FDA.reportPublic FDA data

SALINOCAINE OINTMENT

Manufacturer
Medical Products Laboratories, Inc.
Effective date
2024-08-07
Label type
HUMAN PRESCRIPTION DRUG LABEL
Version
9
Source
full-release
Hydrated at
2026-05-31 21:09:52

Label at a glance#

ProductSalinocaine
Active ingredientSALICYLIC ACID, BENZOCAINE
Label structure2 sections

Dosage and administration

Each Gram Contains: 550mg of Salicylic acid and 20mg of Benzocaine. Also Contains: Petrolatum, Glycerin, Benzalkonium Chloride 0.1% added as a preservative. Premier ® Medical Products 1710 Romano Drive Plymouth Meeting, PA 19462 USA (610) 239-6053 www.premusa.com   Technology by Medical Products Laboratories, Inc. Philadelphia, PA 19115-1083, U.S.A. For external use only. Caution: Federal (U.S.A.) law prohibits di...

Label contents#

Full prescribing information#

DIRECTIONSIsolate verruca with adhesive tape. Remove weight bearing pressure by using felt pad with aperture. Apply Salinocaine to verruca and dress with waterproof tape to guard against water dilution. Repeat treatment every 10 days if needed.

DESCRIPTION SECTION

Each Gram Contains: 550mg of Salicylic acid and 20mg of Benzocaine. Also Contains: Petrolatum, Glycerin, Benzalkonium Chloride 0.1% added as a preservative.

Premier ® Medical Products 1710 Romano Drive Plymouth Meeting, PA 19462 USA (610) 239-6053 www.premusa.com 

Technology by Medical Products Laboratories, Inc. Philadelphia, PA 19115-1083, U.S.A.

For external use only.
Caution: Federal (U.S.A.) law prohibits dispensing without prescription.
Made in U.S.A.

To obtain a MSDS Sheet, visit www.premusa.com or call Premier Customer Service at (610) 239-6053.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

SalinocaineSalinocaine

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1603377salicylic acid 550 MG / benzocaine 20 MG per GM Topical OintmentPSN9
1603382Salinocaine (salicylic acid 550 MG / benzocaine 20 MG) per GM Topical OintmentPSN9
1603382benzocaine 0.02 MG/MG / salicylic acid 0.55 MG/MG Topical Ointment [Salinocaine]SBD9
1603377benzocaine 0.02 MG/MG / salicylic acid 0.55 MG/MG Topical OintmentSCD9
1603377benzocaine 2 % / salicylic acid 55 % Topical OintmentSY9
1603382Salinocaine (benzocaine 2 % / salicylic acid 55 % ) Topical OintmentSY9

DailyMed Pharmacologic Classes#

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

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
dea2eded-d1e7-46bb-9a3d-f8dc20de6277Product name120190408

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
10733-415-402020-11-25C16284748780-19d75b9d0-032e-f424-e053-dadaa90a57ceSALINOCAINE OINTMENT
10733-415-402020-01-31C16284748780-19d75b9d0-032e-f424-e053-dadaa90a57ceSALINOCAINE OINTMENT

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
10733-415-40Salinocaine40 g in 1 JAROINTMENT409

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
10733-415SALINOCAINE (SALICYLIC ACID AND BENZOCAINE) OINTMENT [MEDICAL PRODUCTS LABORATORIES, INC.]9Current NDC, Legacy NDC, 1 package rows20240809_49d9f83d-3055-f80e-e58a-b6fca192ac8d.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
BenzocaineACTIVE INGREDIENTU3RSY48JW54
Salicylic AcidACTIVE INGREDIENTO414PZ4LPZ4
BenzocaineACTIVE MOIETYU3RSY48JW54
Salicylic AcidACTIVE MOIETYO414PZ4LPZ4
Benzalkonium ChlorideINACTIVE INGREDIENTF5UM2KM3W74
GlycerinINACTIVE INGREDIENTPDC6A3C0OX4
PetrolatumINACTIVE INGREDIENT4T6H12BN9U4

Products#

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

DailyMed product names page 1 of 1 · 7 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
10733-41510733-415-40

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 5 matching rows.

Name, UNII, Kind table
NameUNIIKind
PETROLATUM4T6H12BN9UIACT
GLYCERINPDC6A3C0OXIACT
BENZALKONIUM CHLORIDEF5UM2KM3W7IACT
SALICYLIC ACIDO414PZ4LPZACTIB
BENZOCAINEU3RSY48JW5ACTIB

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 · 6 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
GlycerinGLYCERINPDC6A3C0OXOINTMENT / TOPICALNAExact identifier — unii+route+dosage form
2 equally ranked IID candidates
Benzalkonium ChlorideBENZALKONIUM CHLORIDEF5UM2KM3W7OINTMENT / TOPICAL0.03 %w/wExact identifier — unii+route+dosage form
2 equally ranked IID candidates
Benzalkonium ChlorideBENZALKONIUM CHLORIDEF5UM2KM3W7OINTMENT / TOPICAL0.03 %w/wExact identifier — unii+route+dosage form
2 equally ranked IID candidates
PetrolatumPETROLATUM4T6H12BN9UOINTMENT / TOPICAL7275 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
GlycerinGLYCERINPDC6A3C0OXOINTMENT / TOPICALNAExact identifier — unii+route+dosage form
2 equally ranked IID candidates
PetrolatumPETROLATUM4T6H12BN9UOINTMENT / TOPICAL7275 mgExact identifier — unii+route+dosage form
2 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
SalinocaineSALICYLIC ACID AND BENZOCAINEMedical Products Laboratories, Inc.49d9f83d-3055-f80e-e58a-b6fca192ac8d2024-08-07Exact identifier
ndc (package): 10733-415-40
ndc (product): 10733-415
ndc11 (package): 10733041540
spl id: 1f19cc2c-57ab-4ad4-e063-6294a90a7613
spl set id: 49d9f83d-3055-f80e-e58a-b6fca192ac8d

Reported adverse events (FAERS/openFDA)#

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