MENTHOL, CAMPHOR

Manufacturer
EROS GLOBAL | CHEMCO CORPORATION
Effective date
2024-03-12
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-06-01 00:10:03

Label at a glance#

ProductMENTHOL, CAMPHOR
Active ingredientMENTHOL, CAMPHOR (NATURAL)
Label structure12 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Menthol 3%

Camphor 3%

OTC - PURPOSE SECTION

External Analgesic

INDICATIONS & USAGE SECTION

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

WARNINGS SECTION

For external use only.
Use only as directed.
Do not bandage tightly.
Do not use with heating pad, pack, wrap, hot water bottle or any heating element.

If prone to allergic reaction to the product, consult to a doctor before using.

OTC - ASK DOCTOR SECTION

Ask a doctor before use if you have redness over affected area.

OTC - WHEN USING SECTION

Avoid contact with eyes, mucous membranes, rashes.
Do not apply to wounds or damaged skin.
If condition worsens, or if symptoms persist for more than 7 days or clear up and occur again within a few days, discontinue use of this product, and consult a doctor.

If rash, redness or itchiness results; discontinue use and consult a doctor.

OTC - PREGNANCY OR BREAST FEEDING SECTION

If pregnant or breast – feeding

Ask a health professional before use.

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

DOSAGE & ADMINISTRATION SECTION

Adults and children over 12 years of age

Apply a thin layer to the affected area and rub gently not more than 3 to 4 times a day.
Wash hands with soap and water after use.

Children under 12 years of age; do not use unless directed by a doctor.

OTHER SAFETY INFORMATION

Store at room temperature 15° - 30°C (59° - 86°F)

INACTIVE INGREDIENT SECTION

Water (Aqua), Paraffinum Liquidum, Alcohol Denat, Cetyl Alcohol, Dimethicone, Glyceryl Stearate, Stearic Acid, Glycereth-26, Propylene Glycol, Stearyl Alcohol, Acrylamide/Sodium Acrylate Copolymer, Trideceth-6, Triethanolamine, Fragrance (Parfum), Sodium Hyaluronate, Sodium PCA, Wheat Amino Acids, Panthenol, Symphytum Officinale (Comfrey) Extract, Hydroxyproline, Diazolidinyl Urea, Methylparaben, Propylparaben, FD&C Blue No.1 (CI 42090), Linalool, Limonene, Benzyl Benzoate, Coumarin, Geraniol.

COOL RELIEF CREAM

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

cool relief creamcool relief cream

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
2606068camphor 3 % / menthol 3 % Topical CreamPSN4
2606068camphor 30 MG/ML / menthol 30 MG/ML Topical CreamSCD4
2606068camphor 3 % / menthol 3 % Topical CreamSY4

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
80465-003-04MENTHOL, CAMPHOR113 g in 1 BOTTLECREAM1134

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
80465-003MENTHOL, CAMPHOR CREAM [EROS GLOBAL]4Current NDC, Legacy NDC, 1 package rows20240321_b3495c95-ba4b-9459-e053-2a95a90a710f.zip

Products#

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

DailyMed product names page 1 of 1 · 30 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
80465-00380465-003-04

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 29 matching rows.

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
MENTHOL, CAMPHORMENTHOL, CAMPHOREROS GLOBALb3495c95-ba4b-9459-e053-2a95a90a710f2024-03-12WarningsExact identifier
ndc (package): 80465-003-04
ndc (product): 80465-003
ndc11 (package): 80465000304
spl id: 137c6781-8bba-de23-e063-6394a90a6abb
spl set id: b3495c95-ba4b-9459-e053-2a95a90a710f

Reported adverse events (FAERS/openFDA)#

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