Otc - Active Ingredient
Menthol …………………………………………...………………….……... 2%
Natural 17 Herbal Splash
FDA Label NDC 80770-020
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Natural 17 for the product Natural 17 Herbal Splash (NDC 80770-020). 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, extremely flammable, otc - when using, stop use and ask a doctor if, otc - pregnancy or breast feeding, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Purpose
Topical Analgesic
Indications & Usage
For temporary relief of minor pains on muscles and joints.
Warnings
For external use only.
Do not use on wounds or damaged skin, with a heating pad or on a child under 12 years of age.
Extremely Flammable
Keep away from fire or flame.
Otc - When Using
Use only as directed.
Avoid contact with eyes and mucous membranes.
If you experience an allergic reaction, discontinue use, and consult a physician.
Do not expose the area treated with product to heat or direct sunlight.
Stop Use And Ask A Doctor If
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
Spray two to three pumps or as necessary to cover the affected area not more than three to four times daily.
Children under 12 years of age: do not use, consult a doctor.
Other Information
Store tightly closed in a dry place at controlled room temperature between 59°-86° F (15°-30° C).
Inactive Ingredient
Alcohol Denat, Water (Aqua), Eucalyptus Globulus Leaf Oil, Isopropyl Alcohol, Propylene Glycol, Fragrance (Parfum), Polysorbate 20, Mentha Arvensis Herb Oil, Thymus Vulgaris (Thyme) Oil, Aloe Barbadensis Leaf Extract, Glycerin, Benzyl Alcohol, Benzoic Acid, Sorbic Acid, Geraniol, Hexyl Cinnamal, Amyl Cinnamal, Citronellol, Hydroxycitronnellal, Linalool, Coumarin.
* Please review the disclaimer below.
