FDA.reportPublic FDA data

Camphotrol

Manufacturer
PureTek Corporation
Effective date
2024-07-26
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-06-01 00:16:08

Label at a glance#

ProductCamphotrol
Active ingredientCAMPHOR (SYNTHETIC), MENTHOL
Label structure8 sections

Indications and uses

for the temporary relief of minor aches and pains of muscles and joints associated with simple backache, arthritis, strains, bruises and sprains, etc.

Dosage and administration

■ adults and children 12 years of age or older: using the roll-on applicator massage a liberal amount of gel directly on the affected area, not more than 3 to 4 times daily  ■ children under the age of 12: do not use, consult a doctor ■ use only as directed

Storage and handling

■ keep container tightly closed ■ store at 20° to 25°C (68° to 77°F)

Label contents#

Full prescribing information#

Active Ingredients (% by weight)

OTC - ACTIVE INGREDIENT SECTION

Camphor 4%

Menthol 10%

Purpose

OTC - PURPOSE SECTION

Analgesic (pain relief)

Uses

INDICATIONS & USAGE SECTION

for the temporary relief of minor aches and pains of muscles and joints associated with simple backache, arthritis, strains, bruises and sprains, etc.

Warnings

WARNINGS SECTION

For external use only

Do not use on

OTC - DO NOT USE SECTION

■ wounds ■ damaged skin

When using this product

OTC - WHEN USING SECTION

■ avoid getting into eyes or mucous membranes ■ do not bandage tightly

Stop use and ask a doctor if

OTC - STOP USE SECTION

■ excessive irritation of the skin develops ■ condition worsens
■ symptoms last more than 7 days or clear up and occur again within a few days

If pregnant or breast-feeding,

OTC - PREGNANCY OR BREAST FEEDING SECTION

ask a health professional before use.

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.

Directions

DOSAGE & ADMINISTRATION SECTION

■ adults and children 12 years of age or older: using the roll-on applicator massage a liberal amount of gel directly on the affected area, not more than 3 to 4 times daily 
■ children under the age of 12: do not use, consult a doctor ■ use only as directed

Other information

STORAGE AND HANDLING SECTION

■ keep container tightly closed ■ store at 20° to 25°C (68° to 77°F)

Inactive ingredients

INACTIVE INGREDIENT SECTION

Acrylates Copolymer, Alcohol Denat., Boswellia Serrata Extract, Chondroitin Sulfate, Eucalyptus Globulus Leaf Oil, Glucosamine Sulfate, Glycerin, Ilex Paraguariensis (Yerba Mate) Leaf Powder, Magnesium Chloride, Mentha Piperita (Peppermint) Oil, MSM (Methylsulfonylmethane), Propylene Glycol, Triethanolamine, Water.

Camphotrol®

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LabelLabel

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1039731camphor 4 % / menthol 10 % Topical GelPSN4
1039731camphor 0.04 MG/MG / menthol 0.1 MG/MG Topical GelSCD4
1039731camphor 4 % / menthol 10 % Topical GelSY4

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
6bd95106-a412-1dad-b9cc-4cb74bfb27ceProduct name220230315
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
290f523a-f9db-9774-b5a9-e1f908ac1782Product name120150828
c6b65c52-69c7-df49-550a-a50c137f6218Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
59088-488-07Camphotrol85 g in 1 BOTTLE, WITH APPLICATORGEL854

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
59088-488CAMPHOTROL (CAMPHOR, MENTHOL) GEL [PURETEK CORPORATION]4Current NDC, Legacy NDC, 1 package rows20240727_ccac9f37-a374-4765-e053-2a95a90ad2f7.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
59088-488-07GM - Gram59088-48871bd6cbd-b404-4d1d-809e-cc516aa41b7e12022-02-07

Products#

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

DailyMed product names page 1 of 1 · 18 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
59088-48859088-488-07

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 16 matching rows.

Name, UNII, Kind table
NameUNIIKind
METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (4500 MPA.S)T967IEU43CIACT
ALCOHOL3K9958V90MIACT
INDIAN FRANKINCENSE4PW41QCO2MIACT
CHONDROITIN SULFATE (BOVINE)6IC1M3OG5ZIACT
EUCALYPTUS OIL2R04ONI662IACT
GLUCOSAMINE SULFATE1FW7WLR731IACT
GLYCERINPDC6A3C0OXIACT
ILEX PARAGUARIENSIS LEAF1Q953B4O4FIACT
MAGNESIUM CHLORIDE02F3473H9OIACT
PEPPERMINT OILAV092KU4JHIACT
DIMETHYL SULFONE9H4PO4Z4FTIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
TROLAMINE9O3K93S3TKIACT
WATER059QF0KO0RIACT
CAMPHOR (SYNTHETIC)5TJD82A1ETACTIB
MENTHOLL7T10EIP3AACTIB

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
CamphotrolCAMPHOR, MENTHOLPureTek Corporationccac9f37-a374-4765-e053-2a95a90ad2f72024-07-26WarningsExact identifier
ndc (package): 59088-488-07
ndc (product): 59088-488
ndc11 (package): 59088048807
spl id: 1e2d2f1a-8848-6a76-e063-6394a90ae170
spl set id: ccac9f37-a374-4765-e053-2a95a90ad2f7

Reported adverse events (FAERS/openFDA)#

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