Otc - Active Ingredient
Menthol 8%
Natureance Miracle Oil
FDA Label NDC 80465-008
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Eros Global Corp for the product Natureance Miracle (NDC 80465-008). 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, uses:, warnings, otc - when using, other safety information, otc - pregnancy or breast feeding, 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 Analgesic
Uses:
Aid for temporary local relief of minor pain in muscles or joints.
Warnings
For external use only.
Otc - When Using
Avoid contact with the eyes or mucous membranes.
Do not apply to wounds or damaged skin.
Do not apply to the irritated skin or if excessive irritation develops.
Do not bandage.
Do not use with heating pad or device.
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.
Other Safety Information
Keep away from fire or flame.
Otc - Pregnancy Or Breast Feeding
Ask a health professional before use.
Otc - Keep Out Of Reach Of Children
If swallowed, get medical help or contact a Poison Control Center right away.
Directions:
Adults and Children over 12 years:
Apply a small amount on the area to be.
Massaged in a circular motion, let set for a few seconds.
Repeat as necessary, but no more than 3 to 4 times daily.
Children under 12 years of age: Consult physician.
Other Information:
Store in a cool dry place with lid closed tightly.
Inactive Ingredient
Isopropyl Myristate, Parfum, Limonene.
* Please review the disclaimer below.
