Cold Sore Fast-acting Pain Relief Gel
FDA Label NDC 10157-4103

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Blistex Inc. for the product Cold Sore Fast-acting Pain Relief (NDC 10157-4103). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding other, otc - purpose, uses, warnings, otc - do not use, when using this product, stop use and ask a doctor if, otc - keep out of reach of children, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

→ Other

→ Otc - Purpose

→ Uses

→ Warnings

→ Otc - Do Not Use

→ When Using This Product

→ Stop Use And Ask A Doctor If

→ Otc - Keep Out Of Reach Of Children

→ Directions

→ Other Information

→ Inactive Ingredients

→ Principal Display Panel - 4.25 G Tube Label

Other

Drug Facts

Otc - Purpose

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

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

Warnings

For external use only

Otc - Do Not Use

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

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

Otc - Keep Out Of Reach Of Children

Keep out of reach of children.

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

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