PANTIN

Manufacturer
tmt america llc
Effective date
2021-10-06
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-05-31 23:42:38

Label at a glance#

ProductPANTIN
Active ingredientLIDOCAINE
Label structure9 sections

Dosage and administration

Directions For Adult & Children above 12 years of Age : · Applied Before the procedure · Apply very thick to area and around - Once rubbed in · apply another layer of cream to the area - Cover the area with saran-Wrap in order for it to remain thick. For Children under 12 years of age: Consult a physician.

Label contents#

Full prescribing information#

ACTIVE INGREDIENTS:

OTC - ACTIVE INGREDIENT SECTION

Lidocaine BP 5%w/w

PURPOSE:

OTC - PURPOSE SECTION

Topical Anaesthetic

INDICATIONS & USAGE

INDICATIONS & USAGE SECTION

Uses for temporary relief of pain and itching due to minor skin irritation . To provide topical local analgesia for superficial

dermatological procedures.

WARNING:

WARNINGS SECTION

- For External Use only.

When using this Product - Avoid contact with eyes - Do not use ​in large quantities, particularly over raw surfaces or blistered areas .

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. Discontinue use.

KEEP OUT OF REACH OF CHILDREN

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

DIRECTIONS FOR USE:

DOSAGE & ADMINISTRATION SECTION

Directions For Adult & Children above 12 years of Age :

· Applied Before the procedure

· Apply very thick to area and around - Once rubbed in

· apply another layer of cream to the area - Cover the area with saran-Wrap in order for it to remain thick.

For Children under 12 years of age: Consult a physician.

INACTIVE INGREDIENTS:

INACTIVE INGREDIENT SECTION

Cetostearyl Alcohol , Ceto Macrogol 1000 , Micro Wax, Paraffin Wax, Light Liquid Paraffin, Propylene Glycol, Glycerin & Methyl Paraben

OTHER INFROMATIONS:

OTHER SAFETY INFORMATION

Protect this product from excessive heat and direct Sun - Please test on small area before use.

* These statements are not evaluated by Food & Drug Administration.

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

MAX STREGTH FAST ACTING PANTIN Topical Aneasthetic cream Tattooing- body piercing-Laser treatment-Body waxing www.pantincream.com 50gMAX STREGTH FAST ACTING PANTIN Topical Aneasthetic cream Tattooing- body piercing-Laser treatment-Body waxing www.pantincream.com 50gNDC 81959-0001-3 MAX STREGTH FAST ACTING PANTIN Lidocaine 5% Topical Aneasthetic cream Tattooing- body piercing-Laser treatment-Body waxing 30gNDC 81959-0001-3 MAX STREGTH FAST ACTING PANTIN Lidocaine 5% Topical Aneasthetic cream Tattooing- body piercing-Laser treatment-Body waxing 30gNDC 81959-0001-3 MAX STREGTH FAST ACTING PANTIN Lidocaine 5% Topical Aneasthetic cream Tattooing- body piercing-Laser treatment-Body waxing 30gNDC 81959-0001-3 MAX STREGTH FAST ACTING PANTIN Lidocaine 5% Topical Aneasthetic cream Tattooing- body piercing-Laser treatment-Body waxing 30gNDC 81959-0001-1 MAX STREGTH FAST ACTING PANTIN Topical Aneasthetic cream Tattooing- body piercing-Laser treatment-Body waxing www.pantincream.com100gNDC 81959-0001-1 MAX STREGTH FAST ACTING PANTIN Topical Aneasthetic cream Tattooing- body piercing-Laser treatment-Body waxing www.pantincream.com100g

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1534792lidocaine 5 % Topical CreamPSN4
1534792lidocaine 50 MG/ML Topical CreamSCD4
1534792lidocaine 5 % Topical CreamSY4

DailyMed Pharmacologic Classes#

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

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
81959-0001-1PANTIN100 g in 1 JARCREAM1004
81959-0001-1PANTIN1 in 1 CARTONCREAM14
81959-0001-3PANTIN1 in 1 CARTONCREAM14
81959-0001-3PANTIN30 g in 1 TUBE, WITH APPLICATORCREAM304
81959-0001-5PANTIN1 in 1 CARTONCREAM14
81959-0001-5PANTIN50 g in 1 JARCREAM504

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
81959-0001PANTIN (LIDOCAIN CREAM 5%) CREAM [TMT AMERICA LLC]4Legacy NDC, 6 package rows20211007_cdae75e3-4d35-7a62-e053-2995a90a7842.zip

Products#

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

DailyMed product names page 1 of 1 · 12 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
81959-000181959-0001-5, 81959-0001-1, 81959-0001-3

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 10 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
cdabe6d8-5cb0-1fc7-e053-2a95a90a32e1cdae75e3-4d35-7a62-e053-2995a90a78422021-10-06WarningsExact identifier
spl id: cdabe6d8-5cb0-1fc7-e053-2a95a90a32e1
spl set id: cdae75e3-4d35-7a62-e053-2995a90a7842

Reported adverse events (FAERS/openFDA)#

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