Ikonik Tonik Cream
FDA Label NDC 85132-001

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Ikonik Care, Llc for the product Ikonik Tonik (NDC 85132-001). 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 drug facts, active ingredient, purpose, uses, warnings, otc - keep out of reach of children, directions, other information, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Drug Facts

Active Ingredient

Lidocaine HCL 4% w/v

Purpose

External analgesic

Uses

for the temporary relief of pain and itching associated with • minor cuts • minor skin irritations

Warnings

For external use only

Do not use in large quantities, particularly over • raw surfaces • blistered areas • deep puncture wounds • serious burns

When using this product
• avoid contact with the eyes, mouth or mucous membranes
• avoid excessive use or prolonged application. Overuse may lead to increased risk of side effects

Stop use and ask a doctor if
• condition worsens, or if symptoms persist for more than 7 days or clear up and occur again within a few days
• allergic reaction occurs, or if redness, irritation, swelling, pain or other symptoms begin to increase

If pregnant or breast-feeding, ask a health professional before use.

Otc - Keep Out Of Reach Of Children

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions

• use only as directed
• clean and dry the affected area before applying the cream
• adults and children 2 years of age and older: Apply a thin layer to affected area not more than 3 to 4 times daily
• children under 2 years of age: do not use, consult a doctor
• do not rub in
• wash hands thoroughly after application unless you are using the product for your hands
• do not cover the treated area with a bandage or wrap unless instructed by a doctor

Other Information

• this package is child-resistant
• store at room temperature, away from direct sunlight

Inactive Ingredients

Acetyl Hexapeptide-8 Amide, Butylene Glycol, Cetyl Alcohol, Chloroxylenol, Dimethicone/Divinyldimethicone/Silsesquioxane Crosspolymer, Ethylhexylglycerin, Glyceryl Monostearate, 1,2, Hexanediol, Lecithin, PEG-150 Pentaerythrityl Tetrastearate, Pentapeptide-18, Phenoxyethanol, Polysorbate-80, PPG-2 Hydroxyethyl Cocamide, Propylene Glycol, Pullulan, Sclerotium Gum, Sodium Polyacrylate, Water, Xanthan Gum

Questions?

+1 908-765-8789
You may also report serious side effects to this phone number.
Mon - Fri 9:30 AM - 5:30 PM

Packaging

Ikoncream-3 (85132001 3)

Ikoncream-3 (85132001 3)

* Please review the disclaimer below.