FDA.reportPublic FDA data

MENTHOL, CAMPHOR

Manufacturer
SUNSET NOVELTIES, INC
Effective date
2025-11-20
Label type
HUMAN OTC DRUG LABEL
Version
11
Source
monthly-update
Hydrated at
2026-06-03 17:40:32

Label at a glance#

ProductMENTHOL, CAMPHOR
Active ingredientMENTHOL, UNSPECIFIED FORM, CAMPHOR (NATURAL)
Label structure15 sections

Indications and uses

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

Dosage and administration

Adults and Children over 12 years Apply a small amount on desired area. Massage in circular motions until absorbed. Repeat as needed, but no more than 3 to 4 times per day. Wash hands with soap and water after use. Children under 12 years of age: do not use, consult a doctor.

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Camphor 3%

Menthol 10%

OTC - PURPOSE SECTION

Topical Analgesic

USES:

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

OTC - WHEN USING SECTION

Use only as directed.
Do not bandage tightly.
Do not use with heating pad, pack, wrap, hot water bottle or any heating element.
In case of accidental ingestion, contact doctor immediately.

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

OTC - STOP USE SECTION

Condition worsens.
Redness is present.
Irritation develops.
Symptoms persist for more than 7 days or clear up occur again within a few days.

You experience signs injury, such as pain, swelling or blistering where the product was applied.

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

If swallowed, get medical help, or contact a Poison Control Center right away.

DIRECTIONS:

DOSAGE & ADMINISTRATION SECTION

Adults and Children over 12 years

Apply a small amount on desired area.
Massage in circular motions until absorbed.
Repeat as needed, but no more than 3 to 4 times per day.
Wash hands with soap and water after use.

Children under 12 years of age: do not use, consult a doctor.

OTHER SAFETY INFORMATION

Store tightly closed in a dry place at controlled room temperature between 59°-86° F (15°-30° C).

INACTIVE INGREDIENT SECTION

Water (Aqua), Paraffinum Liquidum, Alcohol Denat, Cetearyl Alcohol, Cetyl Alcohol, Stearic Acid, Dimethicone, Glyceryl Stearate, Glycereth-26, Tocopheryl Acetate, Cannabis Sativa Seed Oil, Propylene Glycol, Polysorbate 60, Diazolidinyl Urea, Methylparaben, Propylparaben, Acrylamide/Sodium Acrylate Copolymer, Trideceth-6, Fragrance (Parfum), Stearyl Alcohol, Polysorbate 20, Triethanolamine, Melaleuca Alternifolia (Tea Tree) Leaf Oil, Sodium Hyaluronate, Sodium PCA, Wheat Amino Acids, Panthenol, Symphytum Officinale (Comfrey) Extract, Hydroxyproline, Aloe Barbadensis Leaf Extract, Glycerin, Sodium Benzotriazolyl Butylphenol Sulfonate, Buteth-3, Tributyl Citrate, Cannabidiol, FD&C Yellow No.5 (CI 19140), Geraniol, Hexyl Cinnamal, Amyl Cinnamal, Citronellol, Hydroxycitronellal, Linalool, Coumarin.

SUNSET - JOINT AND MUSCLE PAIN RELIEF CREAM 2 oz

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

tea tree2tea tree2

SUNSET - JOINT AND MUSCLE PAIN RELIEF CREAM 4 oz

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

green tea 4green tea 4

SUNSET - JOINT AND MUSCLE PAIN RELIEF CREAM 8 oz

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

green tea 8green tea 8

SUNSET - JOINT AND MUSCLE PAIN RELIEF CREAM 16 oz

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

green tea 16green tea 16

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
QR code linkQR Codedrive.google.com/drive/folders/19-lS6ZOzy9FEi2oVr1ieEMZTeOvOEHyv?usp=sharingFD-03100 SUNSET - PAIN RELIEF CREAM TEA TREE-ALOE JAR 16oz 72937-300-16.jpg
QR code linkQR Codedrive.google.com/drive/folders/1yJo2WjxbcPNkOcTvtqJTvif6INx8-HJeFD-03100 SUNSET - PAIN RELIEF CREAM TEA TREE-ALOE JAR 2oz 72937-300-02.jpg
QR code linkQR Codedrive.google.com/open?id=1g3ImP0AHWgbAupi_rYSBwL7UtidFMVe6FD-03100 SUNSET - PAIN RELIEF CREAM TEA TREE-ALOE JAR 4oz 72937-300-04.jpg, FD-03100 SUNSET - PAIN RELIEF CREAM TEA TREE-ALOE JAR 8oz 72937-300-08.jpg

