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| Product NDC Code | 85132-001 | ||||
|---|---|---|---|---|---|
| Drug Name | Ikonik tonik |
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| Type | Brand | ||||
| Pharm Class | Amide Local Anesthetic [EPC], Amides [CS], Antiarrhythmic [EPC], Local Anesthesia [PE] |
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| Active Ingredients |
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| Route | TOPICAL | ||||
| Dosage Form | CREAM | ||||
| Application Number | M017 | ||||
| Labeler Name | IKONIK CARE, LLC | ||||
| Packages |
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Active ingredient
A list of the active, medicinal ingredients in the drug product.Active ingredient Lidocaine HCL 4% w/v
Dosage and administration
Information about the drug product’s dosage and administration recommendations, including starting dose, dose range, titration regimens, and any other clinically sigificant information that affects dosing recommendations.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
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.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
Indications and usage
A statement of each of the drug products indications for use, such as for the treatment, prevention, mitigation, cure, or diagnosis of a disease or condition, or of a manifestation of a recognized disease or condition, or for the relief of symptoms associated with a recognized disease or condition. This field may also describe any relevant limitations of use.Uses for the temporary relief of pain and itching associated with • minor cuts • minor skin irritations
Purpose
Information about the drug product’s indications for use.Purpose External analgesic
Spl product data elements
Usually a list of ingredients in a drug product.IKONIK TONIK Lidocaine Hydrochloride LIDOCAINE HYDROCHLORIDE LIDOCAINE LIDOCAINE HYDROCHLORIDE ANHYDROUS ACETYL HEXAPEPTIDE-8 AMIDE BUTYLENE GLYCOL CETYL ALCOHOL CHLOROXYLENOL DIMETHICONE/DIVINYLDIMETHICONE/SILSESQUIOXANE CROSSPOLYMER ETHYLHEXYLGLYCERIN GLYCERYL MONOSTEARATE 1,2-HEXANEDIOL SOYBEAN LECITHIN PEG-150 PENTAERYTHRITYL TETRASTEARATE PENTAPEPTIDE-18 PHENOXYETHANOL POLYSORBATE 80 PPG-2 HYDROXYETHYL COCAMIDE PROPYLENE GLYCOL PULLULAN BETASIZOFIRAN SODIUM POLYACRYLATE (8000 MW) WATER XANTHAN GUM
Package label principal display panel
The content of the principal display panel of the product package, usually including the product’s name, dosage forms, and other key information about the drug product.Packaging IKONCream-3
Spl unclassified section
Information not classified as belonging to one of the other fields. Approximately 40% of labeling with effective_time between June 2009 and August 2014 have information in this field.Drug Facts
FOR TEMPORARY RELIEF FROM PAIN IKONIK 4% Lidocaine HCL External Analgesic Cream temporary relief for minor skin irritations. Formulated with lidocaine hcl, a trusted local anesthetic, it works by temporarily blocking nerve signals, providing effective relief from pain, itching, and discomfort. Ideal for treating minor burns, cuts, insect bites, and other minor skin irritations, IKONIK helps soothe and calm the skin. Its easy-to-apply cream formula ensures targeted relief exactly where it's needed. Whether for pain and itching associated with minor cuts, or daily skin discomforts, IKONIK 4% Lidocaine HCl delivers localized temporary relief for sensitive areas. THIS UNIT NOT LABELED FOR INDIVIDUAL RETAIL SALE Distributed by IKONIK Care LLC 954 Lexington Ave, PMB 3011, New York, NY 10021 Made in UK ikonikcare.com CRUELTY FREE
Keep out of reach of children
Information pertaining to whether the product should be kept out of the reach of children, and instructions about what to do in the case of accidental contact or ingestion, if appropriate.Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.
Questions
A telephone number of a source to answer questions about a drug product. Sometimes available days and times are also noted.Questions? +1 908-765-8789 You may also report serious side effects to this phone number. Mon - Fri 9:30 AM - 5:30 PM
Storage and handling
Information about safe storage and handling of the drug product.Other information • this package is child-resistant • store at room temperature, away from direct sunlight
Warnings
Information about serious adverse reactions and potential safety hazards, including limitations in use imposed by those hazards and steps that should be taken if they occur.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. Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.
Disclaimer: Do not rely on openFDA or Phanrmacy Near Me to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Source: OpenFDA, Healthporta Drugs API