FDA.reportPublic FDA data

Certus Sting Relief Prep Pad 210004 Drug Facts and Label

Manufacturer
Certus Medical, Inc.
Effective date
2011-04-08
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 22:27:53

Label at a glance#

ProductCertus Sting Relief Prep Pad
Active ingredientBENZOCAINE
Label structure10 sections

Label contents#

Full prescribing information#

Drug Facts Box OTC Active Ingredient Section

OTC - ACTIVE INGREDIENT SECTION

Benzocaine 6%

Drug Facts Box OTC Purpose Section

OTC - PURPOSE SECTION

Topical Anesthetic

Drug Facts Box OTC Indications & Usage Section

INDICATIONS & USAGE SECTION

For temporary relief of pain and itching associated with minor burns, scrapes and insect bites

 

Drug Facts Box OTC Warnings Section

WARNINGS SECTION

for external use only
flammable, keep away from fire or flame

Drug Facts Box OTC Do Not Use Section

OTC - DO NOT USE SECTION

in the eyes

if contact occurs, flush eyes with water

Drug Facts Box OTC Keep Out of Reach of Children Section

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

if swallowed get medical help or contact a Poison Control Center right away

Drug Facts Box OTC Dosage & Administration Section

DOSAGE & ADMINISTRATION SECTION

apply to affected area not more than 3 to 4 times daily, for adults and children 2 years of age or older

children under 2 years: consult physician

Drug Facts Box OTC General Precautions Section

GENERAL PRECAUTIONS SECTION

Store at room temperature 150 - 300 C (590 - 860 F)

Drug Facts Box OTC Inactive Ingredient Section

INACTIVE INGREDIENT SECTION

isopropyl alcohol, purified water

Certus Sting Relief Prep Pad 210004 pouch

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

210004.jpg  Certus Sting Relief Prep Pad  pouch  image of pouch labelimage of pouch label

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1043353benzocaine 6 % Medicated PadPSN1
1043353benzocaine 60 MG/ML Medicated PadSCD1
1043353benzocaine 6 % Medicated WipeSY1
1043353benzocaine 6 % Topical SwabSY1

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
75990-7008-32020-01-31C16284748780-19d75b9d0-b53f-f424-e053-dadaa90a57ceCertus Sting Relief Prep Pad 210004 Drug Facts and Label

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
75990-7008-3Certus Sting Relief Prep Pad0.6 mL in 1 POUCHSWAB0.61

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
75990-7008CERTUS STING RELIEF PREP PAD (BENZOCAINE) SWAB [CERTUS MEDICAL, INC.]1Legacy NDC, 1 package rows20110502_bd5a1262-4498-4453-a6f9-d45d08ea7d6b.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
BENZOCAINEACTIVE INGREDIENTU3RSY48JW51
BENZOCAINEACTIVE MOIETYU3RSY48JW51
ISOPROPYL ALCOHOLINACTIVE INGREDIENTND2M4163021
WATERINACTIVE INGREDIENT059QF0KO0R1

Products#

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

DailyMed product names page 1 of 1 · 4 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
75990-700875990-7008-3

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 3 matching rows.

Name, UNII, Kind table
NameUNIIKind
BENZOCAINEU3RSY48JW5ACTIB
WATER059QF0KO0RIACT
ISOPROPYL ALCOHOLND2M416302IACT

Source Document#

Source XML

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 1 · 9 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
ISOPROPYL ALCOHOLISOPROPYL ALCOHOLND2M416302SOLUTION / TOPICAL40 %w/vExact identifier — unii candidate
9 equally ranked IID candidates
ISOPROPYL ALCOHOLISOPROPYL ALCOHOLND2M416302LOTION, AUGMENTED / TOPICAL2070 mgExact identifier — unii candidate
9 equally ranked IID candidates
ISOPROPYL ALCOHOLISOPROPYL ALCOHOLND2M416302TABLET, EXTENDED RELEASE / ORALNAExact identifier — unii candidate
9 equally ranked IID candidates
ISOPROPYL ALCOHOLISOPROPYL ALCOHOLND2M416302OIL / TOPICAL72 mgExact identifier — unii candidate
9 equally ranked IID candidates
ISOPROPYL ALCOHOLISOPROPYL ALCOHOLND2M416302GEL / TOPICAL75 mgExact identifier — unii candidate
9 equally ranked IID candidates
ISOPROPYL ALCOHOLISOPROPYL ALCOHOLND2M416302SPONGE / TOPICAL4 %w/wExact identifier — unii candidate
9 equally ranked IID candidates
ISOPROPYL ALCOHOLISOPROPYL ALCOHOLND2M416302GEL, METERED / TOPICAL525 mgExact identifier — unii candidate
9 equally ranked IID candidates
ISOPROPYL ALCOHOLISOPROPYL ALCOHOLND2M416302OIL / AURICULAR (OTIC)6 mgExact identifier — unii candidate
9 equally ranked IID candidates
ISOPROPYL ALCOHOLISOPROPYL ALCOHOLND2M416302SWAB / TOPICAL43.9 %w/wExact identifier — unii candidate
9 equally ranked IID candidates

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
ecba17ad-283a-422b-9d84-3a19cc9783c9bd5a1262-4498-4453-a6f9-d45d08ea7d6b2011-04-08WarningsExact identifier
spl id: ecba17ad-283a-422b-9d84-3a19cc9783c9
spl set id: bd5a1262-4498-4453-a6f9-d45d08ea7d6b

Reported adverse events (FAERS/openFDA)#

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