FDA.reportPublic FDA data

CAMPHOR

Manufacturer
EROS GLOBAL CORP | CHEMCO CORPORATION
Effective date
2022-07-07
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-05-31 23:50:11

Label at a glance#

ProductCAMPHOR
Active ingredientCAMPHOR (NATURAL)
Label structure8 sections

Label contents#

Full prescribing information#

DOSAGE & ADMINISTRATION SECTION

Apply to affected areas not more than 1-3 times daily.

WARNINGS SECTION

For external use only.
Avoid contact with eyes.
If you are breastfeeding, consult a health care practitioner prior to use.

INACTIVE INGREDIENT SECTION

Aqua, Caprylic/Capric Triglyceride, Paraffinum Liquidum, Glyceryl Stearate, PEG-100 Stearate, Dimethicone, Petrolatum, Cetyl Alcohol, Propylene Glycol, Diazolidinyl Urea, Methylparaben, Propylparaben, Triethanolamine, Thymus Vulgaris (Thyme) Oil, Stearyl Alcohol, Parfum, Carbomer, Canola Oil, Rosmarinus Officinalis (Rosemary) Oil, Citral, D-Limonene, Geraniol, Linalool.

INDICATIONS & USAGE SECTION

Helps relieve respiratory discomfort, cough, and congestion.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of the children.

OTC - PURPOSE SECTION

External Analgesic

OTC - ACTIVE INGREDIENT SECTION

Camphor……………………………………..………………….……... 0.15%

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

cream 4ozcream 4oz

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
2606065camphor 0.15 % Topical CreamPSN3
2606065camphor 1.5 MG/ML Topical CreamSCD3
2606065camphor 0.15 % Topical CreamSY3

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
80465-015-042024-01-30C16284748780-11030e365-021a-111a-e063-dadaa90a10e280465-015-04

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
80465-015-04CAMPHOR113 g in 1 BOTTLECREAM1133

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
80465-015CAMPHOR CREAM [EROS GLOBAL CORP]3Legacy NDC, 1 package rows20220716_b074cfc6-aa16-1136-e053-2995a90a2885.zip

Products#

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

DailyMed product names page 1 of 1 · 19 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
80465-01580465-015-04

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 18 matching rows.

Name, UNII, Kind table
NameUNIIKind
CAMPHOR (NATURAL)N20HL7Q941ACTIB
GLYCERYL STEARATE/PEG-100 STEARATERD25J5V947IACT
PROPYLPARABENZ8IX2SC1OHIACT
THYMUS VULGARIS LEAFGRX3499643IACT
ROSMARINUS OFFICINALIS FLOWERING TOP OILOXN0D3N28LIACT
CITRALT7EU0O9VPPIACT
LINALOOL, (+)-F4VNO44C09IACT
CETYL ALCOHOL936JST6JCNIACT
METHYLPARABENA2I8C7HI9TIACT
STEARYL ALCOHOL2KR89I4H1YIACT
CARBOMER 9404Q93RCW27EIACT
CANOLA OIL331KBJ17RKIACT
LIMONENE, (+/-)-9MC3I34447IACT
GERANIOLL837108USYIACT
WATER059QF0KO0RIACT
DIMETHICONE 1000MCU2324216IACT
DIAZOLIDINYL UREAH5RIZ3MPW4IACT
PETROLATUM4T6H12BN9UIACT

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
e33b3817-7527-0b69-e053-2995a90a95f6b074cfc6-aa16-1136-e053-2995a90a28852022-07-07WarningsExact identifier
spl id: e33b3817-7527-0b69-e053-2995a90a95f6
spl set id: b074cfc6-aa16-1136-e053-2995a90a2885

Reported adverse events (FAERS/openFDA)#

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