Lidocaine Hydrochloride Solution
Product Images NDC 0116-4027

Product Visual Gallery

This gallery contains 23 technical images submitted to the FDA as part of the official labeling for Lidocaine Hydrochloride (NDC 0116-4027). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by Xttrium Laboratories, Inc., these visuals offer a comprehensive scientific overview of the product's physical and chemical identity, aiding pharmacists and researchers in product verification and study.

FDA Label Image

Bottle Label (Bottle 1)

This is a drug facts and warning label for Lidocaine Hydrochloride Oral Topical Solution, USP 2% (Viscous). It includes a boxed warning about life-threatening and fatal events in infants and young children, and general safety instructions for use, storage, and administration of the product. The description specifies it is a local anesthetic applied topically for mucous membranes in the mouth and pharynx, for oral use only.*

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Bottle Label (Bottle 10)

This image shows a text panel detailing adverse reactions, overdose information, and management of local anesthetic emergencies for Lidocaine hydrochloride solution. It covers cardiovascular manifestations, allergic reactions, overdose warnings, and steps for monitoring and managing patient safety during local anesthetic administration, including ventilation support guidelines.*

FDA Label Image

Bottle Label (Bottle 11)

A drug facts and administration instructions panel for Lidocaine Hydrochloride solution. It covers emergency treatment recommendations for convulsions and cardiovascular depression, dosage and administration guidelines for adults using the oral topical solution, and details on the lethality dose in animal studies. The text emphasizes proper dose limits and usage methods for symptomatic treatment of irritated mucous membranes.*

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Bottle Label (Bottle 12)

Text panel from the Lidocaine hydrochloride Oral Topical Solution label providing pediatric dosage instructions and precautions. It instructs careful dosing for children based on age and weight, specifies maximum doses for different age groups, and describes the product's packaging as a 4 fl oz (118 mL) polyethylene squeeze bottle with a 100 mL fill.*

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Bottle Label (Bottle 13)

A text panel providing recommended storage instructions for Lidocaine hydrochloride solution, including temperature ranges and a warning to avoid freezing. Additional instructions indicate to shake well before using and to dispense in a child-resistant container. It states the product is Rx only and includes manufacturer and labeler details for Xttrium Laboratories, Inc. and GROUPE PARIMA Inc.*

FDA Label Image

Bottle Label (Bottle 14)

Label for Lidocaine Hydrochloride Oral Topical Solution USP 2% (viscous) by Xttrium Laboratories, Inc., NDC 0116-4027-10. The solution contains less than 0.1% alcohol, is for oral use only, and comes in a 100 mL package. The label includes usage cautionary statements and warnings.*

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Bottle Label (Bottle 2)

Chemical structure of lidocaine hydrochloride monohydrate, showing the molecular formula C14H22N2O with HCl and H2O as part of the composition. The image includes a detailed line drawing of the molecular structure with labeled atoms and bonds, as well as accompanying text describing the molecular formula and weight.*

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Bottle Label (Bottle 3)

This text panel covers the pharmacokinetics and metabolism of lidocaine hydrochloride, discussing its absorption, plasma binding, metabolism, and excretion after topical and gastrointestinal administration, as well as its effects on cardiovascular hemodynamics and the biotransformation pathways of its metabolites.*

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Bottle Label (Bottle 4)

Drug information panel for Lidocaine Hydrochloride Oral Topical Solution, USP 2%, detailing pharmacokinetics, indications and usage for topical anesthesia, contraindications including hypersensitivity, and warnings about dosage and adverse effects. The text emphasizes cautious use and adherence to administration guidelines.*

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Bottle Label (Bottle 5)

This image is a text panel discussing safety warnings for Lidocaine Hydrochloride Oral Topical Solution, USP 2%. It covers serious adverse reactions, including life-threatening events in infants and young children, and risks of methemoglobinemia. The text advises caution and outlines specific conditions and patient groups at risk when using this product.*

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Bottle Label (Bottle 6)

Text panel from a Lidocaine hydrochloride oral and topical solution label discussing precautions for patients. It includes warnings about measuring doses accurately for children under 3, recommended use only as prescribed, storage instructions, signs of systemic toxicity, and disposal advice to prevent exposure to children and pets.*

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Bottle Label (Bottle 7)

