FDA.reportPublic FDA data

Lip Clear Lysine Plus

Manufacturer
Quantum, Inc. | Sun Deep Inc.
Effective date
2025-10-20
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-06-01 01:39:50

Label at a glance#

ProductLip Clear 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. / Véase folleto para más información

Dosage and administration

For adults and children 2 and older. Apply liberally as needed. For best results, apply every two hours. Wash hands before and after applying. / Para adultos y niños mayores de dos años. Aplíquese abundantemente según la necesidad. Para mejores resultados repita la aplicación cada dos horas. Lávese las manos antes y después de cada aplicación.

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 / Tratamiento para las ampollas labiales y los herpes labial

Uses

INDICATIONS & USAGE SECTION

Relieves tingling, itching, burning, blistering and pain associated with cold sores/fever blisters. / Véase folleto para más información

Warnings

WARNINGS SECTION

For external use only

OTC - WHEN USING SECTION

When using this productdo not get into eyes.

Stop use and ask a doctor if

OTC - STOP USE SECTION

  • condition worsens
  • 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 two hours. Wash hands before and after applying. / Para adultos y niños mayores de dos años. Aplíquese abundantemente según la necesidad. Para mejores resultados repita la aplicación cada dos horas. Lávese las manos antes y después de cada aplicación.

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 gm Tube Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Inspired by Nature

LIP CLEAR ®
Lysine+ ®

Cold Sore Treatment

Cuts Healing Time in Half*

WITH HERBS
VITAMINS & OTHER TOPICALS


  • Fast Pain Relief
  • Stops Burning & Itching

With 14 nutrients including
Lysine, Propolis, Olive Oil & Vitamin E

QUANTUM ®HEALTH

Soothes & Moisturizes

Relieves pain, burning and itching

Net Wt. 7gm /.25 oz.

PRINCIPAL DISPLAY PANEL - 7 gm Tube Carton
PRINCIPAL DISPLAY PANEL - 7 gm Tube Carton

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1812685Lysine Plus 0.1 % Topical OintmentPSN4
1812680menthol 0.1 % Topical OintmentPSN4
1812685menthol 0.001 MG/MG Topical Ointment [Lysine Plus]SBD4
1812680menthol 0.001 MG/MG Topical OintmentSCD4
1812685Lysine Plus 0.1 % Topical OintmentSY4
1812680menthol 0.1 % Topical OintmentSY4

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
QR code linkQR Codescan.me/8jnjw3lipclear-01.jpg

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
70084-320-072025-01-30C16284748780-1ba0f9c33-2f55-a910-e053-dadaa90a0b85Lip Clear ® Lysine + ®
70084-320-072025-01-30C16284748780-1ba0f9c33-2f55-a910-e053-dadaa90a0b85Lip Clear ® Lysine + ®
70084-320-072023-02-09C16284748780-1ba0f9c33-2f55-a910-e053-dadaa90a0b85Lip Clear ® Lysine + ®
70084-320-072023-02-09C16284748780-1ba0f9c33-2f55-a910-e053-dadaa90a0b85Lip Clear ® Lysine + ®
70084-320-072021-01-29C16284748780-1ba0f9c33-2f55-a910-e053-dadaa90a0b85Lip Clear ® Lysine + ®
70084-320-072021-01-29C16284748780-1ba0f9c33-2f55-a910-e053-dadaa90a0b85Lip Clear ® Lysine + ®

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70084-320-07Lip Clear Lysine Plus1 in 1 CARTONOINTMENT14
70084-320-07Lip Clear Lysine Plus7 g in 1 TUBEOINTMENT74

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
70084-32070084-320-07

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
CALENDULA OFFICINALIS FLOWERP0M7O4Y7YDIACT
ECHINACEA PURPUREA WHOLEQI7G114Y98IACT
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
MENTHOL, UNSPECIFIED FORML7T10EIP3AACTIB

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
32023-02-06full-release2026-05-31 23:53:48

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
Lip Clear Lysine PlusMENTHOL, UNSPECIFIED FORMQuantum, Inc.21a5b4fb-baed-4766-9820-5c6051c147202025-10-20WarningsExact identifier
ndc (package): 70084-320-07
ndc (product): 70084-320
ndc11 (package): 70084032007
spl id: 419d00d6-7f99-7348-e063-6394a90a38cd
spl set id: 21a5b4fb-baed-4766-9820-5c6051c14720

Reported adverse events (FAERS/openFDA)#

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