Helocaine Cold Sore Fever Blister Treatment

Manufacturer: Pagari Life Science Corp.
Effective date: 2026-01-15
Label type: HUMAN OTC DRUG LABEL
Version: 2
Source: full-release
Hydrated at: 2026-06-01 01:33:00

Label at a glance#

ProductHelocaine Cold Sore Fever Blister Treatment

Active ingredientTETRACAINE, MINERAL OIL

Label structure8 sections

Indications and uses

for the temporary relief of pain and itching associated with fever blisters and cold sores helps prevent and temporarily protects chapped or cracked lips helps prevent and protect from the drying effects of wind and cold weather

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 the age of 2 consult a doctor

Contacts and useful links#

PhoneLabel contact(877) 513-3057

Label contents#

Full prescribing information#

Active ingredients

OTC - ACTIVE INGREDIENT SECTION

Tetracaine 2%

Mineral oil 74.4%

Purpose

OTC - PURPOSE SECTION

Topical analgesic

Skin protectant

Uses

INDICATIONS & USAGE SECTION

for the temporary relief of pain and itching associated with fever blisters and cold sores
helps prevent and temporarily protects chapped or cracked lips
helps prevent and protect from the drying effects of wind and cold weather

Warnings

WARNINGS SECTION

For external use only.

Do not use

OTC - DO NOT USE SECTION

on • deep or puncture wounds • animal bites • serious burns
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
allergic reaction (blister or rash worsens) to any of the ingredients

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

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 the age of 2

consult a doctor

Other information

OTHER SAFETY INFORMATION

store at 20º - 25º C (68º - 77º F)

Inactive ingredients

INACTIVE INGREDIENT SECTION

peppermint oil, polyethylene, polyethylene oxide, polyethylene glycol, sodium carboxymethylcellulose

Questions or comments?

OTC - QUESTIONS SECTION

call 1- (877) 513-3057 (toll-free)

Package labeling

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

labelLabel 2

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	SPL version
2685213	mineral oil 74.4 % / tetracaine 2 % Topical Ointment	PSN	2
2685213	mineral oil 0.744 MG/MG / tetracaine 0.02 MG/MG Topical Ointment	SCD	2
2685213	mineral oil 74.4 % / tetracaine 2 % Topical Ointment	SY	2

DailyMed Pharmacologic Classes#

Class, Version, Type table
Class	Version	Type	Effective
TETRACAINE Pharmacologic Class Indexing	2	Indexing - Pharmacologic Class	20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
a26f29b9-6919-4f09-a354-491df8d2b97d	Product name	1	20251021
122d1fa8-7b9e-49b4-89ce-b062ffd1d947	Product name	1	20181030
a993dfc5-f219-4460-bde6-30dd724d9ef0	Product name	1	20160818
4d7ae718-ed00-bae8-2abe-9eaec1eef7ff	Product name	1	20140508
9137811f-f279-8640-5aeb-99fa2145d64d	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
83609-212-02	Helocaine Cold Sore Fever Blister Treatment	3 g in 1 TUBE	OINTMENT	3		2
83609-212-02	Helocaine Cold Sore Fever Blister Treatment	1 in 1 BOX	OINTMENT	1		2

Products#

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

DailyMed product names page 1 of 1 · 8 matching rows.

Helocaine Cold Sore Fever Blister Treatment
TETRACAINE, MINERAL
HIGH DENSITY POLYETHYLENE
TETRACAINE
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM
POLYETHYLENE GLYCOL, UNSPECIFIED
MINERAL OIL
PEPPERMINT OIL

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
83609-212	83609-212-02

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 6 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
HIGH DENSITY POLYETHYLENE	UG00KM4WR7	IACT
TETRACAINE	0619F35CGV	ACTIB
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM	K679OBS311	IACT
POLYETHYLENE GLYCOL, UNSPECIFIED	3WJQ0SDW1A	IACT
MINERAL OIL	T5L8T28FGP	ACTIB
PEPPERMINT OIL	AV092KU4JH	IACT

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
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Helocaine Cold Sore Fever Blister Treatment	TETRACAINE, MINERAL	Pagari Life Science Corp.	1b2eae09-5de0-9219-e063-6294a90af046	2026-01-15	Warnings	Exact identifier ndc (package): 83609-212-02 ndc (product): 83609-212 ndc11 (package): 83609021202 spl id: 487041f0-3ef3-7c82-e063-6394a90aac74 spl set id: 1b2eae09-5de0-9219-e063-6294a90af046

Reported adverse events (FAERS/openFDA)#

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