Label: LIDOCAINE HYDROCHLORIDE- lidocaine gel
- NHRIC Code(s): 35781-0500-1, 35781-0500-3, 35781-0500-9
- Packager: Gensco Laboratories, LLC
- Category: HUMAN PRESCRIPTION DRUG LABEL
- DEA Schedule: None
- Marketing Status: Premarket Notification
Drug Label Information
Updated October 1, 2015
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- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- DESCRIPTION
- INDICATIONS AND USAGE
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CONTRAINDICATIONS
LDO Plus contains Lidocaine Hydrochloride USP and 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.
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WARNINGS
Do not use this product if you are allergic to any ingredients. If condition worsens or does not improve within 7 days, consult a physician. Do not use on children under 2 years of age without consulting a physician.
Avoid contact with eyes. Do not use in large quantities.For external use only. Not for ophthalmic use.
Keep out of reach of children.
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PRECAUTIONS
If irritation or sensitivity occurs or infection appears, discontinue use and institute appropriate therapy. LDO Plus Hydrogel 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.
CARCINOGENESIS, MUTAGENESIS, AND IMPAIRMENT OF FERTILITY
Studies of lidocaine in animals to evaluate the carcinogenic potential of the effect on fertility have not been conducted.
USE IN PREGNANCY
Teratogenic Effects:
Teratogenic Effects. 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.
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. Caution must be taken to avoid over dosage when applying LDO Plus to large areas of injured or abraded skin, since the systemic absorption of Lidocaine Hydrochloride USP may be increased under such conditions.
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ADVERSE REACTIONS:
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:Central Nervous System:
CNS manifestations are excitatory and/or depressant and may be characterized by lightheadedness, 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. The excitatory manifestations may be very brief or may not occur at all, in which case the first manifestation of toxicity may be drowsiness merging into unconsciousness and respiratory arrest. Drowsiness following the administration of lidocaine is usually an early sign of a high blood level of the drug and may occur as a consequence of rapid absorption.
Cardiovascular system
Cardiovascular manifestations are usually depressant and are characterized by bradycardia, hypotension, and cardiovascular collapse, which may lead to cardiac arrest.
Allergic
Allergic reactions are characterized by cutaneous lesions, urticaria, edema or anaphylactoid reactions. Allergic reactions may occur as a result of sensitivity either to the local anesthetic agent or to other components in the formulation. Allergic reactions as a result of sensitivity to lidocaine are extremely rare and, if they occur, should be managed by conventional means. The detection of sensitivity by skin testing is of doubtful value.
- DOSAGE AND ADMINISTRATION:
- STORAGE AND HANDLING
- HOW SUPPLIED
- LIDOCAINE HCL (LIDOCAINE HCL ) HYDROGEL
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INGREDIENTS AND APPEARANCE
LIDOCAINE HYDROCHLORIDE
dressing, wound and burn, hydrogel w/drug and/or biologic gelProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NHRIC:35781-0500 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987) LIDOCAINE 40 mg in 1 g Inactive Ingredients Ingredient Name Strength FILIPENDULA ULMARIA FLOWER (UNII: 06L18L32G6) QUERCUS ALBA WOOD (UNII: XR6BC2ZUAM) POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ) POLYETHYLENE GLYCOL 3350 (UNII: G2M7P15E5P) WATER (UNII: 059QF0KO0R) ZINC ACETATE (UNII: FM5526K07A) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NHRIC:35781-0500-1 1 in 1 CARTON 1 15 g in 1 TUBE; Type 9: Other Type of Part 3 Combination Product (e.g., Drug/Device/Biological Product) 2 NHRIC:35781-0500-3 1 in 1 CARTON 2 30 g in 1 TUBE; Type 9: Other Type of Part 3 Combination Product (e.g., Drug/Device/Biological Product) 3 NHRIC:35781-0500-9 1 in 1 CARTON 3 90 g in 1 TUBE; Type 9: Other Type of Part 3 Combination Product (e.g., Drug/Device/Biological Product) Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date Premarket Notification K092086 06/30/2009 Labeler - Gensco Laboratories, LLC (831042325) Registrant - Gensco Laboratories, LLC (831042325) Establishment Name Address ID/FEI Business Operations Gensco Laboratories, LLC 831042325 manufacture(35781-0500)
