FDA Label for Ikonik Tonik

View Indications, Usage & Precautions

Ikonik Tonik Product Label

The following document was submitted to the FDA by the labeler of this product Ikonik Care, Llc. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

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




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