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
72937-300-082022-12-19C16284748780-1d6a99b39-d3d0-a426-e053-dadaa90af4c272937-300-02 72937-300-04 72937-300-08 72937-300-16

Products#

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

DailyMed product names page 1 of 2 · 42 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
72937-30072937-300-16, 72937-300-02, 72937-300-04, 72937-300-08

Ingredients#

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

DailyMed ingredient rows page 1 of 2 · 41 matching rows.

Name, UNII, Kind table
NameUNIIKind
.ALPHA.-HEXYLCINNAMALDEHYDE7X6O37OK2IIACT
.ALPHA.-AMYLCINNAMALDEHYDEWC51CA3418IACT
PROPYLENE GLYCOL6DC9Q167V3IACT
WATER059QF0KO0RIACT
MINERAL OILT5L8T28FGPIACT
CETOSTEARYL ALCOHOL2DMT128M1SIACT
PROPYLPARABENZ8IX2SC1OHIACT
TROLAMINE9O3K93S3TKIACT
LINALOOL, (+/-)-D81QY6I88EIACT
STEARIC ACID4ELV7Z65APIACT
GLYCERYL STEARATE SEFCZ5MH785IIACT
GLYCERETH-26NNE56F2N14IACT
DIAZOLIDINYL UREAH5RIZ3MPW4IACT
METHYLPARABENA2I8C7HI9TIACT
CANNABIS SATIVA SEED OIL69VJ1LPN1SIACT
TRIDECETH-63T5PCR2H0CIACT
TEA TREE OILVIF565UC2GIACT
GERANIOLL837108USYIACT
HYDROXYCITRONELLAL8SQ0VA4YURIACT
COUMARINA4VZ22K1WTIACT
COMFREY LEAFDG4F8T839XIACT
BUTETH-3OC116GRO69IACT
AMINO ACIDS, WHEAT0370GZL32FIACT
CETYL ALCOHOL936JST6JCNIACT
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0IACT
SODIUM PYRROLIDONE CARBOXYLATE469OTG57A2IACT
HYDROXYPROLINERMB44WO89XIACT
GLYCERINPDC6A3C0OXIACT
TRIBUTYL CITRATE827D5B1B6SIACT
ALOE VERA LEAFZY81Z83H0XIACT
DIMETHICONE 1000MCU2324216IACT
POLYSORBATE 60CAL22UVI4MIACT
STEARYL ALCOHOL2KR89I4H1YIACT
POLYSORBATE 207T1F30V5YHIACT
HYALURONATE SODIUMYSE9PPT4THIACT
ALCOHOL3K9958V90MIACT
FD&C YELLOW NO. 5I753WB2F1MIACT
SODIUM BENZOTRIAZOLYL BUTYLPHENOL SULFONATE0LA2QC9O3ZIACT
MENTHOL, UNSPECIFIED FORML7T10EIP3AACTIB
PANTHENOLWV9CM0O67ZIACT

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 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
4413e2ee-921b-fa2b-e063-6394a90a57249dafd0ca-d81e-7d86-e053-2a95a90a36442025-11-20WarningsExact identifier
spl id: 4413e2ee-921b-fa2b-e063-6394a90a5724
spl set id: 9dafd0ca-d81e-7d86-e053-2a95a90a3644
MENTHOL, CAMPHORMENTHOL, CAMPHORSUNSET NOVELTIES, INCfc8a8f20-97ab-481e-e053-6394a90a35252025-11-20WarningsExact identifier
ndc (product): 72937-300

Reported adverse events (FAERS/openFDA)#

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