Active Ingredients
Lidocaine Hydrochloride 4%
Menthol 1%
Botanika Life
FDA Label NDC 58443-0391
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Prime Enterprises, Inc. for the product Botanika Life (NDC 58443-0391). 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, do not use, when using this product, stop use and ask a doctor, 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
Purpose
Topical Analgesic
Uses
For the temporary relief of pain and itching associated with minor burns, sunburn, minor cuts, scrapes, insect bites or minor skin irritations.
Warnings
For external use only
Do Not Use
in large quantities, particularly over raw surfaces or blistered areas.
When Using This Product
avoid contact with the eyes.
Use only as directed.
Stop Use And Ask A Doctor
if condition worsens, or if symptoms persist more than 7 days or clear up and occur again within a few days.
Keep Out Of Reach Of Children.
If product is swallowed, get medical help or contact a Poison Control Center right away.
If Pregnant Or Breast-Feeding,
ask a health professional before use.
Directions
Adults and children 2 years of age and older:
Apply to affected area not more than 3 to 4 times daily
Children under 2 years of age: Consult a doctor.
Inactive Ingredients
Aloe Barbadensis Leaf Juice, Arnica Montana Flower Extract, Boswellia Serrata Extract, Cannabidiol, Dimethyl Sulfone, Glycerin, Polyacrylate-13, Polyisobutene, Polysorbate 20, SD Alcohol 40-B, Tocopheryl Acetate, Water
Botanika Life Super Soothing Pain Serum
Principal Display Panel (58443 0391 3)
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