Otc - Active Ingredient
Lidocaine 4%
Frnxuc Lidocaine Patches Patch
FDA Label NDC 87204-211
11 label sections · Submitted to the FDA by Guangzhou Huixue Biotechnology Co., Ltd. · Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Guangzhou Huixue Biotechnology Co., Ltd. for the product Frnxuc Lidocaine Patches (NDC 87204-211). 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, inactive ingredient, otc - purpose, indications & usage, warnings, otc - keep out of reach of children, otc - when using, otc - do not use, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Inactive Ingredient
Aluminum glycinate, glycerin, kaolin, polyacrylic acid,
polysorbate 80, polyvinylpyrrolidone, sodium polyacrylate,
tartaric acid, titanium dioxide, water.
Otc - Purpose
Temporarily relieves minor aches and pains of muscles and joints associated with simple backache, strains, sprains and bruises.
Indications & Usage
Temporarily relieves minor aches and pains of muscles and joints associated with simple backache, strains, sprains and bruises. Adults and children 12 years and over: Clean and dry the affected area. Remove the backing film from the patch. Apply the adhesive side to the affected area • Use 1 patch at a time. -Remove patch after no more than 12 hours of application. Do not reuse the patch. Children under 12 years: Ask a doctor.
Warnings
For external use only. Do not use • more than 1 patch at a time. • on wounds or damaged, broken, irritated or swollen skin. on puncture wounds. with a heating pad or other local heat. -if you are allergic to any ingredients of this product. • at the same time as other topical anesthetics or topical analgesics. . if pouch is opened or damaged.
Otc - Keep Out Of Reach Of Children
Store at 20°C to 25°C (68°F to 77°F). . Protect from excessive heat, moisture and direct sunlight. • Do not freeze. - Do not use if individual pouch is opened or damaged. -Tightly reseal pouch containing unused patches.
Otc - When Using
DI Adults and children 12 years and over: Clean and dry the affected area. Remove the backing film from the patch. Apply the adhesive side to the affected area. Use 1 patch at a time. .Remove patch after no more than 12 hours of application. ·Do not reuse the patch. Children under 12 years: Ask a doctor.
Otc - Do Not Use
Do not use • more than 1 patch at a time. • on wounds or damaged, broken, irritated or swollen skin. on punceons with a heating pad or other local heat. iyagicoaigtshisproct at the same time as other topical anesthetics or topical analgesics. .if pouch is opened or damaged.
Otc - Stop Use
Stop use and ask a doctor if . skin reactions occur, such as rash, itching, redness, irritation, pain, swelling or blistering. coss . symptoms persist for more than 7 days. -symptoms clear up and occur again within a few days. If pregnant or breast-feeding, ask a health professional before use. Keep out of reach of children and pets. If swallowed, get medical help or contact a Poison Control Center right away.
Dosage & Administration
Adults and children 12 years and over: Clean and dry the affected area. Remove the backing film from the patch. Apply the adhesive side to the affected area • Use 1 patch at a time. -Remove patch after no more than 12 hours of application. Do not reuse the patch. Children under 12 years: Ask a doctor.
Package Label.Principal Display Panel
Frnxuc Lidocaine patches
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