72937-310-04

72937-310-04
SPL v6
SPL
SPL Set ID bcb887e3-1ea7-48f2-e053-2995a90a4be1
Route
TOPICAL
Published
Effective Date 2024-08-13
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Menthol (10 g) Camphor (natural) (3 g)
Inactive Ingredients
Trideceth-6 Glyceryl Stearate Se Methylparaben Cannabis Sativa Seed Oil Polysorbate 20 Sodium Benzotriazolyl Butylphenol Sulfonate Polysorbate 60 Cetyl Alcohol Dimethicone 1000 Tributyl Citrate Panthenol Hydroxyproline Propylparaben Stearyl Alcohol Acrylic Acid/sodium Acrylate Copolymer (1:1; 600 Mpa.s At 0.2%) Stearic Acid Glycereth-26 Diazolidinyl Urea Buteth-3 Basic Blue 1 Water

Identifiers & Packaging

Pill Appearance
Color: green
Marketing Status
OTC MONOGRAPH DRUG Completed Since 2021-03-04 Until 2026-08-05

Description

Camphor 3% Menthol 10%


Medication Information

Warnings and Precautions

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

Description

Camphor 3% Menthol 10%

Use

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

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.

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.

Section 51727-6

Water (Aqua), Paraffinum Liquidum, Alcohol Denat, Stearic Acid, Cetearyl Alcohol, Polysorbate 60, Cetyl Alcohol, Dimethicone, Glyceryl Stearate, Glycereth-26, Tocopheryl Acetate, Propylene Glycol, Diazolidinyl Urea, Methylparaben, Propylparaben, Cannabis Sativa Seed Oil, Stearyl Alcohol, Acrylamide/Sodium Acrylate Copolymer, Trideceth-6, Polysorbate 20, Triethanolamine, Fragrance (Parfum), Sodium Hyaluronate, Sodium PCA, Wheat Amino Acids, Panthenol, Symphytum Officinale (Comfrey) Extract, Hydroxyproline, Sodium Benzotriazolyl Butylphenol Sulfonate, Buteth-3, Tributyl Citrate, Cannabidiol, FD&C Blue No.1 (CI 42090), Linalool, Limonene, Benzyl Benzoate, Coumarin, Geraniol.

Section 53414-9

If pregnant or breast – feeding

Ask a health professional before use.

Section 55105-1

Topical Analgesic

Section 55106-9

Camphor 3%

Menthol 10%

Directions

Adults and Children over 12 years

Apply a thin layer to the affected area and rub gently not more than 3 to 4 times a day.

Wash hands with soap and water after use.

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

Other Information

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

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.

Sunset Pain Relief Cream 4 Fl Oz Tube


Structured Label Content

Use

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

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.

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.

Section 51727-6 (51727-6)

Water (Aqua), Paraffinum Liquidum, Alcohol Denat, Stearic Acid, Cetearyl Alcohol, Polysorbate 60, Cetyl Alcohol, Dimethicone, Glyceryl Stearate, Glycereth-26, Tocopheryl Acetate, Propylene Glycol, Diazolidinyl Urea, Methylparaben, Propylparaben, Cannabis Sativa Seed Oil, Stearyl Alcohol, Acrylamide/Sodium Acrylate Copolymer, Trideceth-6, Polysorbate 20, Triethanolamine, Fragrance (Parfum), Sodium Hyaluronate, Sodium PCA, Wheat Amino Acids, Panthenol, Symphytum Officinale (Comfrey) Extract, Hydroxyproline, Sodium Benzotriazolyl Butylphenol Sulfonate, Buteth-3, Tributyl Citrate, Cannabidiol, FD&C Blue No.1 (CI 42090), Linalool, Limonene, Benzyl Benzoate, Coumarin, Geraniol.

Section 53414-9 (53414-9)

If pregnant or breast – feeding

Ask a health professional before use.

Section 55105-1 (55105-1)

Topical Analgesic

Section 55106-9 (55106-9)

Camphor 3%

Menthol 10%

Directions

Adults and Children over 12 years

Apply a thin layer to the affected area and rub gently not more than 3 to 4 times a day.

Wash hands with soap and water after use.

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

Other Information

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

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.

Sunset Pain Relief Cream 4 Fl Oz Tube (SUNSET PAIN RELIEF CREAM 4 FL OZ TUBE)


Advanced Ingredient Data


Raw Label Data

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