Otc - Active Ingredient
Menthol 8%
Natureance Miracle Oil
FDA Label NDC 80465-008
10 label sections · Submitted to the FDA by Eros Global Corp · 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, otc - stop use, 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. ยท Ask a doctor before use if you have redness over affected area.
Otc - When Using
Use only as directed.
Do not bandage tightly or use with a heating pad.
Avoid contact with eyes and mucous membranes.
Do not apply to wounds or damaged, broken, or irritated skin.
A transient burning sensation or redness may occur upon application but generally disappears in several days.
If you experience an allergic reaction, discontinue use, and consult a doctor.
Do not expose the area treated with product to heat or direct sunlight.
Otc - Stop Use
Condition worsens.
Redness is present.
Irritation develops.
Symptoms persist for more than 7 days or clear up occur again within a few days.
You experience signs injury, such as pain, swelling or blistering where the product was applied.
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 of age
Apply a small amount on the affected area.
Massage in 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: do not use, consult a doctor.
Inactive Ingredient
Isopropyl Myristate, Fragrance (Parfum), Limonene, Pimpinella Anisum (Aniseed) Seed Oil, Mentha Piperita (Peppermint) Oil, Citrus Aurantium Dulcis (Orange) Oil, Eucalyptus Oil, Ocimum Basilicum (Basil) Oil.
* Please review the disclaimer below.
