MENTHOL, CAMPHOR

Manufacturer
SUNSET NOVELTIES, INC
Effective date
2025-11-20
Label type
HUMAN OTC DRUG LABEL
Version
6
Source
full-release
Hydrated at
2026-06-01 01:17:38

Label at a glance#

ProductMENTHOL, CAMPHOR
Active ingredientMENTHOL, CAMPHOR, (-)-
Label structure15 sections

Indications and uses

Aid for temporary local relief of minor pain in muscles or joints.

Dosage and administration

Adults and Children over 12 years • Apply a small amount on the affected area.• Massage in circular motion, let set for a few seconds.• Repeat as necessary, but no more than 3 to 4 times daily. • Wash hands with soap and water after use. Children under 12 years of age consult a doctor

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Camphor 2%

Menthol 6%

OTC - PURPOSE SECTION

Topical Analgesic

USES:

INDICATIONS & USAGE SECTION

Aid for temporary local relief of minor pain in muscles or joints.

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 or use with a heating pad
Avoid contact with eyes and mucous membranes
Do not apply to wounds or damaged, broken, or irritated skin
A transient burning sensation or redness may occur upon application but generally disappears in several days
If you experience an allergic reaction, discontinue use, and consult a physician

Do not expose the area treated with product to heat or direct sunlight.

STOP USE AND ASK A DOCTOR IF:

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.

IF PREGNANT OR BREAST – FEEDING:

OTC - PREGNANCY OR BREAST FEEDING SECTION

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 the affected area.• Massage in circular motion, let set for a
few seconds.• Repeat as necessary, but no more than 3 to 4 times daily. • Wash hands
with soap and water after use.
Children under 12 years of age 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), Alcohol Denat, Propylene Glycol, Polysorbate 20, Carbomer, Sodium Hydroxide, Salicylic Acid, Glycerin, Mentha Piperita (Peppermint) Oil, Rosmarinus Officinalis (Rosemary) Oil, Thymus Vulgaris (Thyme) Oil, Melaleuca Alternifolia (Tea Tree) Leaf Oil, Cannabis Sativa Seed Oil, Benzyl Alcohol, Sorbic Acid, Cannabidiol, FD&C Blue No. 1 (CI 42090), FD&C Yellow No.5 (CI 19140).

SUNSET - COOLING PAIN RELIEF GEL 2oz

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

SUNSET COOLING PAIN RELIEF 2SUNSET COOLING PAIN RELIEF 2

SUNSET - COOLING PAIN RELIEF GEL 4oz

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

SUNSET COOLING PAIN RELIEF 4SUNSET COOLING PAIN RELIEF 4

SUNSET - COOLING PAIN RELIEF GEL 8oz

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

SUNSET COOLING PAIN RELIEF 8SUNSET COOLING PAIN RELIEF 8

SUNSET - COOLING PAIN RELIEF GEL 16oz

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

SUNSET COOLING PAIN RELIEF 16SUNSET COOLING PAIN RELIEF 16

Product Linked Resources#

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
4d7a96d5-8256-4268-9a6c-25ea66d321feProduct name120180814

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
72937-006-02MENTHOL, CAMPHOR59 g in 1 BOTTLEGEL596
72937-006-04MENTHOL, CAMPHOR118 g in 1 BOTTLEGEL1186
72937-006-08MENTHOL, CAMPHOR236 g in 1 BOTTLEGEL2366
72937-006-16MENTHOL, CAMPHOR472 g in 1 BOTTLEGEL4726

Products#

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

DailyMed product names page 1 of 1 · 21 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
72937-00672937-006-02, 72937-006-04, 72937-006-08, 72937-006-16

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 20 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, CAMPHORSUNSET NOVELTIES, INCf03090fa-f7e6-f53a-e053-2a95a90aa8192025-11-20WarningsExact identifier
ndc (package): 72937-006-08
ndc (package): 72937-006-02
ndc (package): 72937-006-04
ndc (package): 72937-006-16
ndc (product): 72937-006
ndc11 (package): 72937000616
ndc11 (package): 72937000602
ndc11 (package): 72937000604
ndc11 (package): 72937000608
spl id: 44130c5e-f752-2432-e063-6394a90aa5ec
spl set id: f03090fa-f7e6-f53a-e053-2a95a90aa819

Reported adverse events (FAERS/openFDA)#

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