PENICHILLIN

Manufacturer
Sambria Pharmaceuticals, LLC
Effective date
2023-08-17
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:55:55

Label at a glance#

ProductPENICHILLIN
Active ingredientLIDOCAINE
Label structure9 sections

Indications and uses

For temporary relief of pain and itching due to minor skin irritation.

Dosage and administration

For adults and children two-years or older:Apply to affected area not more than 3 or 4 times daily. Children under 2 years of age: consult a physician. Apply in a circular motion for 30 to 60 seconds.

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Lidocaine 4%

Purpose

OTC - PURPOSE SECTION

External Analgesic

Uses

INDICATIONS & USAGE SECTION

For temporary relief of pain and itching due to minor skin irritation.

Warnings

WARNINGS SECTION

For external use only. Avoid contact with eyes. Do not use in large quantities, particularly over raw surfaces or blistered areas.

Stop use and ask doctor if condition worsens or if symptoms persist for more than 7 days or clear up and occur again within a few days.

Keep out of reach of children. If product is swallowed, get medical help or contact a poison control center immediately.

Keep out of reach of children

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If swallowed, get medical help or contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

For adults and children two-years or older:Apply to affected area not more than 3 or 4 times daily.

Children under 2 years of age: consult a physician. Apply in a circular motion for 30 to 60 seconds.

Inactive ingredients

INACTIVE INGREDIENT SECTION

Aqua (Deionized Water), Arnica Montana Flower Extract, C13-14 Isoparaffin, Chrondroitin Sulfate, Emu Oil, Ethoxydiglycol, Ethylhexyglycerin,
Glucosamine Sulfate, Isopropyl Palmitate, Laureth-7, Melaleuca Alternifolia (Tea Tree) Oil, Methylsulfonylmethane (MSM), Phenoxyethanol,
Polyacrylamide, Propylene Glycol,StearicAcid,Triethanolamine.

Other information

SPL UNCLASSIFIED SECTION

Protect this product from excessive heat and direct sun. Never tested on animals, just late clients.

Product label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

image descriptionimage description

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1421893lidocaine 4 % Topical CreamPSN1
1421893lidocaine 40 MG/ML Topical CreamSCD1
1421893lidocaine 4 % Topical CreamSY1

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
54723-013-012025-01-30C16284748780-12cef2736-b3a7-d83d-e063-dadaa90ab31fad8c8d98-d9fc-47f0-8cee-0793fec5e66b

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
54723-013-01PENICHILLIN4 mL in 1 PACKETCREAM41

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
54723-013PENICHILLIN (LIDOCAINE) CREAM [SAMBRIA PHARMACEUTICALS, LLC]11 package rows20230818_ad8c8d98-d9fc-47f0-8cee-0793fec5e66b.zip

Products#

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

DailyMed product names page 1 of 1 · 19 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
54723-01354723-013-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 18 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
0323fd1e-d879-6ac0-e063-6294a90a39d4ad8c8d98-d9fc-47f0-8cee-0793fec5e66b2023-08-17WarningsExact identifier
spl id: 0323fd1e-d879-6ac0-e063-6294a90a39d4
spl set id: ad8c8d98-d9fc-47f0-8cee-0793fec5e66b

Reported adverse events (FAERS/openFDA)#

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