FDA.reportPublic FDA data

Campho-Phenique

Manufacturer
Foundation Consumer Healthcare LLC
Effective date
2024-12-02
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-06-01 00:39:59

Label at a glance#

ProductCampho-Phenique Cold Sore Treatment
Active ingredientCAMPHOR (SYNTHETIC), PHENOL
Label structure11 sections

Indications and uses

for temporary relief of pain and itching associated with cold sores and fever blisters first aid to help prevent infection

Dosage and administration

adults and children 2 years of age and over: clean the affected area apply a small amount of this product to the cold sore or fever blister 1 to 3 times daily do not bandage children under 2 years of age: ask a doctor

Storage and handling

store at room temperature. Avoid excessive heat above 40°C (104°F). close cap tightly after use

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Camphorated phenol (camphor 10.8% and phenol 4.7%)

Purposes

OTC - PURPOSE SECTION

Pain reliever/antiseptic

Uses

INDICATIONS & USAGE SECTION

  • for temporary relief of pain and itching associated with cold sores and fever blisters
  • first aid to help prevent infection

Warnings

WARNINGS SECTION

For external use only

Do not use

OTC - DO NOT USE SECTION

  • over large areas of the body
  • with a bandage

Ask a doctor before use if you have

OTC - ASK DOCTOR SECTION

  • a deep or puncture wound
  • animal bites
  • serious burns

OTC - WHEN USING SECTION

When using this productdo not use in or near the eyes. If contact occurs, rinse eyes thoroughly with water and obtain medical attention.

Stop use and ask a doctor if

OTC - STOP USE SECTION

  • condition worsens
  • symptoms persist for more than 7 days or clear up and occur again within a few days

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.If swallowed, get medical help or contact a Poison Control Center right away. Do not induce vomitingbefore contacting medical help or a Poison Control Center.

Directions

DOSAGE & ADMINISTRATION SECTION

  • adults and children 2 years of age and over:
    • clean the affected area
    • apply a small amount of this product to the cold sore or fever blister 1 to 3 times daily
    • do not bandage
  • children under 2 years of age: ask a doctor

Other information

STORAGE AND HANDLING SECTION

  • store at room temperature. Avoid excessive heat above 40°C (104°F).
  • close cap tightly after use

Inactive ingredients

INACTIVE INGREDIENT SECTION

light mineral oil, colloidal silicon dioxide, aloe barbadensis leaf extract, glycerin, eucalyptus oil

Questions or comments?

OTC - QUESTIONS SECTION

1-855-602-2676weekdays 9 AM to 5 PM EST

SPL UNCLASSIFIED SECTION

Dist. by:
Foundation Consumer Healthcare, LLC.
Pittsburgh, PA 15205

PRINCIPAL DISPLAY PANEL - 6.5 g Tube Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

with
aloe

MAXIMUM STRENGTH

MEDICATED
CAMPHO
PHENIQUE ®

COLD SORE
TREATMENT GEL

Fights cold sores with a powerful formula to:

immediately relieve
pain & itch

dry
cold sore

moisturize
surrounding area

Helps prevent infection

NET WT 0.23 OZ (6.5 g)

PRINCIPAL DISPLAY PANEL - 6.5 g Tube Carton
PRINCIPAL DISPLAY PANEL - 6.5 g Tube Carton

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
210347Campho-Phenique 10.8 % / 4.7 % Topical GelPSN4
308939camphor 10.8 % / phenol 4.7 % Topical GelPSN4
210347camphor 0.108 MG/MG / phenol 0.047 MG/MG Topical Gel [Campho-Phenique]SBD4
308939camphor 0.108 MG/MG / phenol 0.047 MG/MG Topical GelSCD4
210347Campho-Phenique (camphor 10.8 % / phenol 4.7 % ) Topical GelSY4
308939camphor 0.11 MG/MG / phenol 0.05 MG/MG Topical GelSY4
308939camphor 10.8 % / phenol 4.7 % Topical GelSY4

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69536-108-23Campho-PheniqueCold Sore Treatment1 in 1 CARTONGEL14
69536-108-23Campho-PheniqueCold Sore Treatment6.5 g in 1 TUBEGEL6.54

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69536-108CAMPHO-PHENIQUE COLD SORE TREATMENT (CAMPHOR (SYNTHETIC) AND PHENOL) GEL [FOUNDATION CONSUMER HEALTHCARE LLC]4Current NDC, Legacy NDC, 2 package rows20241204_106c0bb2-f2e2-4255-867d-d09ff6a5a2e6.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
69536-108-23GM - Gram69536-108b40c8512-2d68-44e7-ac9a-7b8c3944fec412018-07-03

Products#

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

DailyMed product names page 1 of 1 · 9 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
69536-10869536-108-23

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 7 matching rows.

Name, UNII, Kind table
NameUNIIKind
SILICON DIOXIDEETJ7Z6XBU4IACT
EUCALYPTUS OIL2R04ONI662IACT
GLYCERINPDC6A3C0OXIACT
LIGHT MINERAL OILN6K5787QVPIACT
ALOE VERA LEAFZY81Z83H0XIACT
CAMPHOR (SYNTHETIC)5TJD82A1ETACTIB
PHENOL339NCG44TVACTIB

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
Campho-Phenique Cold Sore TreatmentCAMPHOR (SYNTHETIC) AND PHENOLFoundation Consumer Healthcare LLC106c0bb2-f2e2-4255-867d-d09ff6a5a2e62024-12-02WarningsExact identifier
ndc (package): 69536-108-23
ndc (product): 69536-108
ndc11 (package): 69536010823
spl id: 284cb346-f76b-53af-e063-6394a90a2aa4
spl set id: 106c0bb2-f2e2-4255-867d-d09ff6a5a2e6

Reported adverse events (FAERS/openFDA)#

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