72937-630-40

72937-630-40
SPL v2
SPL
SPL Set ID 3a9019b1-8798-1ef9-e063-6394a90a09a4
Route
TOPICAL
Published
Effective Date 2025-10-01
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Menthol (6 g) Camphor (synthetic) (3 g)
Inactive Ingredients
Propylene Glycol Mentha Piperita (peppermint) Oil Fd&c Yellow No. 5 Carbomer 940 Glycerin Salicylic Acid Fd&c Blue No. 1 Polysorbate 20 Rosemary Oil Sorbic Acid Water Benzyl Alcohol Sodium Hydroxide Thymus Vulgaris (thyme) Oil Melaleuca Alternifolia (tea Tree) Leaf Oil Cannabis Sativa Seed Oil Alcohol

Identifiers & Packaging

Pill Appearance
Color: turquoise
Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-10-01

Description

Menthol 6% Camphor 3%


Medication Information

Warnings and Precautions
  • For external use only.
  • Ask a doctor before use if you have redness over affected area

Description

Menthol 6% Camphor 3%

Use

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

Section 50565-1

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

Section 50567-7
  • 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.
Section 51727-6

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 (Hemp) Seed Oil, Benzyl Alcohol, Sorbic Acid, FD&C Blue No. 1 (CI 42090), FD&C Yellow No.5 (CI 19140).

Section 55105-1

Topical Analgesic

Section 55106-9

Menthol 6%

Camphor 3%

Directions

Adults and children over 12 years

  • Apply a small amount on the affected area.
  • Massage in a circular motion until absorbed, let set for a few seconds.
  • Repeat as needed, but no more than 3 to 4 times per day.
  • Store tightly closed in a dry place at controlled room temperature between 59°-86° F (15°-30° C).
  • Wash hands with soap and water after use.

Children under 12 years of age consult a doctor.

Stop Use and Ask A Doctor If
  • 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

Ask a health professional before use.

Sunset Cooling Pain Relief Gel 4 Fl Oz Tube

Sunset Cooling Pain Relief Gel 8 Fl Oz Tube


Structured Label Content

Use

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

Warnings and Precautions (34071-1)
  • For external use only.
  • Ask a doctor before use if you have redness over affected area

Section 50565-1 (50565-1)

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

Section 50567-7 (50567-7)
  • 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.
Section 51727-6 (51727-6)

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 (Hemp) Seed Oil, Benzyl Alcohol, Sorbic Acid, FD&C Blue No. 1 (CI 42090), FD&C Yellow No.5 (CI 19140).

Section 55105-1 (55105-1)

Topical Analgesic

Section 55106-9 (55106-9)

Menthol 6%

Camphor 3%

Directions

Adults and children over 12 years

  • Apply a small amount on the affected area.
  • Massage in a circular motion until absorbed, let set for a few seconds.
  • Repeat as needed, but no more than 3 to 4 times per day.
  • Store tightly closed in a dry place at controlled room temperature between 59°-86° F (15°-30° C).
  • Wash hands with soap and water after use.

Children under 12 years of age consult a doctor.

Stop Use and Ask A Doctor If (Stop use and ask a doctor if)
  • 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 (If pregnant or breast-feeding)

Ask a health professional before use.

Sunset Cooling Pain Relief Gel 4 Fl Oz Tube (SUNSET - COOLING PAIN RELIEF GEL 4 Fl oz TUBE)

Sunset Cooling Pain Relief Gel 8 Fl Oz Tube (SUNSET - COOLING PAIN RELIEF GEL 8 Fl oz TUBE)


Advanced Ingredient Data


Raw Label Data

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