Otc - Active Ingredient
Menthol 5%
Non-proprietary Name Patch
FDA Label NDC 87915-789
9 label sections · Submitted to the FDA by Nanjing 3h Medical Products Co.,ltd. · Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Nanjing 3h Medical Products Co.,ltd. for the product Non-proprietary Name (NDC 87915-789). 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, warnings, indications & usage, otc - keep out of reach of children, other safety information, inactive ingredient, dosage & administration, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Purpose
Topical analgesic
Warnings
For external use only.
When using this product
use only as directed
do not bandage tightly
avoid contact with the eyes or on mucous membranes
Do not use
on wounds, damaged skin, rashes, swollen skin, or blistered areas
with a heating pad or apply local heat to the area of use
Stop use and ask a doctor if
condition worsens, or if symptoms persist for more than 7 days or clear up and occur again within a few days
you experience pain, swelling or blistering of the skin
If pregnant or breast-feeding, ask a health professional before use.
Keep out of reach of children and pets. Call a Poison Control Center immediately if overdose or accidental ingestion occurs.
Indications & Usage
• adults and children 12 years of age and older: Remove backing paper, apply to clean dry skin (temples or tension points), wear up to 8 hours, and discard after use.
• apply to affected area not more than 3 to 4 times daily
Otc - Keep Out Of Reach Of Children
children under 12 years of age: do not use, consult a physician
Other Safety Information
store in a cool dry place away from direct sunlight
Inactive Ingredient
Camellia Sinensis Leaf Extract, Disodium EDTA, Ethanol, Glycerin, Magnesium Chloride, Sodium Polyacrylate, Tartaric Acid, Water
Dosage & Administration
Menthol 5%
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