72937-310-08

72937-310-08
SPL v9
SPL
SPL Set ID bcb8a65b-3b2f-b82f-e053-2a95a90a51af
Route
TOPICAL
Published
Effective Date 2024-06-04
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Menthol (10 g) Camphor (natural) (3 g)
Inactive Ingredients
Linalool, (+/-)- Limonene, (+)- Tributyl Citrate Panthenol Hydroxyproline Propylparaben Stearyl Alcohol Acrylic Acid/sodium Acrylate Copolymer (1:1; 600 Mpa.s At 0.2%) Glycereth-26 Diazolidinyl Urea Buteth-3 Fd&c Blue No. 1 Water Stearic Acid Glyceryl Stearate Se Methylparaben Cannabis Sativa Seed Oil Trideceth-6 Polysorbate 20 Sodium Benzotriazolyl Butylphenol Sulfonate Polysorbate 60 Cetyl Alcohol Dimethicone 1000 Alcohol Trolamine Cetostearyl Alcohol Hyaluronate Sodium Sodium Pyrrolidone Carboxylate Coumarin Cannabidiol Propylene Glycol .alpha.-tocopherol Acetate Amino Acids, Wheat Benzyl Benzoate Comfrey Geraniol Mineral Oil

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

Keep out of reach of children

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

Section 50566-9

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.

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

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 consult a doctor

Sunset Pain Relief Cream Tube 8 Fl Oz


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)

Keep out of reach of children

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

Section 50566-9 (50566-9)

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.

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)

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 consult a doctor

Sunset Pain Relief Cream Tube 8 Fl Oz (SUNSET PAIN RELIEF CREAM TUBE 8 FL OZ)


Advanced Ingredient Data


Raw Label Data

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