lidocaine, dimethicone
Drug Details
- Generic Name
- lidocaine, dimethicone
- Brand Names
- DermacinRx ZRM Pak
- Application Number
- Sponsor
- PureTek Corporation
- NDC Codes
- 1
- Dosage Forms
- KIT
- Routes
- N/A
- Active Ingredients
- N/A
Indications and Usage
INDICATION AND USAGE Lidocaine patch 5% is indicated for relief of pain associated with post-herpetic neuralgia. It should be applied only to intact skin.
Uses ■ for the treatment and/or prevention of diaper rash ■ temporarily protects and helps relieve chapped or cracked skin
Warnings
WARNINGS Accidental Exposure in Children Even a used lidocaine patch contains a large amount of lidocaine (at least 665 mg). The potential exists for a small child or a pet to suffer serious adverse effects from chewing or ingesting a new or used lidocaine patch, although the risk with this formulation has not been evaluated. It is important for patients to store and dispose of lidocaine patch 5% out of the reach of children, pets and others. (See HANDLING AND DISPOSAL ) Excessive Dosing Excessive dosing by applying lidocaine patch 5% to larger areas or for longer than the recommended wearing time could result in increased absorption of lidocaine and high blood concentrations, leading to serious adverse effects (see ADVERSE REACTIONS , Systemic Reactions ). Lidocaine toxicity could be expected at lidocaine blood concentrations above 5 mcg/mL. The blood concentration of lidocaine is determined by the rate of systemic absorption and elimination. Longer duration of application, application of more than the recommended number of patches, smaller patients, or impaired elimination may all contribute to increasing the blood concentration of lidocaine. With recommended dosing of lidocaine patch 5%, the average peak blood concentration is about 0.13 mcg/mL, but concentrations higher than 0.25 mcg/mL have been observed in some individuals.
Warnings For external use only Do not use on ■ deep or puncture wounds ■ animal bites ■ serious burns When using this product ■ do not get into eyes Stop use and ask a doctor if ■ condition worsens ■ symptoms last more than 7 days or clear up and occur again within a few days Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.