Other
LIDOCAINE PATCH 4%
Pain Reliveing Patch
FDA Label NDC 81484-601
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Anhui Miao De Tang Pharmaceutical Co., Ltd. for the product Pain Reliveing Patch (NDC 81484-601). 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% Topical anesthetic
Otc - Purpose
For the temporary relief of pain
Indications & Usage
LIDOCAINE PATCH to help Temporarily relteves minor pain
Warnings
For external use only
Do not use more than 1 patch on vour bodv at a time on cut, irritated.or swolen skin on puncture wounds
for more than one week without consulting a doctor
Otc - Do Not Use
use onlv as directed. Read and follow all directions and warnings on this carton. do not allow contact with the eyes
do not bandage tightly or apply local heat (such as heating pads) to the area of use do not use at the same time as other topical analcesics
dispose of used patch in 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.
Otc - When Using
use onlv as directed. Read and follow all directions and warnings on this carton. do not allow contact with the eyes
do not bandage tightly or apply local heat (such as heating pads) to the area of use do not use at the same time as other topical analcesics
dispose of used patch in 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.
lf pregnant or breast-feeding, ask a health professional before use.
Otc - Stop Use
condition worsens
symptoms persist for more than 7 days or clear up and occur again within a few days
redness or iritation develops you experience signs of skin injury, such as pain, swelling, or blistering where
the product was applied
Otc - Keep Out Of Reach Of Children
Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away(1-800-222-1222).
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°-30°C (59°-86°F)
Inactive Ingredient
aluminum glycinate, glycerin, methyl acrylate, polyacrylic acid, polysorbate 80, propylene glycol.
sodium polvacrylate, tartaric acid, poval, alcohol, water
Package Label.Principal Display Panel
Label (20230531134258)
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