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Drug Facts
Auvon Pain Relief Cream
FDA Label NDC 83391-009
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 Yuwen E-commerce Co., Ltd. for the product Auvon Pain Relief Cream (NDC 83391-009). 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 - 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 - Active Ingredient
Lidocaine 4%
Otc - Purpose
Topical Analgestic
Indications & Usage
For the temporay relief of pain
Warnings
Please read all directions and warnings as follows and use only as directed. For external use only.
Keep out of reach of children and pets. If ingested, get medical help right away.
Otc - Do Not Use
Do not use
if you're allergic to the listed ingredients.
if the package arrives damaged or opened.
if you are pregnant or breast-feeding.
at the same time as other topical analgesics.
on eyes, mucous membranes, cuts, wounds damaged, broken, swolen. or irritated skin.
In large quantities. particularly over raw surfaces or blistered area
Otc - Stop Use
Stop use and ask a doctor
if symptoms persist for more than / days or clear up and occur again within a few davs.
if you experience any signs of deterioration or skin iniurv. such as redness, irritation, sweling, or bistering.
Otc - Keep Out Of Reach Of Children
Keep out of reach of children and pets. If ingested, get medical help right away.
Dosage & Administration
Apply a thin layer to the affected area every 6 to 8 hours.
Children under 12 years of age:do not use, consult a doctor.
Use no more than three times in a day.
Wash hands after use.
Storage And Handling
Store it in a dry place at room temperature between 20-25°C (68-77°F) and away from direct sunlight.
Inactive Ingredient
Aloe oil, Carbomer 940, Ethyl Alcohol, Ethyl Paraben, Glycerin, Lavander oil,
Menthol, Polysorbate 80, Trolamine, Water
Package Label.Principal Display Panel
83391-009-03 (83391 009 03)
83391-09-02 (83391 009 02)
83391-009-01 (83391 009 01)
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