FDA.reportPublic FDA data

Herpecin L

Manufacturer
Focus Consumer Healthcare, LLC
Effective date
2026-01-26
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 01:34:55

Label at a glance#

ProductHerpecin L
Active ingredientDIMETHICONE, ZINC OXIDE
Label structure12 sections

Indications and uses

helps protect and relieve cold sores/fever blisters helps prevent sunburn on lips relieves dry chapped lips

Dosage and administration

adults and children 12 years or over: at first sign of a cold sore, apply liberally at least 4 times a day to affected area on lips as a protectant, aply liberally to lips as often as needed or at least twice daily for cracking and dryness continue to cover lips until absorbed apply liberally 15 minutes before sun exposure and at least every 2 hours when in sun use a water resistant sunscreen on lips if swimming o...

Label contents#

Full prescribing information#

Active ingredients

OTC - ACTIVE INGREDIENT SECTION

Zinc Oxide 20%

Dimethicone 6%

Purpose

OTC - PURPOSE SECTION

Sunscreen

Skin protectant

Uses

INDICATIONS & USAGE SECTION

  • helps protect and relieve cold sores/fever blisters
  • helps prevent sunburn on lips
  • relieves dry chapped lips

Warnings

WARNINGS SECTION

For external use only

Do not use

OTC - DO NOT USE SECTION

  • on broken skin
  • if you are allergic to any ingredient in this product

When using this product

OTC - WHEN USING SECTION

  • keep out of eyes. Rinse with water to remove.
  • apply only to affected areas
  • avoid applying directly inside your mouth
  • do not share this product with anyone since this may spread infection

Stop use and ask a doctor if

OTC - STOP USE SECTION

  • rash occurs, condition worsens or does not improve within 7 days

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

adults and children 12 years or over:

  • at first sign of a cold sore, apply liberally at least 4 times a day to affected area on lips
  • as a protectant, aply liberally to lips as often as needed or at least twice daily
  • for cracking and dryness continue to cover lips until absorbed
  • apply liberally 15 minutes before sun exposure and at least every 2 hours when in sun
  • use a water resistant sunscreen on lips if swimming or sweating
  • Sun protection measures: Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularily use a sunscreen with a Broad Spectrum SPF value of 15 or higher and other sun protection measures including:
  • limit time in sun, especially from 10am - 2pm
  • Wear long-sleeved shirts, pants, hats and sunglasses

children under 12 years: ask a doctor

Other information

SPL UNCLASSIFIED SECTION

  • protect the product in this container from excessive heat and direct sun

Inactive ingredients

INACTIVE INGREDIENT SECTION

helianthus annuus (sunflower) seed oil, ozokerite, butyloctyl salicylate, caprylic/capric triglyceride, simmondsia chinensis (jojoba) seed oil, C10-30 cholesterol/lanosterol esters, tribehenin, microcrystalline wax, polyhydroxystearic acid, silica, fragrance (parfum), tetrahexyldecyl ascorbate, lauroyl lysine, zingibar officinale (ginger) root extract, melissa officinalis extract, aloe barbadensis leaf extract, tocopherol, tocopheryl acetate, carthamus tinctorius (safflower) seed oil, glycine soja (soybean) oil, polyglyceryl-3 polyricinoleate, isostearic acid, lecithin, bisabolol

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

PDPPDP

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
DIMETHICONE Pharmacologic Class Indexing3Indexing - Pharmacologic Class20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
baf7f49c-75b6-496b-a00e-8e766a8e4f03Product name120210127
ebc62596-fc97-4d03-9483-7ba095d25db7Product name120151210
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71687-7774-1Herpecin L2.8 g in 1 TUBESTICK2.81
71687-7774-1Herpecin L2 in 1 CARTONSTICK21
71687-7774-2Herpecin L2.8 g in 1 TUBESTICK2.81
71687-7774-2Herpecin L1 in 1 CARTONSTICK11

Products#

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

DailyMed product names page 1 of 1 · 27 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
71687-777471687-7774-2, 71687-7774-1

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 25 matching rows.

Name, UNII, Kind table
NameUNIIKind
SAFFLOWER OIL65UEH262ISIACT
SOYBEAN OIL241ATL177AIACT
ISOSTEARIC ACIDX33R8U0062IACT
POLYHYDROXYSTEARIC ACID (2300 MW)YXH47AOU0FIACT
SUNFLOWER OIL3W1JG795YIIACT
SIMMONDSIA CHINENSIS (JOJOBA) SEED OIL724GKU717MIACT
CERESINQ1LS2UJO3AIACT
BUTYLOCTYL SALICYLATE2EH13UN8D3IACT
C10-30 CHOLESTEROL/LANOSTEROL ESTERS137SL7IL0YIACT
TRIBEHENIN8OC9U7TQZ0IACT
MICROCRYSTALLINE WAXXOF597Q3KYIACT
SILICON DIOXIDEETJ7Z6XBU4IACT
LEMON BALM OILMJ76269K9SIACT
.ALPHA.-TOCOPHEROLH4N855PNZ1IACT
BISABOLOL24WE03BX2TIACT
LAUROYL LYSINE113171Q70BIACT
ZINGIBER OFFICINALE (GINGER) ROOT OILSAS9Z1SVUKIACT
ALOE BARBADENSIS LEAF JUICERUE8E6T4NBIACT
TETRAHEXYLDECYL ASCORBATE9LBV3F07AZIACT
CAPRYLIC/CAPRIC TRIGLYCERIDEC9H2L21V7UIACT
DIMETHICONE92RU3N3Y1OACTIB
ZINC OXIDESOI2LOH54ZACTIB
POLYGLYCERYL-3 RICINOLEATEMZQ63P0N0WIACT
ALPHA-TOCOPHEROL ACETATE9E8X80D2L0IACT
LECITHIN, SUNFLOWER834K0WOS5GIACT

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
Herpecin LZINC OXIDE, DIMETHICONEFocus Consumer Healthcare, LLC488a29c3-dd97-af1a-e063-6394a90aba7f2026-01-26WarningsExact identifier
ndc (package): 71687-7774-1
ndc (package): 71687-7774-2
ndc (product): 71687-7774
ndc11 (package): 71687777401
ndc11 (package): 71687777402
spl id: 48838b8d-ebd8-cd22-e063-6294a90a6802
spl set id: 488a29c3-dd97-af1a-e063-6394a90aba7f

Reported adverse events (FAERS/openFDA)#

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