FDA.reportPublic FDA data

Herpecin L

Manufacturer
Knowlton Development Corporation Inc
Effective date
2020-07-20
Label type
HUMAN OTC DRUG LABEL
Version
6
Source
legacy-cache
Hydrated at
2026-08-01 23:20:45

Label at a glance#

ProductHerpecin L
Active ingredientDIMETHICONE, MERADIMATE, OCTINOXATE, OCTISALATE, OXYBENZONE
Label structure8 sections

Indications and uses

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

Dosage and administration

adults and children 12 years or over: apply liberally and evenly to affected area on lips at first sign of cold sore and 15 minutes before sun exposure rub in gently but completely for cracking or dryness continue to cover lips until absorbed reapply liberally as often as needed and at least every 2 hours when in sun use a water resistant sunscreen on lips if swimming or sweating children under 12 years : ask a do...

Label contents#

Full prescribing information#

OTC - PURPOSE SECTION

Skin protectant....Sunscreen

OTC - ACTIVE INGREDIENT SECTION

Dimethicone 1%

Meradimate 5%

Octinoxate 7.5%

Octisalate 5%

Oxybenzone 6%

Uses

INDICATIONS & USAGE SECTION

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

Warnings

WARNINGS SECTION

Skin Cancer/Skin Aging Alert: Spending time in the sun increases your risk of skin cancer and early skin aging. This product has been shown only to help prevent sunburn where applied on lips, not skin cancer or early skin aging.

For external use only

SPL UNCLASSIFIED SECTION

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:

  • apply liberally and evenly to affected area on lips at first sign of cold sore and 15 minutes before sun exposure
  • rub in gently but completely
  • for cracking or dryness continue to cover lips until absorbed
  • reapply liberally as often as needed and at least every 2 hours when in sun
  • use a water resistant sunscreen on lips if swimming or sweating

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 (hybrid sunflower) oil, petrolatum, ozokerite, mineral oil, microcrystalline wax, talc, titanium dioxide, beeswax, melissa officinalis (balm mint) extract, cetyl lactate, glyceryl laurate, flavor, lysine HCI, ascorbyl palmitate, tocopheryl acetate, pyridoxine HCI, panthenol, BHT (244-014)

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

FAST ACTING RELIEF

Herpecin L ®

Real Relief from Real Medicine.

Helps Treat, Protect & Relieve

Cold Sores, Sun & Fever Blisters, Chapped Lips SPF 30

NET WT 0.1 OZ (2.8g)

PRINCIPAL DISPLAY PANEL Herpecin L® SPF 30 NET WT 0.1 OZ (2.8g)PRINCIPAL DISPLAY PANEL Herpecin L® SPF 30 NET WT 0.1 OZ (2.8g)

Products#

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

DailyMed product names page 1 of 1 · 24 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
54565-320154565-3201-1, 54565-3201-2

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 22 matching rows.

Name, UNII, Kind table
NameUNIIKind
HELIANTHUS ANNUUS FLOWERING TOPBKJ0J3D1BPIACT
PETROLATUM4T6H12BN9UIACT
CERESINQ1LS2UJO3AIACT
MINERAL OILT5L8T28FGPIACT
MICROCRYSTALLINE WAXXOF597Q3KYIACT
TALC7SEV7J4R1UIACT
TITANIUM DIOXIDE15FIX9V2JPIACT
APIS MELLIFERA7S82P3R43ZIACT
MELISSA OFFICINALISYF70189L0NIACT
CETYL LACTATEA7EVH2RK4OIACT
GLYCERYL LAURATEY98611C087IACT
LYSINE HYDROCHLORIDEJNJ23Q2COMIACT
ASCORBYL PALMITATEQN83US2B0NIACT
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0IACT
PYRIDOXINE HYDROCHLORIDE68Y4CF58BVIACT
PANTHENOLWV9CM0O67ZIACT
BUTYLATED HYDROXYTOLUENE1P9D0Z171KIACT
DIMETHICONE92RU3N3Y1OACTIB
MERADIMATEJ9QGD60OUZACTIB
OCTINOXATE4Y5P7MUD51ACTIB
OCTISALATE4X49Y0596WACTIB
OXYBENZONE95OOS7VE0YACTIB

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
aae5242b-1188-5717-e053-2a95a90a1a865d1a0eee-9d07-6442-e053-2a91aa0ab9e32020-07-20WarningsExact identifier
spl id: aae5242b-1188-5717-e053-2a95a90a1a86
spl set id: 5d1a0eee-9d07-6442-e053-2a91aa0ab9e3

Reported adverse events (FAERS/openFDA)#

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