Cold Sore Fast-acting Pain Relief

SPL v2

SPL

SPL Set ID c7511322-dd6c-441c-bf7d-ad4f0c14956a

Route

TOPICAL

Published

Effective Date 2025-07-22

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

Glycerin (200 mg) Lidocaine (40 mg)

Inactive Ingredients

Water Propylene Glycol Citric Acid Monohydrate Hydroxyethyl Cellulose, Unspecified Phenoxyethanol Ethylhexylglycerin Potassium Sorbate Menthol, Unspecified Form Edetate Disodium

Identifiers & Packaging

Marketing Status

OTC MONOGRAPH DRUG Active Since 2025-07-01

Description

Drug Facts

Medication Information

Description

Drug Facts

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

Section 42229-5

Drug Facts

Section 50565-1

Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center right away.

Section 50570-1

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

Section 55105-1

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

Warnings

For external use only

Directions

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

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

Inactive Ingredients

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

When Using This Product

do not get into eyes

Stop Use and Ask A Doctor If

condition worsens
symptoms last more than 7 days or clear up and occur again within a few days

Principal Display Panel 4.25 G Tube Label

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)

Structured Label Content

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

Section 42229-5 (42229-5)

Drug Facts

Section 50565-1 (50565-1)

Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center right away.

Section 50570-1 (50570-1)

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

Section 55105-1 (55105-1)

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

Warnings

For external use only

Directions

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 (Other information)

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

Inactive Ingredients (Inactive ingredients)

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

When Using This Product (When using this product)

do not get into eyes

Stop Use and Ask A Doctor If (Stop use and ask a doctor if)

condition worsens
symptoms last more than 7 days or clear up and occur again within a few days

Principal Display Panel 4.25 G Tube Label (PRINCIPAL DISPLAY PANEL - 4.25 g Tube Label)

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)

Advanced Ingredient Data

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Raw Label Data

All Sections (JSON)

{"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", "42229-5": "Drug Facts", "50565-1": "Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.", "50570-1": "Do not use in large quantities, particularly over raw surfaces or blistered areas", "55105-1": "Active ingredients Purpose Lidocaine 4.0% (w/w) External analgesic Glycerin 20% (w/w) Lip protectant", "Warnings": "For external use only", "Directions": "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": "push and turn cap to open, close tightly after use wash hands before and after applying www.blistex.com", "Inactive ingredients": "citric acid, disodium EDTA, ethylhexylglycerin, hydroxyethylcellulose, menthol, phenoxyethanol, potassium sorbate, propylene glycol, purified water", "When using this product": "do not get into eyes", "Stop use and ask a doctor if": "condition worsens symptoms last more than 7 days or clear up and occur again within a few days", "PRINCIPAL DISPLAY PANEL - 4.25 g Tube Label": "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)"}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:06:36.763644 · Updated: 2026-03-14T23:09:28.158875