Active Ingredient
Mentho1 4%
Neuropathy Cream
FDA Label NDC 83570-001
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Owell Naturals Brand, Llc for the product Neuropathy Cream (NDC 83570-001). 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 active ingredient, purpose, uses, do not use, when using this product, stop use and ask a doctor if, keep out of reach of children, directions, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Extenal Analgesic
Uses
Temporarily relieves minor aches and pains of muscles and joints.
Do Not Use
On wound or Damage skin
When Using This Product
do not get into eyes or mucous membranes
do not bandage tightly
Stop Use And Ask A Doctor If
condition worsens
symptoms persist for more than 7 days or clear up and occur again within a few days
Keep Out Of Reach Of Children
If swallowed, get medical help or contact a Poison Control Center right away.
Directions
adults and children 12 years of age and older:
apply to affected area no more than 3 to 4 times daily
children under 12 years of age:
ask a doctor
Questions?
Questions or comments?
Call 1-800-XXX-XXXX
Manufactured for: Your Company Name
City, State, ZIP
Warnings
For external use only.
Do not use on:
• Broken skin
• Wounds
• Irritated skin
When using this product:
• Avoid contact with eyes and mucous membranes
• Do not bandage tightly
• Do not apply heat to the treated area
Stop use and ask a doctor if:
• Condition worsens
• Symptoms persist for more than 7 days
• Redness or irritation develops
Keep out of reach of children.
If swallowed, get medical help or contact a Poison Control Center right away.
Inactive Ingredients: Purified Water, Glycerin
none
Principal Display Panel
Neuropathy Cream
Menthol 1%
Topical Analgesic
Net Wt. XX oz (XX g)
For external use only
Distributed by:
Owell Naturals Brand, LLC
USA
See product
Principal Display Panel (Neuropathy Label)
Principlal Display Panel
see product image
Principal Display Panel (Neuropathy Label)
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