FDA.reportPublic FDA data

Cold Sore Fast-Acting Pain Relief

Manufacturer
Blistex Inc.
Effective date
2025-07-22
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 01:08:22

Label at a glance#

ProductCold Sore Fast-Acting Pain Relief
Active ingredientGLYCERIN, LIDOCAINE
Label structure8 sections

Indications and uses

for the temporary relief of pain and itching associated with fever blisters and cold sores relieves dryness and softens cold sores and fever blisters softens crusts (scabs) associated with cold sores and fever blisters temporarily protects chapped or cracked lips

Dosage and administration

adults and children 2 years of age and older: apply to affected area not more than 3 to 4 times daily children under 2 years of age: do not use, consult a doctor

Storage and handling

push and turn cap to open, close tightly after use wash hands before and after applying www.blistex.com

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

OTC - PURPOSE SECTION

Active ingredientsPurpose
Lidocaine 4.0% (w/w)External analgesic
Glycerin 20% (w/w)Lip protectant

Uses

INDICATIONS & USAGE SECTION

  • for the temporary relief of pain and itching associated with fever blisters and cold sores
  • relieves dryness and softens cold sores and fever blisters
  • softens crusts (scabs) associated with cold sores and fever blisters
  • temporarily protects chapped or cracked lips

Warnings

WARNINGS SECTION

For external use only

OTC - DO NOT USE SECTION

Do not use in large quantities, particularly over raw surfaces or blistered areas

When using this product

OTC - WHEN USING SECTION

  • do 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 within a few days

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

  • adults and children 2 years of age and older: apply to affected area not more than 3 to 4 times daily
  • children under 2 years of age: do not use, consult a doctor

Other information

STORAGE AND HANDLING SECTION

  • push and turn cap to open, close tightly after use
  • wash hands before and after applying www.blistex.com

Inactive ingredients

INACTIVE INGREDIENT SECTION

citric acid, disodium EDTA, ethylhexylglycerin, hydroxyethylcellulose, menthol, phenoxyethanol, potassium sorbate, propylene glycol, purified water

PRINCIPAL DISPLAY PANEL - 4.25 g Tube Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 10157-4103-1

Blistex®
DERMATOLOGIST RECOMMENDED

NEW

COLD SORE

FAST-ACTING
PAIN RELIEF

EXTERNAL ANALGESIC / LIP PROTECTANT

IMMEDIATELY
Relieves Pain & Itching

NET WT. 4.25 g (0.15 oz)

Principal Display Panel - 4.25 g Tube Label
Principal Display Panel - 4.25 g Tube Label

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
2719723glycerin 20 % / lidocaine 4 % Topical GelPSN2
2719723glycerin 0.2 MG/MG / lidocaine 0.04 MG/MG Topical GelSCD2
2719723glycerin 20 % / lidocaine 4 % Topical GelSY2

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
GLYCERIN Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813
LIDOCAINE Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
10157-4103-1Cold Sore Fast-Acting Pain Relief4.25 g in 1 TUBEGEL4.252
10157-4103-1Cold Sore Fast-Acting Pain Relief1 in 1 BLISTER PACKGEL12

Products#

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

DailyMed product names page 1 of 1 · 13 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
10157-410310157-4103-1

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 11 matching rows.

Name, UNII, Kind table
NameUNIIKind
GLYCERINPDC6A3C0OXACTIB
LIDOCAINE98PI200987ACTIB
WATER059QF0KO0RIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
CITRIC ACID MONOHYDRATE2968PHW8QPIACT
HYDROXYETHYL CELLULOSE, UNSPECIFIEDT4V6TWG28DIACT
PHENOXYETHANOLHIE492ZZ3TIACT
ETHYLHEXYLGLYCERIN147D247K3PIACT
POTASSIUM SORBATE1VPU26JZZ4IACT
MENTHOL, UNSPECIFIED FORML7T10EIP3AIACT
EDETATE DISODIUM7FLD91C86KIACT

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
Cold Sore Fast-Acting Pain ReliefGLYCERIN AND LIDOCAINEBlistex Inc.c7511322-dd6c-441c-bf7d-ad4f0c14956a2025-07-22WarningsExact identifier
ndc (package): 10157-4103-1
ndc (product): 10157-4103
ndc11 (package): 10157410301
spl id: a8c93771-4bc0-4fdc-b943-b5920bedb988
spl set id: c7511322-dd6c-441c-bf7d-ad4f0c14956a

Reported adverse events (FAERS/openFDA)#

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