Leader Camphor Phenol Gel

Manufacturer
Cardinal Health (Leader) | OraLabs, Inc.
Effective date
2014-04-22
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
legacy-cache
Hydrated at
2026-08-02 01:36:33

Label at a glance#

ProductLeader Camphor Phenol Gel
Active ingredientCAMPHOR (SYNTHETIC), PHENOL
Label structure8 sections

Indications and uses

For the 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 or over: clean the affected area. Apply directly to the cold sore or fever blister 1 to 3 times daily. Do not bandage. Children under 2 years: ask a doctor.

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Camphor (10.8%), Phenol (4.7%)

Purpose

OTC - PURPOSE SECTION

Pain reliever/antiseptic

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. Do not induce vomiting before contacting medical help or a Poison Control Center.

Uses

INDICATIONS & USAGE SECTION

For the 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 over large areas of the body or with a bandage. Ask a doctor before use if you have a deep or puncture wound. Animal bites. Serious burns. When using this product do not use near the eye. If contact occurs, rinse eyes thoroughly with water and obtain medical attention.

Directions

DOSAGE & ADMINISTRATION SECTION

Adults and children 2 years or over: clean the affected area. Apply directly to the cold sore or fever blister 1 to 3 times daily. Do not bandage. Children under 2 years: ask a doctor.

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Eucalyptus, Glycerin, Mineral Oil, Silica.

Package/Label Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Leader Camphor Phenol Box.jpg
Leader Camphor Phenol Box.jpg

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
37205-751-232025-04-25C16284748780-19d75b9cf-f76d-f424-e053-dadaa90a57ceDrug Facts
37205-751-232020-01-31C16284748780-19d75b9cf-f76d-f424-e053-dadaa90a57ceDrug Facts

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
37205-751-23GM - Gram37205-7512ca34da7-4e21-43fb-8255-fd7c859ebb8c12014-05-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
CAMPHOR (SYNTHETIC)ACTIVE INGREDIENT5TJD82A1ET1
PHENOLACTIVE INGREDIENT339NCG44TV1
CAMPHOR (SYNTHETIC)ACTIVE MOIETY5TJD82A1ET1
PHENOLACTIVE MOIETY339NCG44TV1
EUCALYPTUS OILINACTIVE INGREDIENT2R04ONI6621
GLYCERININACTIVE INGREDIENTPDC6A3C0OX1
LIGHT MINERAL OILINACTIVE INGREDIENTN6K5787QVP1
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU41

