FDA.reportPublic FDA data

Major Camphor and Phenol

Manufacturer
Major Pharmaceuticals | Lee Pharmaceuticals
Effective date
2012-08-17
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
legacy-cache
Hydrated at
2026-08-02 01:46:26

Label at a glance#

ProductMajor Camphor and Phenol
Active ingredientCAMPHOR (SYNTHETIC), PHENOL
Label structure12 sections

Indications and uses

first aid to help reduce the risk of infection associated with minor cuts, scrapes, minor burns, and insect bites for the temporary relief of pain and itching associated with minor burns, sunbrun, minor cuts, scrapes, fever blisters and cold sores

Dosage and administration

clean the affected area adults and children 2 years of age or older: apply a small amount of this product on the area 1 to 3 times daily children under 2 years of age: consult a doctor

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Camphorated phenol

(camphor, 10.8% and phenol, 4.7%)

Purpose

OTC - PURPOSE SECTION

Pain reliever/antiseptic

USES

INDICATIONS & USAGE SECTION

  • first aid to help reduce the risk of infection associated with minor cuts, scrapes, minor burns, and insect bites
  • for the temporary relief of pain and itching associated with minor burns, sunbrun, minor cuts, scrapes, fever blisters and cold sores

Warnings

WARNINGS SECTION

  • for external use only

Do not use

OTC - DO NOT USE SECTION

  • in the eyes
  • or apply over large areas of the body

Ask a doctor before use if you have

OTC - ASK DOCTOR SECTION

  • deep or puncture wounds
  • animal bites
  • serious burns

When using this product

OTC - WHEN USING SECTION

  • avoid contact with the eyes
  • do not bandage

Stop use and ask 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

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

Directions

DOSAGE & ADMINISTRATION SECTION

  • clean the affected area
  • adults and children 2 years of age or older: apply a small amount of this product on the area 1 to 3 times daily
  • children under 2 years of age: consult a doctor

Inactive ingredients

INACTIVE INGREDIENT SECTION

eucalyptus oil, light mineral oil

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Major

Camphor & Phenol

Antiseptic Liquid

1.5 fl. oz (44ml)

label imageimage of labelimage of label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Major

Camphor & Phenol

Antiseptic Liquid

1.5 fl. oz (44ml)

carton imageimage of cartonimage of carton

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
00904-7851-62019-11-13C16284748780-197449f38-d3d6-f6ea-e053-dbdaa90aa703Drug Facts

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
CAMPHOR (SYNTHETIC)ACTIVE INGREDIENT5TJD82A1ET3
PHENOLACTIVE INGREDIENT339NCG44TV3
CAMPHOR (SYNTHETIC)ACTIVE MOIETY5TJD82A1ET3
PHENOLACTIVE MOIETY339NCG44TV3
EUCALYPTUS OILINACTIVE INGREDIENT2R04ONI6623
LIGHT MINERAL OILINACTIVE INGREDIENTN6K5787QVP3

Products#

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

DailyMed product names page 1 of 1 · 6 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
00904-785100904-7851-7, 00904-7851-6

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 4 matching rows.

Name, UNII, Kind table
NameUNIIKind
CAMPHOR (SYNTHETIC)5TJD82A1ETACTIM
PHENOL339NCG44TVACTIB
EUCALYPTUS OIL2R04ONI662IACT
LIGHT MINERAL OILN6K5787QVPIACT

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 1 · 20 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
LIGHT MINERAL OILLIGHT MINERAL OILN6K5787QVPTABLET, EXTENDED RELEASE / ORAL1 mgExact identifier — unii candidate
19 equally ranked IID candidates
LIGHT MINERAL OILLIGHT MINERAL OILN6K5787QVPTABLET, FILM COATED / ORAL2.49 mgExact identifier — unii candidate
19 equally ranked IID candidates
LIGHT MINERAL OILLIGHT MINERAL OILN6K5787QVPFILM, EXTENDED RELEASE / TRANSDERMAL162 mgExact identifier — unii candidate
19 equally ranked IID candidates
LIGHT MINERAL OILLIGHT MINERAL OILN6K5787QVPSUPPOSITORY / VAGINAL1464.9 mgExact identifier — unii candidate
19 equally ranked IID candidates
LIGHT MINERAL OILLIGHT MINERAL OILN6K5787QVPPASTE / DENTAL687 mgExact identifier — unii candidate
19 equally ranked IID candidates
LIGHT MINERAL OILLIGHT MINERAL OILN6K5787QVPOIL / TOPICAL2509 mgExact identifier — unii candidate
19 equally ranked IID candidates
LIGHT MINERAL OILLIGHT MINERAL OILN6K5787QVPAEROSOL, FOAM / TOPICAL240 mgExact identifier — unii candidate
19 equally ranked IID candidates
LIGHT MINERAL OILLIGHT MINERAL OILN6K5787QVPOINTMENT / TOPICAL1335 mgExact identifier — unii candidate
19 equally ranked IID candidates
LIGHT MINERAL OILLIGHT MINERAL OILN6K5787QVPLOTION / TOPICAL48000 mgExact identifier — unii candidate
19 equally ranked IID candidates
LIGHT MINERAL OILLIGHT MINERAL OILN6K5787QVPTABLET, COATED / ORAL4.8 mgExact identifier — unii candidate
19 equally ranked IID candidates
EUCALYPTUS OILEUCALYPTUS OIL2R04ONI662SYRUP / ORALNAExact identifier — unii candidate
LIGHT MINERAL OILLIGHT MINERAL OILN6K5787QVPSYSTEM / TRANSDERMAL170 mgExact identifier — unii candidate
19 equally ranked IID candidates
LIGHT MINERAL OILLIGHT MINERAL OILN6K5787QVPTABLET / ORAL7.5 mgExact identifier — unii candidate
19 equally ranked IID candidates
LIGHT MINERAL OILLIGHT MINERAL OILN6K5787QVPCAPSULE / ORAL6 mgExact identifier — unii candidate
19 equally ranked IID candidates
LIGHT MINERAL OILLIGHT MINERAL OILN6K5787QVPGEL / TOPICAL20 mgExact identifier — unii candidate
19 equally ranked IID candidates
LIGHT MINERAL OILLIGHT MINERAL OILN6K5787QVPCREAM, AUGMENTED / TOPICAL25 %w/wExact identifier — unii candidate
19 equally ranked IID candidates
LIGHT MINERAL OILLIGHT MINERAL OILN6K5787QVPOIL / AURICULAR (OTIC)419 mgExact identifier — unii candidate
19 equally ranked IID candidates
LIGHT MINERAL OILLIGHT MINERAL OILN6K5787QVPEMULSION / TOPICAL68100 mgExact identifier — unii candidate
19 equally ranked IID candidates
LIGHT MINERAL OILLIGHT MINERAL OILN6K5787QVPCREAM / TOPICAL456 mgExact identifier — unii candidate
19 equally ranked IID candidates
LIGHT MINERAL OILLIGHT MINERAL OILN6K5787QVPPASTILLE / ORAL3.6 mgExact identifier — unii candidate
19 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
1daa463f-7e91-47cb-a16d-7a95ca295b2e9282885f-b364-439b-b91b-7fcf4f7341212012-08-17WarningsExact identifier
spl id: 1daa463f-7e91-47cb-a16d-7a95ca295b2e
spl set id: 9282885f-b364-439b-b91b-7fcf4f734121

Reported adverse events (FAERS/openFDA)#

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