COLD SORE FAST-ACTING PAIN RELIEF- glycerin and lidocaine gel

Cold Sore Fast-Acting Pain Relief by

Drug Labeling and Warnings

Cold Sore Fast-Acting Pain Relief by is a Otc medication manufactured, distributed, or labeled by Blistex Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

ACTIVE INGREDIENT

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

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

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

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

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)

INGREDIENTS AND APPEARANCE

COLD SORE FAST-ACTING PAIN RELIEF 
glycerin and lidocaine gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 10157-4103
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
GLYCERIN (UNII: PDC6A3C0OX) (GLYCERIN - UNII:PDC6A3C0OX)	GLYCERIN	200 mg  in 1 g
LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987)	LIDOCAINE	40 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
HYDROXYETHYL CELLULOSE, UNSPECIFIED (UNII: T4V6TWG28D)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A)
EDETATE DISODIUM (UNII: 7FLD91C86K)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 10157-4103-1	1 in 1 BLISTER PACK	07/01/2025
1		4.25 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph drug	M017	07/01/2025

Labeler - Blistex Inc. (005126354)

Establishment
Name	Address	ID/FEI	Business Operations
Blistex Inc.		005126354	MANUFACTURE(10157-4103)