FDA.reportPublic FDA data

TATOO CARE

Manufacturer
INDUSTRIAS QUIMICAS INDEPENDENCIA SA
Effective date
2023-06-16
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 23:55:17

Label at a glance#

ProductTATOO CARE
Active ingredientLIDOCAINE
Label structure1 sections

Label contents#

Full prescribing information#

Package label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Seconday PackageSeconday Package

Primary packagingPrimary packaging

Active ingredients

OTC - ACTIVE INGREDIENT SECTION

Lidocaine 5%

Ask your doctor

OTC - ASK DOCTOR SECTION

If any side effect is observed, discontinue use and consult your healthcare practicioner

Do not use

OTC - DO NOT USE SECTION

Do not use if allergic to Lidocaine or other local anesthetics

Keep out of the reach of children

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of the reach of children

Pregnancy or Breast feeding

OTC - PREGNANCY OR BREAST FEEDING SECTION

Do not use if you are pregnant or breast feeding

Purpose

OTC - PURPOSE SECTION

Topical anesthethics

Questions or comments

OTC - QUESTIONS SECTION

Call us 1-954-607-7658

Warnings

OTC - STOP USE SECTION

If any side effect is observed, discontinued use and consult your healthcare practicioner

Directions

OTC - WHEN USING SECTION

Wash the specific area with soap and warm water to open pores and dry. Apply a thick and even layer of the product

Dosage and administration

DOSAGE & ADMINISTRATION SECTION

Apply a thick and even layer on the area

Warnings

WARNINGS SECTION

For external use only.

  • Before using this product perform an allergy test by applying a small amount of product on the forearm. If no side effect appear after 30 minutes, such asredness, irritation or itching, you can start applying it.
  • Keep out of the reaching of children
  • The use of this product has not been tested in areas such as eyes contours and mucus membranes.
  • Do not use if allergic to lidocaine or other local anesthetics
  • For all kind of skin
  • If any side effect is observed, discontinue use and consult your healthcare practicioner

Inactive ingredients

INACTIVE INGREDIENT SECTION

WATER, CAPRYLIC/CAPRIC/STEARIC TRIGLYCERIDE, GLYCERIN, C13-14 ISOPARAFFIN/LAURETH-7/POLYACRYLAMIDE, CYCLOMETHICONE, JOJOBA OIL, GLYCERYL STEARATE /PEG-100 STEARATE, CETYL ALCOHOL, GLYCERYL STEARATE SE, PHENOXYETHANOL & ETHYLHEXYLGLYCERIN, ALPHA TOCOPHEROL ACETATE, DL ALOE VERA LEAF EXTRACT, CALENDULA OFFICINALIS FLOWER EXTRACT, DIMETHICONE 350, EDETATE DISODIUM, SODIUM HYDROXIDE

Indications

INDICATIONS & USAGE SECTION

Temporary pain relief

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1534792lidocaine 5 % Topical CreamPSN2
1534792lidocaine 50 MG/ML Topical CreamSCD2
1534792lidocaine 5 % Topical CreamSY2

DailyMed Pharmacologic Classes#

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
83527-1001-12025-01-30C16284748780-11030e365-2332-111a-e063-dadaa90a10e2fdb74c89-255d-ab2b-e053-6294a90a098b
83527-1001-12024-01-30C16284748780-11030e365-2332-111a-e063-dadaa90a10e2fdb74c89-255d-ab2b-e053-6294a90a098b

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
83527-1001-1TATOO CARE30 g in 1 TUBECREAM302
83527-1001-1TATOO CARE1 in 1 BOXCREAM12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
83527-1001TATOO CARE (LIDOCAINE) CREAM [INDUSTRIAS QUIMICAS INDEPENDENCIA SA]22 package rows20230619_fdb74c89-255d-ab2b-e053-6294a90a098b.zip

Products#

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

DailyMed product names page 1 of 1 · 21 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
83527-100183527-1001-1

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 20 matching rows.

Name, UNII, Kind table
NameUNIIKind
LIDOCAINE98PI200987ACTIB
WATER059QF0KO0RIACT
LAURETH-7Z95S6G8201IACT
POLYACRYLAMIDE (10000 MW)E2KR9C9V2IIACT
CYCLOMETHICONENMQ347994ZIACT
JOJOBA OIL724GKU717MIACT
GLYCERYL STEARATE SEFCZ5MH785IIACT
EDETATE DISODIUM7FLD91C86KIACT
ETHYLHEXYLGLYCERIN147D247K3PIACT
.ALPHA.-TOCOPHEROL ACETATE, DL-WR1WPI7EW8IACT
ALOE VERA LEAFZY81Z83H0XIACT
CALENDULA OFFICINALIS FLOWERP0M7O4Y7YDIACT
SODIUM HYDROXIDE55X04QC32IIACT
CETYL ALCOHOL936JST6JCNIACT
PHENOXYETHANOLHIE492ZZ3TIACT
DIMETHICONE 3502Y53S6ATLUIACT
C13-14 ISOPARAFFINE4F12ROE70IACT
CAPRYLIC/CAPRIC/PALMITIC/STEARIC TRIGLYCERIDEZF29F7IK5IIACT
GLYCERINPDC6A3C0OXIACT
GLYCERYL STEARATE/PEG-100 STEARATERD25J5V947IACT

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
fe43061a-be2e-e873-e053-6294a90adbe3fdb74c89-255d-ab2b-e053-6294a90a098b2023-06-16WarningsExact identifier
spl id: fe43061a-be2e-e873-e053-6294a90adbe3
spl set id: fdb74c89-255d-ab2b-e053-6294a90a098b

Reported adverse events (FAERS/openFDA)#

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