Otc - Active Ingredient
Lidocaine 4%
Lidocaine Pain Relieving Gel-patch
FDA Label NDC 87125-001
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Nanjing Anxing Medical Technology Co., Ltd. for the product Lidocaine Pain Relieving Gel-patch (NDC 87125-001). 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 anesthetic
Indications & Usage
Temporarily relieves minor pain
associated with:
arthritis
simple backache
muscle strains
sprains
bruises
Warnings
For external use only
Otc - Do Not Use
on wounds or damaged, broken or irritated skin
with a heating pad
if you are allergic to any ingredients of this product
Otc - When Using
Use only as directed
Do not bandage tightly
Avoid contact with eyes and mucous membranes
Temporary burning or redness at application site may occur
Rare cases of serlous burns have been reported with products of this type
Otc - Stop Use
condition worsens or symptoms persist for more than 7 days
symptoms clear up and occur again within a few days
severe burning sensation, itching, rash or skin irritation develops
If pregnant or breast-feeding, ask a health professional before use.
Otc - Keep Out Of Reach Of Children
Used patches contain a large amount of lidocaine. lf swallowed, get medical help or contact a Poison Control Center right away (1-800-222-1222).Accidental exposure in children can result in death.
Dosage & Administration
Adults and children 12 years of age and over:
clean and dry affected area
remove film from patch and apply to the skin
apply one patch at a time to affected area
use 1 patch for up to 8 hours
do not use more than 3 to 4 times daily
Children under 12 years of age: consult
a doctor
Inactive Ingredient
WATER
POLYVINYL ALCOHOL
PHENOXYETHANOL
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Label (Label)
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