Otc - Active Ingredient
Lidocaine 4%
4% Lidocaine Patch
FDA Label NDC 84735-010
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Hengyang Chuangjiujia Trading Co., Ltd. for the product 4% Lidocaine Patch (NDC 84735-010). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding otc - active ingredient, otc - purpose, indications & usage, warnings, otc - do not use, otc - when using, otc - stop use, otc - keep out of reach of children, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Purpose
Topical Aneslhetic
Indications & Usage
Use Temperarily relicwes miner pain.
Warnings
For external use only
Otc - Do Not Use
Do not use More than one patch on your body at a time On gut, initated orswollen gkin On puncture wounds For more than one week without consultinga doctor if you are allergic to any aclive or inactive ingrediantsm lf pouch iscambged or opred.
Otc - When Using
When using this product Use only as directed Read and follow all directionsand warings on this carton Do not allow oontact with the oyes Do not use atthe same lime as oler bopical analgesics Do nat bandage lighlly or apoly localheat (such as heating pads, to the area of use Dispose of uged patch inmannerihat always keeps product away irom children and pots, Lised paiches siilcontain the drug product that can produce gerious adverge elfecis if a child or petchaws or ingasis ihis patchh.
Otc - Stop Use
Stop use and consult a doctor if condtion worsensm Redness is presert lniation develops Sympioms persist for more than 7 dlays or clear up and oocuragain willin a ferw darys You coperienoe signs of skin injury, such as pain, sweling or bllslering where the product was applled.
Otc - Keep Out Of Reach Of Children
Keep out of reach of children and pets.
Dosage & Administration
Adults and chldren 12 years of age and over: Clean and dry affected areaCarefully remove backing from patchstarting at a corner. Apply sticky sideof patch to affected area. Use one patch for up to 12 hours. Discard patchaftersingle use. Children under 12 years of age: consult a physician.
Inactive Ingredient
Aluminum Glycinate
Aluminum Hydroxide
Cellulose Gum (Sodium CMC)
DMDM Hydantoin
Glycerin
Polyacrylic Acid
Polysorbate 80
Propylene Glycol
Ricinus Communis (Castor) Seed Oil
Silica (Colloidal)
Sodium Polyacrylate
Tartaric Acid
Titanium Dioxide
Urea
Water (Purified Water)
Package Label.Principal Display Panel
Label (Label1)
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