FDA.reportPublic FDA data

Zip Topical Anesthetic Gel Mint

Manufacturer
Germiphene Corporation
Effective date
2017-06-13
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 22:51:39

Label at a glance#

ProductZip Topical Anesthetic Gel Mint
Active ingredientBENZOCAINE
Label structure8 sections

Label contents#

Full prescribing information#

Use or purpose:

INDICATIONS & USAGE SECTION

For rapid topical anesthesia

OTC - ACTIVE INGREDIENT SECTION

Medicinal ingredient: Benzocaine 20.0% w/w

OTC - PURPOSE SECTION

Topical Anesthetic Gel

INACTIVE INGREDIENT SECTION

Non-Medicinal Ingredients: Propylene glycol, polyethylene glycol, carbomer, povidone, sodium saccharin, flavouring, and colouring agents. (Mint flavour only: ethyl alcohol, methyl paraben, propyl paraben).

DOSAGE & ADMINISTRATION SECTION

Directions: Apply approximately 0.2 mL of gel to the desired area using a cotton swab. For adults and children 2 years of age or older. For professional use only. Use only on the advice of a physician.

WARNINGS SECTION

Warning: For external use only. Avoid contact with eyes. If this happens, rinse thoroughly with water. Stop use and consult a health-care practitioner if the following symptoms appear: weakness, confusion, headache, dificulty breathing and/or pale, gray or blue coloured skin as these may be signs of methemoglobinemia, a rare disorder, which may appear up to 2 hours after use. Use smallest amount possible to achieve desired result. Do not use if allergic to benzocaine or any other ingredients in the product. Use with caution in children. Do not use if tamper-evident foil seal is broken. Do not store in direct sunlight. Do not swallow.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Caution: Keep out of reach of children.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

30 g30 g

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
238910benzocaine 20 % Oral GelPSN1
238910benzocaine 0.2 MG/MG Oral GelSCD1
238910benzocaine 20 % (180-220 MG per 1 GM) Oral GelSY1

DailyMed Pharmacologic Classes#

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
61508-0201-12020-01-31C16284748780-19d75b9d0-0850-f424-e053-dadaa90a57ceZip Topical Anesthetic Gel Mint

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
61508-0201-1Zip Topical Anesthetic Gel Mint30 g in 1 JARGEL301

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
61508-0201ZIP TOPICAL ANESTHETIC GEL MINT (BENZOCAINE) GEL [GERMIPHENE CORPORATION]1Legacy NDC, 1 package rows20170616_51dccfdb-a9c8-1d4f-e054-00144ff8d46c.zip

Products#

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

DailyMed product names page 1 of 1 · 13 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
61508-020161508-0201-1

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 12 matching rows.

Name, UNII, Kind table
NameUNIIKind
WATER059QF0KO0RIACT
POVIDONEFZ989GH94EIACT
ALCOHOL3K9958V90MIACT
D&C YELLOW NO. 1035SW5USQ3GIACT
FD&C BLUE NO. 1H3R47K3TBDIACT
METHYLPARABENA2I8C7HI9TIACT
BENZOCAINEU3RSY48JW5ACTIB
PROPYLPARABENZ8IX2SC1OHIACT
SACCHARIN SODIUMSB8ZUX40TYIACT
CARBOMER 934Z135WT9208IACT
PROPYLENE GLYCOL6DC9Q167V3IACT
POLYETHYLENE GLYCOL 400B697894SGQIACT

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
51dccfdb-a9c9-1d4f-e054-00144ff8d46c51dccfdb-a9c8-1d4f-e054-00144ff8d46c2017-06-13WarningsExact identifier
spl id: 51dccfdb-a9c9-1d4f-e054-00144ff8d46c
spl set id: 51dccfdb-a9c8-1d4f-e054-00144ff8d46c

Reported adverse events (FAERS/openFDA)#

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