Labisan

Manufacturer
Labisan Americas, LLC. | Lupuca Pharma GmbH.
Effective date
2020-06-06
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-05-31 23:16:28

Label at a glance#

ProductLabisan
Active ingredientPHENOL, ZINC OXIDE
Label structure9 sections

Indications and uses

Uses for treatment of cold sores/fever blisters on the lips, face, and/or nose temporarily relieves the symptoms of itching and pain associated with cold sores/fever blisters prevents outbreak of cold sore/fever blister if applied at first indication of an out break (tingle, or burning sensation) heals cold sore/fever blisters prevents and heals sun burn to lips and stimulates rapid healing

Dosage and administration

• Directions clean the affected area at first sign of tingling, burning sensation, or itching. apply a small amount of this products to the lips and nose prior to exposure to the sun. in case of cold sore/fever blister indication, apply to area of sensation. apply up to 4 times a day, and in the evening. rub in gently. wash hands before and after applying cream. do not share product with anyone. children under 12 ...

Label contents#

Full prescribing information#

Active ingredients

OTC - ACTIVE INGREDIENT SECTION

_________________________________________________________________

Active Ingredients Purpose

Zinc Oxide 20.00%................................................................Cold sore/fever blister treatment/first aid/ sun protectant

Phenol 4.00%........................................................................Cold sore/fever blister treatment/first aid antiseptic

Sulfur Praecipitotum 10.00%.................................................Cold sore/fever blister treatment/first aid antiseptic

___________________________________________________________________________________________

Inactive Ingredients

INACTIVE INGREDIENT SECTION

nactive ingredients Talcum, vaseline, shea butter, paraffin, Olive oil, castor oil, iron oxide yellow and red (for color).

___________________________

Keep out of reach Children

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 at 1-800-222-1222.

______________

WARNINGS SECTION

Warnings

For external use only: Do not use in the eyes, or apply over large areas of the body.

In case of deep or puncture wounds, animal bites, or serious burns, consult a physician.

Directions

DOSAGE & ADMINISTRATION SECTION

• Directions
clean the affected area at first sign of tingling, burning sensation, or itching.
apply a small amount of this products to the lips and nose prior to exposure to the sun.
in case of cold sore/fever blister indication, apply to area of sensation.
apply up to 4 times a day, and in the evening.
rub in gently.
wash hands before and after applying cream.
do not share product with anyone.
children under 12 years of age: consult a Physician

Uses

OTC - PURPOSE SECTION

Uses

for treatment of cold sores/fever blisters on the lips, face, and/or nose

temporarily relieves the symptoms of itching and pain associated with cold sores/fever blisters

prevents outbreak of cold sore/fever blister if applied at first indication of an out break (tingle, or burning sensation)

heals cold sore/fever blisters

prevents and heals sun burn to lips and stimulates rapid healing

Precautions Allergy alert. When using product, Stop and consult Physician,

OTC - STOP USE SECTION

Warnings

For external use only: Do not use in the eyes, or apply over large areas of the body.

In case of deep or puncture wounds, animal bites, or serious burns, consult a physician.

___________________________________________________________________________________________

Allergy alert: Do not use this product if you are allergic or hypersensitive to any of the ingredients in this product.

___________________________________________________________________________________________

When using this product: Do not get in eyes. Use only as directed.

___________________________________________________________________________________________

Stop using and consult a doctor if the condition persists or gets worse. Do not use longer than 2 weeks unless directed by a doctor.

___________________________________________________________________________________________

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away at 1-800-222-1222.

INDICATIONS & USAGE SECTION

Do not get in eyes. Use only as directed.

Pricipal display panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

PLPDPPLPDP

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
2119083phenol 1.4 % / zinc oxide 20 % Topical OintmentPSN3
2119083phenol 0.014 MG/MG / zinc oxide 0.2 MG/MG Topical OintmentSCD3
2119083Phenol 0.014 MG/MG / ZNO 0.2 MG/MG Topical OintmentSY3

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
ebc62596-fc97-4d03-9483-7ba095d25db7Product name120151210

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
72892-932-72Labisan6.7 mg in 1 TUBEOINTMENT6.73

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72892-932LABISAN (COLD SORE CARE) OINTMENT [LABISAN AMERICAS, LLC.]3Legacy NDC, 1 package rows20200609_81787b60-bd34-67a3-e053-2a91aa0abc75.zip

Products#

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

DailyMed product names page 1 of 1 · 10 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
72892-93272892-932-72

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 8 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
a76b9a3d-5d1a-6021-e053-2995a90a9d8281787b60-bd34-67a3-e053-2a91aa0abc752020-06-06WarningsExact identifier
spl id: a76b9a3d-5d1a-6021-e053-2995a90a9d82
spl set id: 81787b60-bd34-67a3-e053-2a91aa0abc75

Reported adverse events (FAERS/openFDA)#

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