This text panel provides warnings and precautions for use of Lidocaine hydrochloride oral topical solution 20 mg/mL. It highlights risks such as impaired swallowing, aspiration, methemoglobinemia, and biting trauma associated with topical anesthetics, especially in children. It emphasizes proper dosage, patient tolerance considerations, and avoidance in patients with certain allergies or conditions.*

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Bottle Label (Bottle 8)

A drug interaction information panel for lidocaine hydrochloride solution describing increased risk of methemoglobinemia when local anesthetics are combined with certain drugs. It includes a table listing drug classes and examples associated with methemoglobinemia, such as nitrates/nitrites, local anesthetics, antineoplastic agents, antibiotics, antimalarials, anticonvulsants, and other drugs. Additional text addresses carcinogenesis, mutagenesis, impairment of fertility, and teratogenic effects during pregnancy.*

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Bottle Label (Bottle 9)

A detailed text panel discussing pediatric use and adverse reactions of lidocaine hydrochloride. It covers dosage adjustments for children and lists potential adverse effects, focusing on central nervous system symptoms linked to lidocaine administration, including excitatory and depressive manifestations, and their clinical significance.*

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Insert (Insert 2)

Text panel describing Lidocaine hydrochloride oral topical solution 2% (viscous), including its chemical structure, molecular formula, composition, mechanism of action, pharmacokinetics, metabolism, clinical pharmacology, indications, and contraindications. The panel details the drug's usage for topical anesthesia and its formulation components.*

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Insert (Insert 4)

Text panel detailing safety warnings and precautions for Lidocaine Hydrochloride Oral Topical Solution 20 mg/mL by Xttrium Laboratories, Inc. It includes warnings about topical anesthetic use in the mouth/throat, potential for methemoglobinemia, drug interactions, carcinogenicity, pregnancy, nursing considerations, and pediatric dosing recommendations.*

FDA Label Image

Ud Cup Lid (Lidocaine Lid)

Label of Lidocaine Hydrochloride Oral Topical Solution USP 2% (Viscous) in a 15 mL unit dose container. The label indicates it is for oral use only, with instructions to shake well before use. The product is manufactured by Xttrium Laboratories, Inc., Mount Prospect, IL, and is marked Rx only.*

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Bottle Label (Lidocaine Bottle)

Lidocaine hydrochloride oral topical solution USP 2% (viscous) 100 mL bottle label. The label indicates the product is alcohol less than 0.1%, for oral use only, and cautions against use if the tamper-evident seal is broken or missing. The labeler is Xttrium Laboratories, Inc., and the NDC is 0116-4027-10.*

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Insert (Insert 1)

The label for Lidocaine Hydrochloride Oral Topical Solution USP 2% (Viscous) is displayed. It specifies the product as a 2% solution for oral and topical use, indicated for prescription use only. The label includes a barcode, the proprietary name, and warnings about life-threatening events in infants and young children. The product is labeled for oral use only and stresses following prescribed dosing instructions. The labeler is not explicitly visible in the image.*

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Insert (Insert 3)

This text panel provides WARNINGS, including risks of overdose and serious adverse effects for Lidocaine Hydrochloride Oral Topical Solution, USP 2%. It details life-threatening risks for infants and young children, methemoglobinemia risks, and precautions for patient care, especially for children under 3 years old. Instructions for storage, accurate dosing, and safety are included for patients and caregivers.*

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Insert (Insert 5)

Text panel detailing adverse reactions, overdose information, and dosage and administration instructions for Lidocaine hydrochloride oral topical solution. It describes common and serious adverse effects on central nervous, cardiovascular, and allergic systems, management of local anesthetic emergencies, and recommended dosing guidelines for adults.*

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Insert (Insert 6)

Text panel providing pediatric dosing instructions, warnings about overdose risk, storage guidelines, and handling instructions for Lidocaine Hydrochloride Oral Topical Solution 2%. It includes directions for measuring and applying the solution, recommended storage temperatures, and manufacturer and labeler contact information.*

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Lidocaine 2% (Structural Formula)

Chemical structure of Lidocaine hydrochloride, showing its molecular arrangement with annotations for hydrochloride and water components. The structure includes aromatic rings, nitrogen, oxygen, and methyl groups.*

* About these descriptions: Image descriptions on this page are generated by automated AI analysis of the product label images from the manufacturer's FDA label submission (SPL). They are provided for reference only and may contain errors or omissions. Always rely on the printed label itself and the official FDA labeling, and consult a pharmacist or healthcare professional with any questions about this product.