72937-180-02

72937-180-02
SPL v3
SPL
SPL Set ID 05dfbbb0-d648-eeba-e063-6394a90a1ec7
Route
TOPICAL
Published
Effective Date 2023-09-15
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Menthol (9.8 g) Salicylic Acid (17.6 g)
Inactive Ingredients
Glyceryl Monostearate Cetyl Alcohol Glycereth-26 Trideceth-6 Caprylyl Glycol Phenoxyethanol Comfrey Leaf Cannabidiol Water Hyaluronate Sodium Amino Acids, Wheat Panthenol Hydroxyproline Hexylene Glycol Stearic Acid Dimethicone 1000 Stearyl Alcohol Trolamine Sodium Pyrrolidone Carboxylate Mineral Oil Fd&c Yellow No. 6

Identifiers & Packaging

Pill Appearance
Color: orange
Marketing Status
OTC MONOGRAPH DRUG Completed Since 2023-09-15 Until 2026-07-02

Description

Menthol 10% Methyl Salicylate 18%


Medication Information

Warnings and Precautions

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

Description

Menthol 10% Methyl Salicylate 18%

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

If you experience an allergic reaction, discontinue use and consult a doctor.

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

Section 51727-6

Water (Aqua), Paraffinum Liquidum, Glyceryl Stearate, Stearic Acid, Cetyl Alcohol, Dimethicone, Glycereth-26, Acrylamide/Sodium Acrylate Copolymer, Trideceth-6, Caprylyl Glycol, Phenoxyethanol, Hexylene Glycol, Stearyl Alcohol, Triethanolamine, Sodium Hyaluronate, Sodium PCA, Wheat Amino Acids, Panthenol, Symphytum Officinale (Comfrey) Extract, Hydroxyproline, Cannabidiol, FD&C Yellow No.6 (CI 15985).

Section 55105-1

Topical Analgesic.

Section 55106-9

Menthol 10%

Methyl Salicylate 18%

Section 60561-8

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

Directions:

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

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 Heating Pain Relief Cream 2 Oz

Sunset Heating Pain Relief Cream 4 Oz

Sunset Heating Pain Relief Cream 8 Oz

Sunset Heating Pain Relief Cream 16 Oz


Structured Label Content

Use (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

If you experience an allergic reaction, discontinue use and consult a doctor.

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

Section 51727-6 (51727-6)

Water (Aqua), Paraffinum Liquidum, Glyceryl Stearate, Stearic Acid, Cetyl Alcohol, Dimethicone, Glycereth-26, Acrylamide/Sodium Acrylate Copolymer, Trideceth-6, Caprylyl Glycol, Phenoxyethanol, Hexylene Glycol, Stearyl Alcohol, Triethanolamine, Sodium Hyaluronate, Sodium PCA, Wheat Amino Acids, Panthenol, Symphytum Officinale (Comfrey) Extract, Hydroxyproline, Cannabidiol, FD&C Yellow No.6 (CI 15985).

Section 55105-1 (55105-1)

Topical Analgesic.

Section 55106-9 (55106-9)

Menthol 10%

Methyl Salicylate 18%

Section 60561-8 (60561-8)

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

Directions: (DIRECTIONS:)

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

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 Heating Pain Relief Cream 2 Oz (SUNSET - HEATING PAIN RELIEF CREAM 2 oz)

Sunset Heating Pain Relief Cream 4 Oz (SUNSET - HEATING PAIN RELIEF CREAM 4 oz)

Sunset Heating Pain Relief Cream 8 Oz (SUNSET - HEATING PAIN RELIEF CREAM 8 oz)

Sunset Heating Pain Relief Cream 16 Oz (SUNSET - HEATING PAIN RELIEF CREAM 16 oz)


Advanced Ingredient Data


Raw Label Data

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