Cold Sore Treatment

Manufacturer
Army & Air Force Exchange Service
Effective date
2021-02-09
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
legacy-cache
Hydrated at
2026-08-01 22:53:39

Label at a glance#

ProductCold Sore Treatment
Active ingredientCAMPHOR (SYNTHETIC), BENZALKONIUM CHLORIDE
Label structure9 sections

Indications and uses

• for treatment of cold sores/fever blisters on the face or lips • temporarily relieves the symptoms of itching and pain associated with cold sores/fever blisters • first aid to help protect against infection in minor cuts, scrapes, burns, and sores

Dosage and administration

• clean the affected area • apply a small amount of this product to the affected area 1 to 3 times daily • rub in gently • wash hands before and after applying the product • do not share this product with anyone • children under 12 years of age : ask a doctor

Storage and handling

store at room temperature

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Benzalkonium Chloride 0.13%

Camphor 3.0%

Purpose

OTC - PURPOSE SECTION

Cold Sore/Fever Blister Treatment/First Aid Antiseptic

Uses

INDICATIONS & USAGE SECTION

  • for treatment of cold sores/fever blisters on the face or lips
  • temporarily relieves the symptoms of itching and pain associated with cold sores/fever blisters
  • first aid to help protect against infection in minor cuts, scrapes, burns, and sores

Warnings

WARNINGS SECTION

  • For external use only: Do not use in the eyes or apply over large areas of the body. In case of deep or puncture wounds, animal bites or serious burns, consult a physician.
  • Allergy Alert: Do not use if you are allergic to any of the ingredients in this product.

When using this product

OTC - WHEN USING SECTION

avoid contact with eyes. Use only as directed.

Stop use and consult a doctor if

OTC - STOP USE SECTION

the condition persists or gets worse. Do not use longer than 1 week unless directed by a doctor.

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 right away at 1-800-222-1222.

Directions

DOSAGE & ADMINISTRATION SECTION

  • clean the affected area
  • apply a small amount of this product to the affected area 1 to 3 times daily
  • rub in gently
  • wash hands before and after applying the product
  • do not share this product with anyone
  • children under 12 years of age: ask a doctor

Other information

STORAGE AND HANDLING SECTION

store at room temperature

Inactive ingredients

INACTIVE INGREDIENT SECTION

alcohol, aloe barbadensis leaf juice, arginine, butylparaben, cetearyl isononanoate, ethylparaben, eucalyptus globulus leaf oil, hexcyldecanol, hexyldecyl laurate, melaleuca alternifolia (tea tree) leaf oil, menthol, methylparaben, ozokerite, phenoxyethanol, poloxamer 407, propylparaben, thymol, tocopheryl nicotinate (vitamin e), zinc chloride

Questions or comments?

OTC - QUESTIONS SECTION

Call us toll-free at 1-877-242-3234 Monday-Friday, 9 a.m. to 5 p.m. EST.

Serious side effects associated with use of this product may be reported to this number.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

ExchangeSelectColdSoreTube60234.jpg
ExchangeSelectColdSoreTube60234.jpg

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
55301-407-012021-02-09C16284748780-1ba0f9c33-490e-a910-e053-dadaa90a0b85BPC 407 Cold Sore Treatment – Drug Facts
55301-407-012021-01-29C16284748780-1ba0f9c33-490e-a910-e053-dadaa90a0b85BPC 407 Cold Sore Treatment – Drug Facts

Products#

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

DailyMed product names page 1 of 1 · 26 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
55301-40755301-407-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 23 matching rows.

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
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
93f9d50b-8908-4a57-bf2a-cc46196b41c3971746f4-4cd5-596d-e053-2995a90a88b62021-12-13WarningsExact identifier
spl set id: 971746f4-4cd5-596d-e053-2995a90a88b6

Reported adverse events (FAERS/openFDA)#

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