Helocaine Cold Sore Fever Blister Treatment

openFDA label record#

This page contains supplementary openFDA label data. For the canonical label presentation, use the corresponding DailyMed Structured Product Label.

Verified complete openFDA source JSON (canonical bytes are SHA-256 checked before publication)

Brand name: Helocaine Cold Sore Fever Blister Treatment
Generic name: TETRACAINE, MINERAL
Manufacturer: Pagari Life Science Corp.
Product type: HUMAN OTC DRUG
SPL set ID: 1b2eae09-5de0-9219-e063-6294a90af046
SPL ID: 487041f0-3ef3-7c82-e063-6394a90aac74
Version: 2
Effective date: 2026-01-15
Source export date: 2026-11-06
Source partition: 12
Source file: https://download.open.fda.gov/drug/label/drug-label-0012-of-0014.json.zip
Source object key: raw/openfda/drug-label/2026-11-06/8ec9b1418c25a8bb472a36e6bc0b2cbabb210d48d5dd734197e022d21529ed58/drug-label-0012-of-0014.json.zip
Source manifest SHA-256: 8dff71fbef1291eb7711013e9a3a06194930757924a8946ae3034107a98d9463
Import run: 20261106T075659Z
Imported at: 2026-11-06 09:17:27

Harmonized routes table
Harmonized routes
TOPICAL

Harmonized identifier links#

Every typed identifier imported from the complete openFDA harmonization object is paginated here; values are not reduced to a first match.

Harmonized identifiers page 1 of 1 · 12 matching rows.

Type, Scope, Identifier table
Type	Scope	Identifier	Source field
application number		M017	openfda.application_number
brand name		Helocaine Cold Sore Fever Blister Treatment	openfda.brand_name
generic name		TETRACAINE, MINERAL	openfda.generic_name
manufacturer name		Pagari Life Science Corp.	openfda.manufacturer_name
ndc	package	83609-212-02	openfda.package_ndc
ndc	product	83609-212	openfda.product_ndc
ndc11	package	83609021202	derived:openfda.package_ndc
rxcui		2685213	openfda.rxcui
spl id		487041f0-3ef3-7c82-e063-6394a90aac74	id
spl set id		1b2eae09-5de0-9219-e063-6294a90af046	set_id
unii		0619F35CGV	openfda.unii
unii		T5L8T28FGP	openfda.unii

Warnings cross-check#

openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.

Warnings sections page 1 of 1 · 1 matching rows.

warnings

Warnings For external use only. Do not use on • deep or puncture wounds • animal bites • serious burns 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 allergic reaction (blister or rash worsens) to any of the ingredients Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center

Reported adverse events (FAERS/openFDA)#

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