FDA.reportPublic FDA data

Super Lysine plus

Manufacturer
Quantum, Inc.
Effective date
2023-02-07
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-05-31 23:54:05

Label at a glance#

ProductSuper Lysine plus
Active ingredientMenthol, Unspecified Form
Label structure10 sections

Indications and uses

Relieves tingling, itching, burning, blistering, and pain associated with cold sores/fever blisters.

Dosage and administration

For adults and children 2 and older. Apply liberally as needed. For best results, apply every 2 hours. Wash hands before and after applying.

Storage and handling

Store at room temperature and avoid excessive heat. Close cover tightly after each use.

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Menthol 0.1%

Purpose

OTC - PURPOSE SECTION

Cold sore / fever blister treatment

Uses

INDICATIONS & USAGE SECTION

Relieves tingling, itching, burning, blistering, and pain associated with cold sores/fever blisters.

Warnings

WARNINGS SECTION

For external use only.

OTC - WHEN USING SECTION

When using this product do not get into eyes.

OTC - STOP USE SECTION

Stop use and ask a doctor if

  • condition worsens; or
  • symptoms last more than 7 days or clear up and occur again

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

Directions

DOSAGE & ADMINISTRATION SECTION

For adults and children 2 and older. Apply liberally as needed. For best results, apply every 2 hours. Wash hands before and after applying.

Other Information

STORAGE AND HANDLING SECTION

  • Store at room temperature and avoid excessive heat.
  • Close cover tightly after each use.

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Beeswax, Calendula Officinalis Extract, Echinacea Purpurea Extract, Gum Benzoin Tincture, Honey, Hydrastis Canadensis (Goldenseal) Leaf, Lysine, Melaleuca Alternifolia Oil, Melaleuca Cajuputi Oil, Olea Europaea (Olive) Fruit Oil, Propolis Extract, Vitamin A (Retinyl Palmitate), Vitamin D3, Vitamin E (Tocopherol), Zinc Oxide.

SPL UNCLASSIFIED SECTION

DISTRIBUTED BY: QUANTUM, INC.
PO BOX 2791, EUGENE, OR 97402

PRINCIPAL DISPLAY PANEL - 7 g Tube Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Quantum®
HEALTH

SuperLysine+ ®

Cold Sore Treatment
CUTS HEALING TIME IN HALF*

SOOTHES & MOISTURIZES
RELIEVES PAIN, BURNING, & ITCHING

LYSINE PLUS PROPOLIS, OLIVE OIL,
VITAMIN E, & 10 OTHER NUTRIENTS

Ointment

NET WT 7g / .25 OZ

PRINCIPAL DISPLAY PANEL - 7 g Tube Carton
PRINCIPAL DISPLAY PANEL - 7 g Tube Carton

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1812685Lysine Plus 0.1 % Topical OintmentPSN3
1812680menthol 0.1 % Topical OintmentPSN3
1812685menthol 0.001 MG/MG Topical Ointment [Lysine Plus]SBD3
1812680menthol 0.001 MG/MG Topical OintmentSCD3
1812685Lysine Plus 0.1 % Topical OintmentSY3
1812680menthol 0.1 % Topical OintmentSY3

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
ebc62596-fc97-4d03-9483-7ba095d25db7Product name120151210
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
60c52429-fcef-eb54-2387-43bc9e4f296bProduct name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
70084-420-072025-01-30C16284748780-1ba0f9c33-24d0-a910-e053-dadaa90a0b85Super Lysine + ®
70084-420-212025-01-30C16284748780-1ba0f9c33-24d0-a910-e053-dadaa90a0b85Super Lysine + ®
70084-420-072023-02-13C16284748780-1ba0f9c33-24d0-a910-e053-dadaa90a0b85Super Lysine + ®
70084-420-212023-02-13C16284748780-1ba0f9c33-24d0-a910-e053-dadaa90a0b85Super Lysine + ®
70084-420-072021-01-29C16284748780-1ba0f9c33-24d0-a910-e053-dadaa90a0b85Super Lysine + ®
70084-420-212021-01-29C16284748780-1ba0f9c33-24d0-a910-e053-dadaa90a0b85Super Lysine + ®

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70084-420-07Super Lysine plus7 g in 1 TUBEOINTMENT73
70084-420-07Super Lysine plus1 in 1 CARTONOINTMENT13
70084-420-21Super Lysine plus1 in 1 CARTONOINTMENT13
70084-420-21Super Lysine plus21 g in 1 TUBEOINTMENT213

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70084-420SUPER LYSINE PLUS (MENTHOL, UNSPECIFIED FORM) OINTMENT [QUANTUM, INC.]3Legacy NDC, 4 package rows20230214_ecf67a8c-5999-4190-8149-1e2291bfca71.zip

Products#

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

DailyMed product names page 1 of 1 · 17 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
70084-42070084-420-21, 70084-420-07

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 16 matching rows.

Name, UNII, Kind table
NameUNIIKind
Menthol, Unspecified FormL7T10EIP3AACTIB
Calendula Officinalis FlowerP0M7O4Y7YDIACT
Echinacea PurpureaQI7G114Y98IACT
BENZOIN RESINGK21SBA74RIACT
HONEYY9H1V576FHIACT
GOLDENSEALZW3Z11D0JVIACT
LYSINE HYDROCHLORIDEJNJ23Q2COMIACT
TEA TREE OILVIF565UC2GIACT
MELALEUCA CAJUPUTI LEAF OIL5O59RMR6DUIACT
OLIVE OIL6UYK2W1W1EIACT
PROPOLIS WAX6Y8XYV2NOFIACT
VITAMIN A PALMITATE1D1K0N0VVCIACT
CHOLECALCIFEROL1C6V77QF41IACT
.ALPHA.-TOCOPHEROLH4N855PNZ1IACT
ZINC OXIDESOI2LOH54ZIACT
Yellow Wax2ZA36H0S2VIACT

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
285c7d8d-a34b-495b-bf08-c073e5a11d44ecf67a8c-5999-4190-8149-1e2291bfca712023-02-07WarningsExact identifier
spl id: 285c7d8d-a34b-495b-bf08-c073e5a11d44
spl set id: ecf67a8c-5999-4190-8149-1e2291bfca71

Reported adverse events (FAERS/openFDA)#

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