Other
LIDOCAINE PATCH
Pain Relieving Patch
FDA Label NDC 84273-001
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Hunan En Pu Pharmaceutical Co., Ltd. for the product Pain Relieving Patch (NDC 84273-001). 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 other, otc - active ingredient, otc - purpose, indications & usage, warnings, otc - do not use, otc - when using, otc - stop use, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Active Ingredient
Lidocaine 4%
Otc - Purpose
Topical anesthetic
Indications & Usage
For the temporary relief of pain
Warnings
For external use only
Otc - Do Not Use
more than 1 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
Otc - When Using
use only as directed. Read and follow all directions and warnings on this carton.
do not allow contact with the eyes
heat (such as heating pads) to the area of use
do not use at the same time as other topical analgesics
dispose of used patch in manner that always keeps product away from children and pets.
Used patches stll contain the drug product that can produce serious adverse effects if a child or pet chews or ingests this patch.
Otc - Stop Use
condition worsens
symptoms persist for more than 7 days or clear up and occur again within a few days
redness or irritation develops
you experience signs of skin injury, such as pain, sweling, or blistering where
the product was applied
Otc - Keep Out Of Reach Of Children
Keep out of reach of children. lf swallowed, get medical help or contact a Poison Control Center right away
Dosage & Administration
Adults and children 12 years of age and older:
Wash and dry the affected area.
Peel off the backing film from one side of the patch carefully
Apply the exposed portion of the patch to the affected area.
Gently press the patch with your hand to fit the affected area completely.
Do not exercise vigorously during use to prevent the patch from falling off.
Use only 1 patch for a maximum of 8 hours.
Children under 12 years of age: Ask a doctor before use
Storage And Handling
store at room temperature 15°-30C (59-86F).
Inactive Ingredient
aluminum glycinate
glycerin
methyl acrylate
polyacrylic acid
polysorbate 80
propylene glycol
sodium polyacrylate
tartaric acid
poval
alcohol
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Label (Label1)
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