72937-010-02

72937-010-02
SPL v22
SPL
SPL Set ID 89f5f688-856f-f2df-e053-2995a90a73cf
Route
TOPICAL
Published
Effective Date 2023-09-15
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Menthol, Unspecified Form (10 g) Camphor (natural) (3 g)
Inactive Ingredients
Panthenol Alcohol Polysorbate 60 Cetyl Alcohol Dimethicone 1000 .alpha.-tocopherol Acetate Linalool, (+/-)- Trideceth-6 Amino Acids, Wheat Benzyl Benzoate Hydroxyproline Glyceryl Monostearate Glycereth-26 Stearyl Alcohol Tributyl Citrate Geraniol Diazolidinyl Urea Trolamine Buteth-3 Sodium Benzotriazolyl Butylphenol Sulfonate Cetostearyl Alcohol Polysorbate 20 Hyaluronate Sodium Limonene, (+)- Fd&c Blue No. 1 Coumarin Cannabidiol Methylparaben Sodium Pyrrolidone Carboxylate Propylene Glycol Propylparaben Cannabis Sativa Seed Oil Symphytum Officinale Whole Stearic Acid Water Mineral Oil

Identifiers & Packaging

Pill Appearance
Color: blue
Marketing Status
OTC MONOGRAPH DRUG Completed Since 2019-05-24 Until 2027-06-25

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 50566-9

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

If pregnant or breast – feeding

Ask a health professional before use.

Section 55105-1

​Topical Analgesic

Section 55106-9

Camphor 3%

Menthol 10%

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 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.

Sunset Pain Relief Cream Gold 2 Oz

Sunset Pain Relief Cream Gold 4 Oz

Sunset Pain Relief Cream Gold 8 Oz

Sunset Pain Relief Cream Gold 16 Oz


Structured Label Content

Use (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 50566-9 (50566-9)

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)

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%

Section 60561-8 (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 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.

Sunset Pain Relief Cream Gold 2 Oz (SUNSET PAIN RELIEF CREAM GOLD 2 OZ)

Sunset Pain Relief Cream Gold 4 Oz (SUNSET PAIN RELIEF CREAM GOLD 4 OZ)

Sunset Pain Relief Cream Gold 8 Oz (SUNSET PAIN RELIEF CREAM GOLD 8 OZ)

Sunset Pain Relief Cream Gold 16 Oz (SUNSET PAIN RELIEF CREAM GOLD 16 OZ)


Advanced Ingredient Data


Raw Label Data

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