbitanOlivate, Tapioca Starch, Xanthan Gum, Zemea (Corn) Propanediol.