IKONIK™ TONIK ® CREAM LIDOCAINE HCL EXTERNAL ANALGESIC CREAM

Manufacturer
IKONIK CARE, LLC
Effective date
2025-01-14
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 00:53:32

Label at a glance#

ProductIKONIK TONIK
Active ingredientLIDOCAINE HYDROCHLORIDE
Label structure10 sections

Indications and uses

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

Dosage and administration

• 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...

Storage and handling

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

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Lidocaine HCL 4% w/v

Purpose

OTC - PURPOSE SECTION

External analgesic

Uses

INDICATIONS & USAGE SECTION

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

Warnings

WARNINGS SECTION

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 SECTION

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

Directions

DOSAGE & ADMINISTRATION SECTION

• 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

STORAGE AND HANDLING SECTION

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

Inactive ingredients

INACTIVE INGREDIENT SECTION

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?

OTC - QUESTIONS SECTION

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

SPL UNCLASSIFIED SECTION

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

Packaging

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

IKONCream-3IKONCream-3

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1010895lidocaine HCl 4 % Topical CreamPSN1
1010895lidocaine hydrochloride 40 MG/ML Topical CreamSCD1
1010895lidocaine hydrochloride 4 % Topical CreamSY1

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
LIDOCAINE Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
070fbed5-7088-434a-a7ce-f2a64d8d40acProduct name220260107
bee66ce1-adb7-9d3b-67d9-582e4c54e80fProduct name520250819
860a93dc-4863-49cc-b284-6bbe8191bc48Product name420250214
eaba870a-6a9d-442e-8643-87b3f558a451Product name120250117
9b4cf230-fd05-41d5-98c6-5db9ecb27b86Product name120230117
7d755fa1-1087-4dcd-98f0-6d4bba479a57Product name320210602
aed701d5-9c75-dfaf-7154-cde46179faeaProduct name920200313
fa8b5901-e681-426f-82fe-54f6d81ec698Product name420180619
332d03e4-aa24-4b11-841a-02bf41081920Product name120171221
c08ab52f-2fc8-4409-9d9f-ed8edc0bd070Product name120171221
68ed98f8-24c2-44a0-944a-6d36e82ce25aProduct name120141222
1cd42bc2-a430-c72b-636d-991b235fbf80Product name120140508
49fa150c-f0de-cce7-3d9c-993ed81c5698Product name120140508
4d7ae718-ed00-bae8-2abe-9eaec1eef7ffProduct name120140508
9137811f-f279-8640-5aeb-99fa2145d64dProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
85132-001-30IKONIK TONIK1 in 1 BOXCREAM11
85132-001-30IKONIK TONIK30 mL in 1 TUBECREAM301

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
85132-001IKONIK TONIK (LIDOCAINE HYDROCHLORIDE) CREAM [IKONIK CARE, LLC]1Current NDC, 2 package rows20250125_122fdfe8-b5fa-46d1-9fd9-3df9887ed320.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 24 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
85132-00185132-001-30

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 21 matching rows.

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
IKONIK TONIKLIDOCAINE HYDROCHLORIDEIKONIK CARE, LLC122fdfe8-b5fa-46d1-9fd9-3df9887ed3202025-01-14WarningsExact identifier
ndc (package): 85132-001-30
ndc (product): 85132-001
ndc11 (package): 85132000130
spl id: a30cc8cf-1348-46ef-b903-b24ca134228a
spl set id: 122fdfe8-b5fa-46d1-9fd9-3df9887ed320

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.