SUNSET COOLING PAIN RELIEF

Manufacturer
SUNSET NOVELTIES, INC
Effective date
2024-04-05
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
legacy-cache
Hydrated at
2026-08-01 21:05:52

Label at a glance#

ProductSUNSET COOLING PAIN RELIEF
Active ingredientMENTHOL, CAMPHOR (SYNTHETIC)
Label structure12 sections

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: do not use, consult a doctor.

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Camphor 2%

Menthol 6%

OTC - PURPOSE SECTION

Topical Analgesic

USE

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: 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), Alcohol Denat, Propylene Glycol, Polysorbate 20, Carbomer, Sodium Hydroxide, Mentha Piperita (Peppermint) Oil, Rosmarinus Officinalis (Rosemary) Oil, Thymus Vulgaris (Thyme) Oil, Melaleuca Alternifolia (Tea Tree) Leaf Oil, Cannabis Sativa Seed Oil, Polyacrylamide, C13-14 Isoparaffin, Laureth-7, Salicylic Acid, Glycerin, Benzyl Alcohol, Sorbic Acid, Cannabidiol, FD&C Blue No. 1 (CI 42090), FD&C Yellow No. 5 (CI 19140).

SUNSET - COOLING PAIN RELIEF GEL 8oz

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

COOLING CREAMCOOLING CREAM

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72937-260SUNSET COOLING PAIN RELIEF (MENTHOL, CAMPHOR) CREAM [SUNSET NOVELTIES, INC]1Unmatched20240415_155fe0ac-3306-0332-e063-6294a90ae8c2.zip

Products#

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

DailyMed product names page 1 of 1 · 25 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
72937-26072937-260-08

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 23 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
44139a86-fff3-baff-e063-6394a90a00b8155fe0ac-3306-0332-e063-6294a90ae8c22025-11-20WarningsExact identifier
spl set id: 155fe0ac-3306-0332-e063-6294a90ae8c2

Reported adverse events (FAERS/openFDA)#

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