Active Ingredient:

Manufacturer
S.S.S. Company
Effective date
2026-10-07
Label type
HUMAN OTC DRUG LABEL
Version
8
Source
daily-update
Hydrated at
2026-10-10 01:02:53

Label at a glance#

ProductCurasore
Active ingredientPRAMOXINE HYDROCHLORIDE
Label structure8 sections

Indications and uses

For the temporary relief of pain and itching associated with fever blisters and cold sores

Dosage and administration

Adults and children 2 years of age and older: Apply to affected area not more than 3 to 4 times daily; avoid moistening area for 2 to 3 minutes following application. Children under 2 years of age: consult a doctor.

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

DRUG FACTS

Active Ingredient:

OTC - ACTIVE INGREDIENT SECTION

Pramoxine Hydrochloride 1%

Purpose:

OTC - PURPOSE SECTION

Local Anesthetic

Uses

INDICATIONS & USAGE SECTION

For the temporary relief of pain and itching associated with fever blisters and cold sores

Warnings

WARNINGS SECTION

For external use only

When using this product

OTC - WHEN USING SECTION

  • Do not swallow
  • Avoid contact with the eyes
  • Avoid contact with the nose
OTC - STOP USE SECTION

Stop use and consult a doctor If

  • Redness
  • Swelling
  • Irritation or pain persists or increases, condition worsens, or if symptoms persist for more than 7 days or clear up and occur again within a few days, discontinue use of this product and consult a doctor.

Keep out of the reach of children

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

In case of accidental ingestion, get medical help or contact a Poison Control Center immediately.

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; avoid moistening area for 2 to 3 minutes following application. Children under 2 years of age: consult a doctor.

Other Information

SPL UNCLASSIFIED SECTION

  • FLAMMABLE
  • Keep away from heat, sparks, and open flame
  • Store in a cool place
  • Keep lid tightly capped.
  • To report an adverse event or obtain product information contact (404) 521-0857.

Inactive Ingredients

INACTIVE INGREDIENT SECTION

ethyl alcohol and ethyl ether

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 12258-223-05

CURASORE®

Pain Relieving Anesthetic for

Fever Blisters • Cold Sores

Contains Ether

0.5 FL OZ (15mL)

Important: Begin application at the

first sign of a fever blister or cold

sore.

CURASORE®

Analgesic-Anesthetic-Antipruritic

for Relieving Pain & Itching of

Fever Blisters & Cold Sores

With

DISPOSABLE COTTON APPLICATORS

Other Packaging Content

Manufactured by S.S.S. Company, Atlanta, GA 30315, USA

ssspharmaceuticals.com

Rev. E

Principal Display Panel
Principal Display Panel

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
58f3f9b7-3b9b-a9c1-1c9f-18ac777192b8Product name120140508
a7051cba-790b-a699-81f8-dbbbdbd9b5acProduct name120140508
da108d9e-edc8-17a3-8c28-3251c6a8acccProduct name120140508

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
Pramoxine HydrochlorideACTIVE INGREDIENT88AYB867L51
PramoxineACTIVE MOIETY068X84E0561
alcoholINACTIVE INGREDIENT3K9958V90M1
etherINACTIVE INGREDIENT0F5N573A2Y1

Products#

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

DailyMed product names page 1 of 1 · 5 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
12258-22312258-223-05

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 3 matching rows.

Name, UNII, Kind table
NameUNIIKind
PRAMOXINE HYDROCHLORIDE88AYB867L5ACTIB
ALCOHOL3K9958V90MIACT
ETHER0F5N573A2YIACT

Source Document#

Source XML · Source PDF

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
72026-01-08full-release2026-06-01 01:32:05

