Ikonik™ Tonik®

Ikonik™ Tonik®
SPL v1
SPL
SPL Set ID 122fdfe8-b5fa-46d1-9fd9-3df9887ed320
Route
TOPICAL
Published
Effective Date 2025-01-16
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Inactive Ingredients
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

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2024-12-01

Description

Lidocaine HCL 4% w/v

Purpose

External analgesic


Medication Information

Purpose

External analgesic

Description

Lidocaine HCL 4% w/v

Uses

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

Section 42229-5

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

Section 50565-1

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

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.

Packaging

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

Drug Facts

Questions?

+1 908-765-8789

You may also report serious side effects to this phone number.

Mon - Fri 9:30 AM - 5:30 PM

Active Ingredient

Lidocaine HCL 4% w/v

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


Structured Label Content

Uses

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

Section 42229-5 (42229-5)

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

Section 50565-1 (50565-1)

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

Purpose

External analgesic

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.

Packaging

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

Drug Facts

Questions?

+1 908-765-8789

You may also report serious side effects to this phone number.

Mon - Fri 9:30 AM - 5:30 PM

Active Ingredient (Active ingredient)

Lidocaine HCL 4% w/v

Other Information (Other information)

• this package is child-resistant

• store at room temperature, away from direct sunlight

Inactive Ingredients (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


Advanced Ingredient Data


Raw Label Data

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