72937-300-40

72937-300-40
SPL v4
SPL
SPL Set ID fc8a8f20-97ab-481e-e053-6394a90a3525
Route
TOPICAL
Published
Effective Date 2023-06-26
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
Cannabidiol Propylene Glycol .alpha.-amylcinnamaldehyde .alpha.-hexylcinnamaldehyde Water Mineral Oil Cetostearyl Alcohol Propylparaben Trolamine Linalool, (+/-)- Stearic Acid Glyceryl Stearate Se Glycereth-26 Diazolidinyl Urea Methylparaben Cannabis Sativa Seed Oil Trideceth-6 Tea Tree Oil Geraniol Hydroxycitronellal Coumarin Comfrey Leaf Buteth-3 Amino Acids, Wheat Cetyl Alcohol .alpha.-tocopherol Acetate Sodium Pyrrolidone Carboxylate Hydroxyproline Glycerin Tributyl Citrate Aloe Vera Leaf Dimethicone 1000 Polysorbate 60 Stearyl Alcohol Polysorbate 20 Hyaluronate Sodium Alcohol Fd&c Yellow No. 5 Sodium Benzotriazolyl Butylphenol Sulfonate Panthenol

Identifiers & Packaging

Pill Appearance
Color: yellow
Marketing Status
OTC MONOGRAPH DRUG Completed Since 2020-02-04 Until 2026-12-21

Description

Menthol 10% 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 10% Camphor 3%

Uses:

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, Cetearyl Alcohol, Cetyl Alcohol, Stearic Acid, Dimethicone, Glyceryl Stearate, Glycereth-26, Tocopheryl Acetate, Cannabis Sativa Seed Oil, Propylene Glycol, Polysorbate 60, Diazolidinyl Urea, Methylparaben, Propylparaben, Acrylamide/Sodium Acrylate Copolymer, Trideceth-6, Fragrance (Parfum), Stearyl Alcohol, Polysorbate 20, Triethanolamine, Melaleuca Alternifolia (Tea Tree) Leaf Oil, Sodium Hyaluronate, Sodium PCA, Wheat Amino Acids, Panthenol, Symphytum Officinale (Comfrey) Extract, Hydroxyproline, Aloe Barbadensis Leaf Extract, Glycerin, Sodium Benzotriazolyl Butylphenol Sulfonate, Buteth-3, Tributyl Citrate, Cannabidiol, FD&C Yellow No.5 (CI 19140), Geraniol, Hexyl Cinnamal, Amyl Cinnamal, Citronellol, Hydroxycitronellal, Linalool, Coumarin.

Section 53414-9

If pregnant or breast – feeding

Ask a health professional before use.

Section 55105-1

Topical Analgesic

Section 55106-9

Menthol 10%

Camphor 3%

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 desired area.

Massage in circular motions until absorbed.

Repeat as needed, but no more than 3 to 4 times per day.

Wash hands with soap and water after use.

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

Sunset Joint and Muscle Pain Relief Cream Sachet

Sunset Joint and Muscle Pain Relief Cream 4 Oz Tube

Sunset Joint and Muscle Pain Relief Cream 8 Oz Tube


Structured Label Content

Uses: (USES:)

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, Cetearyl Alcohol, Cetyl Alcohol, Stearic Acid, Dimethicone, Glyceryl Stearate, Glycereth-26, Tocopheryl Acetate, Cannabis Sativa Seed Oil, Propylene Glycol, Polysorbate 60, Diazolidinyl Urea, Methylparaben, Propylparaben, Acrylamide/Sodium Acrylate Copolymer, Trideceth-6, Fragrance (Parfum), Stearyl Alcohol, Polysorbate 20, Triethanolamine, Melaleuca Alternifolia (Tea Tree) Leaf Oil, Sodium Hyaluronate, Sodium PCA, Wheat Amino Acids, Panthenol, Symphytum Officinale (Comfrey) Extract, Hydroxyproline, Aloe Barbadensis Leaf Extract, Glycerin, Sodium Benzotriazolyl Butylphenol Sulfonate, Buteth-3, Tributyl Citrate, Cannabidiol, FD&C Yellow No.5 (CI 19140), Geraniol, Hexyl Cinnamal, Amyl Cinnamal, Citronellol, Hydroxycitronellal, Linalool, Coumarin.

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)

Menthol 10%

Camphor 3%

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 desired area.

Massage in circular motions until absorbed.

Repeat as needed, but no more than 3 to 4 times per day.

Wash hands with soap and water after use.

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

Sunset Joint and Muscle Pain Relief Cream Sachet (SUNSET - JOINT AND MUSCLE PAIN RELIEF CREAM SACHET)

Sunset Joint and Muscle Pain Relief Cream 4 Oz Tube (SUNSET - JOINT AND MUSCLE PAIN RELIEF CREAM 4 oz TUBE)

Sunset Joint and Muscle Pain Relief Cream 8 Oz Tube (SUNSET - JOINT AND MUSCLE PAIN RELIEF CREAM 8 oz TUBE)


Advanced Ingredient Data


Raw Label Data

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