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 1 · 30 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
alcoholALCOHOL3K9958V90MLIQUID / INTRAMUSCULAR400 mgExact identifier — unii+dosage form
30 equally ranked IID candidates
alcoholALCOHOL3K9958V90MSHAMPOO / TOPICAL714 mgExact identifier — unii+route
30 equally ranked IID candidates
alcoholALCOHOL3K9958V90MSPRAY / TOPICAL3633 mgExact identifier — unii+route
30 equally ranked IID candidates
alcoholALCOHOL3K9958V90MSHAMPOO / TOPICAL714 mgExact identifier — unii+route
30 equally ranked IID candidates
alcoholALCOHOL3K9958V90MAEROSOL / TOPICAL561 mgExact identifier — unii+route
30 equally ranked IID candidates
alcoholALCOHOL3K9958V90MAEROSOL, FOAM / TOPICAL4504 mgExact identifier — unii+route
30 equally ranked IID candidates
alcoholALCOHOL3K9958V90MLIQUID / ORAL3563 mgExact identifier — unii+dosage form
30 equally ranked IID candidates
alcoholALCOHOL3K9958V90MGEL / TOPICAL9971 mgExact identifier — unii+route
30 equally ranked IID candidates
alcoholALCOHOL3K9958V90MAEROSOL, SPRAY / TOPICAL561 mgExact identifier — unii+route
30 equally ranked IID candidates
alcoholALCOHOL3K9958V90MLIQUID / RESPIRATORY (INHALATION)5 %w/wExact identifier — unii+dosage form
30 equally ranked IID candidates
alcoholALCOHOL3K9958V90MSOLUTION / TOPICAL2445 mgExact identifier — unii+route
30 equally ranked IID candidates
alcoholALCOHOL3K9958V90MGEL, METERED / TOPICAL541 mgExact identifier — unii+route
30 equally ranked IID candidates
alcoholALCOHOL3K9958V90MSPRAY / TOPICAL3633 mgExact identifier — unii+route
30 equally ranked IID candidates
alcoholALCOHOL3K9958V90MSOLUTION / TOPICAL2445 mgExact identifier — unii+route
30 equally ranked IID candidates
alcoholALCOHOL3K9958V90MPOWDER, FOR SOLUTION / TOPICAL40 %w/wExact identifier — unii+route
30 equally ranked IID candidates
alcoholALCOHOL3K9958V90MPOWDER, FOR SOLUTION / TOPICAL40 %w/wExact identifier — unii+route
30 equally ranked IID candidates
alcoholALCOHOL3K9958V90MAEROSOL, FOAM / TOPICAL4504 mgExact identifier — unii+route
30 equally ranked IID candidates
alcoholALCOHOL3K9958V90MGEL, METERED / TOPICAL541 mgExact identifier — unii+route
30 equally ranked IID candidates
alcoholALCOHOL3K9958V90MGEL / TOPICAL9971 mgExact identifier — unii+route
30 equally ranked IID candidates
alcoholALCOHOL3K9958V90MLIQUID / RESPIRATORY (INHALATION)5 %w/wExact identifier — unii+dosage form
30 equally ranked IID candidates
alcoholALCOHOL3K9958V90MLIQUID / INTRAMUSCULAR400 mgExact identifier — unii+dosage form
30 equally ranked IID candidates
alcoholALCOHOL3K9958V90MSWAB / TOPICAL2250 mgExact identifier — unii+route
30 equally ranked IID candidates
alcoholALCOHOL3K9958V90MLIQUID / ORAL3563 mgExact identifier — unii+dosage form
30 equally ranked IID candidates
alcoholALCOHOL3K9958V90MLIQUID / INTRAVENOUS400 mgExact identifier — unii+dosage form
30 equally ranked IID candidates
alcoholALCOHOL3K9958V90MAEROSOL / TOPICAL561 mgExact identifier — unii+route
30 equally ranked IID candidates
alcoholALCOHOL3K9958V90MSWAB / TOPICAL2250 mgExact identifier — unii+route
30 equally ranked IID candidates
alcoholALCOHOL3K9958V90MLIQUID / INTRAVENOUS400 mgExact identifier — unii+dosage form
30 equally ranked IID candidates
alcoholALCOHOL3K9958V90MLOTION / TOPICAL25 %w/wExact identifier — unii+route
30 equally ranked IID candidates
alcoholALCOHOL3K9958V90MAEROSOL, SPRAY / TOPICAL561 mgExact identifier — unii+route
30 equally ranked IID candidates
alcoholALCOHOL3K9958V90MLOTION / TOPICAL25 %w/wExact identifier — unii+route
30 equally ranked IID candidates

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
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
CurasorePRAMOXINE HYDROCHLORIDES.S.S. Company6891e5aa-e6f2-4355-8ee9-d23c9959787e2026-01-08WarningsExact identifier
ndc (package): 12258-223-05
ndc (product): 12258-223
ndc11 (package): 12258022305
spl set id: 6891e5aa-e6f2-4355-8ee9-d23c9959787e

Reported adverse events (FAERS/openFDA)#

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