Otc - Active Ingredient
Lidocaine 4%
Menthol 1%
Sumifun Plantar Relief Roll -on Gel
FDA Label NDC 84165-015
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Guangzhou Zhupuyou E-commerce Co., Ltd for the product Sumifun Plantar Relief Roll -on (NDC 84165-015). 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 muscle soreness and minor jointpains in the wrist, knees, back, neck, hips, shoulders,elbows.
Warnings
For external use only
Otc - Do Not Use
on wounds or on irritated or damaged skin
with a heating pad or device
with other ointments, creams, sprays, or liniments
if your are allergic to any ingredients of this product
Otc - When Using
use only as directed
avoid contact with the eyes, mucous membranes, or rashes
do not bandage tightly
do not expose the area to local heat or to direct sunlight
Otc - Stop Use
skin reactions such as redness,swelling, blistering or other discomfort occur
condition worsens or symptoms persist for more than7 days
symptoms clear up and occur again within a few days
redness is present or excessive skin irritation occurs
Otc - Keep Out Of Reach Of Children
If swallowed accidentally,get medicalhelp or contact with Poison ControlCenter immediately
Dosage & Administration
Adults and Children above 12 years old:
apply a thin layer to affected area every 6 to 8 hours, not more than 3 to 4 times daily
massage until thoroughly absorbed into skin
wash hands thoroughly with soap and water after each use
children under 12 years of age: ask adoctor
Inactive Ingredient
.ALPHA.-TOCOPHEROL, D-
Aloe Vera Extract
Carbomer
Isopropyl myristate
Lavender Oil
Phenoxyethanol
Polysorbate 80
Propylene Glycol
Tartaric acid
Water
Package Label.Principal Display Panel
Label (Label)
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