The following Structured Product Label (SPL) was submitted to the FDA by Buzzie Llc for the product Anti-itch Cream (NDC 84051-001). 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, dosage & administration, other safety information, inactive ingredient, otc - questions, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
All active ingredients are HPUS
Althaea Officinalis 1X, Arnica Montana 1X, Hypericum Perforatum 1X, Lycopodium Clavatum 1X, Mezereum 4X, Sabina 3X, Urtica Urens 1X
Purpose: Anti-inflammatory, Anti-itching & burning, Analgesic, Relieves itching, burning, stinging
*HPUS indicates the active ingredients are in the official Homeopathic Pharmacopoeia of the United States.
Active Ingredients (Active Converted)
Purpose
Anti-inflammatory, Anti-itching & burning, Analgesic
Relieves itching, burning, stinging
Purpose Section (Buzzie Purpose Section)
Uses For the temporary relief of inflammation, pain, itching, burning and stinging sensation. Indications are based on Homeopathic Materia Medica, not clinical testing.
Product efficacy and claims are based on theories of homeopathy that are not supported by scientific evidence and most allopathic medical professionals.
Uses Section (Buzzie Uses Section)
Warning
For external use only
Do not use on damaged or broken skin
Keep out of • eyes • open wounds • mucous membranes
Stop use and ask a physician if • condition worsens or persist • rash develops
Ask a physician before use if you are taking a prescription drug or have a serious medical condition
If pregnant or breastfeeding consult your doctor before use
Keep out of the reach of children If swallowed, get medical help or contact a Poison Control Center right away
Warning Section (Buzzie Warnings Section)
Directions: Adults and children 2 years of age and older, apply a thin layer of cream on clean skin to cover the affected area • For best results, allow cream to be absorbed into the skin: do not rub in • Apply at the onset of symptoms, not more than 6 times daily or every 15 minutes for the first hour • Do not use with other topical remedies or lotions.
Directions (Buzzie Dosage Directions Section)
Other Information
Store in a cool dark place away from children
• Avoid direct sunlight
• Tamper-evident seal for your protection. Use only if safety seal is intact
Other Information (Buzzie Other Information Section)
Inactive Ingredients
Adansonia Digitata (Baobab) Seed Oil, Aqua/Water, Butylene Glycol & Chenopodium Quinoa Seed, Citric Acid, Cross-linked acrylic acid homopolymer, Ethyl Alcohol, Mentha Piperita Oil, Methyl Glucose Dioleate, Sodium Hydroxide
Inactive Ingredients (Buzzie Inactive Ingredients Section)
Questions or Comments? Visit us at Buzzie.com
Question Section (Buzzie Questions Section)
Keep out of reach of children.
If swallowed, get medical help or contact a Poison Control Center right away.
Warning Section (Buzzie Warnings Section)
FAMILY FRIENDLY*
Buzzie
ANTI-ITCH CREAM
PLANT-POWERED INGREDIENTS
The best places in the world are full of bugs
NET WT 0.53 OZ (15GM)
*when used as directed
Front Panel (Buzzie Principal Display Panel)
* Please review the disclaimer below.