Products#

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

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

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
37205-75137205-751-23

Ingredients#

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

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

Source Document#

Source XML

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 3 · 144 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
SILICON DIOXIDESILICON DIOXIDEETJ7Z6XBU4TABLET, DELAYED RELEASE / ORAL1190 mgExact identifier — unii candidate
49 equally ranked IID candidates
SILICON DIOXIDESILICON DIOXIDEETJ7Z6XBU4TABLET, COATED / ORAL176 mgExact identifier — unii candidate
49 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSOLUTION / ORAL32400 mgExact identifier — unii candidate
75 equally ranked IID candidates
LIGHT MINERAL OILLIGHT MINERAL OILN6K5787QVPTABLET / ORAL7.5 mgExact identifier — unii candidate
19 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSYSTEM / IONTOPHORESIS168.1 mgExact identifier — unii candidate
75 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSYSTEM / TOPICAL18144 mgExact identifier — unii candidate
75 equally ranked IID candidates
SILICON DIOXIDESILICON DIOXIDEETJ7Z6XBU4CAPSULE, COATED PELLETS / ORAL69 mgExact identifier — unii candidate
49 equally ranked IID candidates
SILICON DIOXIDESILICON DIOXIDEETJ7Z6XBU4POWDER, FOR SOLUTION / ORAL280 mgExact identifier — unii candidate
49 equally ranked IID candidates
SILICON DIOXIDESILICON DIOXIDEETJ7Z6XBU4PELLET / ORAL34 mgExact identifier — unii candidate
49 equally ranked IID candidates
LIGHT MINERAL OILLIGHT MINERAL OILN6K5787QVPGEL / TOPICAL20 mgExact identifier — unii candidate
19 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXINJECTION, SOLUTION / SUBCUTANEOUS15 %w/vExact identifier — unii candidate
75 equally ranked IID candidates
LIGHT MINERAL OILLIGHT MINERAL OILN6K5787QVPPASTILLE / ORAL3.6 mgExact identifier — unii candidate
19 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXDROPS / NASAL10 mg/1mlExact identifier — unii candidate
75 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSUSPENSION/ DROPS / OPHTHALMIC2.5 %w/vExact identifier — unii candidate
75 equally ranked IID candidates
SILICON DIOXIDESILICON DIOXIDEETJ7Z6XBU4TABLET, CHEWABLE, EXTENDED RELEASE / ORAL2 mgExact identifier — unii candidate
49 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSOLUTION / AURICULAR (OTIC)63.64 %w/vExact identifier — unii candidate
75 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXFILM, EXTENDED RELEASE / BUCCAL34 mgExact identifier — unii candidate
75 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXGEL / TRANSDERMAL500 mgExact identifier — unii candidate
75 equally ranked IID candidates
SILICON DIOXIDESILICON DIOXIDEETJ7Z6XBU4GRANULE, FOR SOLUTION / ORAL1.8 mg/120mlExact identifier — unii candidate
49 equally ranked IID candidates
SILICON DIOXIDESILICON DIOXIDEETJ7Z6XBU4SUPPOSITORY / RECTAL14 mgExact identifier — unii candidate
49 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSUPPOSITORY / VAGINAL227.9 mgExact identifier — unii candidate
75 equally ranked IID candidates
LIGHT MINERAL OILLIGHT MINERAL OILN6K5787QVPOINTMENT / TOPICAL1335 mgExact identifier — unii candidate
19 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSOLUTION / NASAL25 mg/1mlExact identifier — unii candidate
75 equally ranked IID candidates
SILICON DIOXIDESILICON DIOXIDEETJ7Z6XBU4CAPSULE, COATED, EXTENDED RELEASE / ORALNAExact identifier — unii candidate
49 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXINJECTION / INTRADERMAL1.6 %w/vExact identifier — unii candidate
75 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSUSPENSION, EXTENDED RELEASE / ORAL2000 mgExact identifier — unii candidate
75 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXJELLY / VAGINALNAExact identifier — unii candidate
75 equally ranked IID candidates
SILICON DIOXIDESILICON DIOXIDEETJ7Z6XBU4TABLET, ORALLY DISINTEGRATING / ORAL68 mgExact identifier — unii candidate
49 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXINJECTION / SUBCUTANEOUS450 mgExact identifier — unii candidate
75 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSOAP / TOPICAL0.76 %w/wExact identifier — unii candidate
75 equally ranked IID candidates
LIGHT MINERAL OILLIGHT MINERAL OILN6K5787QVPTABLET, EXTENDED RELEASE / ORAL1 mgExact identifier — unii candidate
19 equally ranked IID candidates
SILICON DIOXIDESILICON DIOXIDEETJ7Z6XBU4POWDER / ORAL602 mgExact identifier — unii candidate
49 equally ranked IID candidates
SILICON DIOXIDESILICON DIOXIDEETJ7Z6XBU4SOLUTION / ORAL336 mgExact identifier — unii candidate
49 equally ranked IID candidates
SILICON DIOXIDESILICON DIOXIDEETJ7Z6XBU4TABLET / BUCCAL3 mgExact identifier — unii candidate
49 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXCREAM, AUGMENTED / TOPICAL55 mgExact identifier — unii candidate
75 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSOLUTION / RESPIRATORY (INHALATION)5 %w/wExact identifier — unii candidate
75 equally ranked IID candidates
LIGHT MINERAL OILLIGHT MINERAL OILN6K5787QVPOIL / TOPICAL2509 mgExact identifier — unii candidate
19 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXINJECTION, SOLUTION / INTRAMUSCULAR15 %w/vExact identifier — unii candidate
75 equally ranked IID candidates
LIGHT MINERAL OILLIGHT MINERAL OILN6K5787QVPSUPPOSITORY / VAGINAL1464.9 mgExact identifier — unii candidate
19 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXDOUCHE / VAGINAL1 %w/wExact identifier — unii candidate
75 equally ranked IID candidates
SILICON DIOXIDESILICON DIOXIDEETJ7Z6XBU4GEL / DENTAL19 %w/wExact identifier — unii candidate
49 equally ranked IID candidates
SILICON DIOXIDESILICON DIOXIDEETJ7Z6XBU4POWDER / RESPIRATORY (INHALATION)NAExact identifier — unii candidate
49 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSUSPENSION / OPHTHALMIC58 mgExact identifier — unii candidate
75 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSOLUTION/ DROPS / AURICULAR (OTIC)25 mgExact identifier — unii candidate
75 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXFILM, EXTENDED RELEASE / TRANSDERMAL306.2 mgExact identifier — unii candidate
75 equally ranked IID candidates
SILICON DIOXIDESILICON DIOXIDEETJ7Z6XBU4GRANULE / ORAL5000 mgExact identifier — unii candidate
49 equally ranked IID candidates
SILICON DIOXIDESILICON DIOXIDEETJ7Z6XBU4TABLET, EXTENDED RELEASE / ORAL450 mgExact identifier — unii candidate
49 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXEMULSION / INTRAVENOUS2.2 %w/vExact identifier — unii candidate
75 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXGEL / OPHTHALMIC0.88 %w/wExact identifier — unii candidate
75 equally ranked IID candidates
LIGHT MINERAL OILLIGHT MINERAL OILN6K5787QVPCAPSULE / ORAL6 mgExact identifier — unii candidate
19 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSPONGE / TOPICAL2 %w/wExact identifier — unii candidate
75 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXCAPSULE / ORAL3487 mgExact identifier — unii candidate
75 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXJELLY / TOPICALNAExact identifier — unii candidate
75 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSOLUTION, CONCENTRATE / ORAL200 mg/1mlExact identifier — unii candidate
75 equally ranked IID candidates
LIGHT MINERAL OILLIGHT MINERAL OILN6K5787QVPCREAM / TOPICAL456 mgExact identifier — unii candidate
19 equally ranked IID candidates
SILICON DIOXIDESILICON DIOXIDEETJ7Z6XBU4TABLET, CHEWABLE / ORAL254 mgExact identifier — unii candidate
49 equally ranked IID candidates
LIGHT MINERAL OILLIGHT MINERAL OILN6K5787QVPSYSTEM / TRANSDERMAL170 mgExact identifier — unii candidate
19 equally ranked IID candidates
EUCALYPTUS OILEUCALYPTUS OIL2R04ONI662SYRUP / ORALNAExact identifier — unii candidate
GLYCERINGLYCERINPDC6A3C0OXSUSPENSION / ORAL26208 mgExact identifier — unii candidate
75 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSPRAY, METERED / NASAL13 mgExact identifier — unii candidate
75 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
0d56c799-2287-4d9e-83e3-d4232530fef37c55f702-e86e-4dd5-9624-e636fc1c15262025-04-23WarningsExact identifier
spl set id: 7c55f702-e86e-4dd5-9624-e636fc1c1526

Reported adverse events (FAERS/openFDA)#

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