Active Ingredients
Menthol 0.10%
4rlf Topical Analgesic
FDA Label NDC 76849-201
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Rinati Skin, Llc for the product 4rlf Topical Analgesic (NDC 76849-201). 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 ingredients, purpose, uses, warnings, ■ keep out of reach of children., directions for use, inactive ingredients, other information, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
TOPICAL ANALGESIC
Uses
For the temporary relief of pain from minor burns, sunburn, minor cuts, scrapes, and insect bites.
Warnings
For external use only. When using this product ■ Avoid contact with eyes. In case of eye contact, flush eyes with water. ■ If condition worsens, or if symptoms persist for more than 7 days or clear up and occur again within a few days, discontinue use of this product and consult a physician.
■ Keep Out Of Reach Of Children.
If swallowed, get medical help.
Directions For Use
■ Adults and children 2 years of age or older:
Apply to the desired area and gently rub into the skin, not more than
3 to 4 times daily. ■ Children under the age of 2: Consult a physician.
Inactive Ingredients
Propylene Glycol, Ocimum Tenuiflorum Callus Culture Lysate, Glycerin, Dimethyl Sulfone, Water, Withania Somnifera Root Extract, Piper Nigrum (Pepper) Fruit Extract, Gluconolactone, Sodium Benzoate, Citric Acid, Xanthan Gum, Citrus Aurantium Dulcis (Orange) Oil, Hydroxyethylcellulose.
Other Information
■ Storage Instructions: Store in a cool, dark place (<100°F). Avoid storage directly in sunlight.
* Please review the disclaimer below.
