Otc - Active Ingredient
Lidocaine 4.0%
4% Lidocaine Patches Patch
FDA Label NDC 87794-008
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Shenzhen Chaoxiji Technology Co.,ltd. for the product 4% Lidocaine Patches (NDC 87794-008). 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, purpose, use, warnings, when using this product, do not use, stop use and consult a doctor if, 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
Purpose
Topical Anesthetic
Use
Temporarily relieves minor pain.
Warnings
For external use only
When Using This Product
▪Use only as directed
▪Read and follow all directions and warnings on this carton
▪Do not allow contact with the eyes DO not use at the same time as other topical analgesics
▪Do not bandage tightly or apply local heat (such as heating pads) to the area of use
▪ Dispose of used patch in a manner that always keeps product away from children and pets, used patches still contain the drug product that can produce serious adverse effects if a child or pet chews or ingests this patch.
Do Not Use
▪More than one patch on your body at a time
▪On cut, irritated or swollen skin
▪On puncture wounds
▪For more than one week without consulting a doctor
▪If you are allergic to any active or inactive ingredients
▪If pouch is damaged or opened.
Stop Use And Consult A Doctor If
▪Condition worsens
▪Redness is present
▪Irritation develops
▪Symptoms persist for more than 7 days or clear up and occur again within a few days
▪You experience signs of skin injury, such as pain, swelling or blistering where the product was applied.
If pregnant or breastfeeding, ask a health professional before use.
Otc - Keep Out Of Reach Of Children
Keep out of reach of children and pets.
Directions
Adults and children 12 years of age and over: Clean and dry affected area.Carefully remove backing from patch starting at a corner. Apply sticky side of patch to affected area. Use one patch for up to 12 hours. Discard patch after single use.Children under 12 years of age: consult a physician.
Other Information
Store in a clean, dry place outside of direct sunlight. Protect product from excessive moisture.
Inactive Ingredients
Aluminum Glycinate, Aluminum Hydroxide, Cellulose Gum, DMDM Hydantoin, Glycerin, Polyacrylic Acid, Polysorbate 80, Propylene Glycol, Ricinus Communis Seed Oil (castor), Silica, Sodium Polyacrylate, Tartaric Acid, Titanium Dioxide, Urea, Water
Package Label.Principal Display Panel
Package Label:
87794-008-01 (87794 008 01)
* Please review the disclaimer below.
