73647-103-04

73647-103-04
SPL v5
SPL
SPL Set ID 0abece07-976c-4881-e063-6294a90a5c1b
Route
TOPICAL
Published
Effective Date 2024-09-13
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Menthol, Unspecified Form (10 g) Camphor (synthetic) (3 g)
Inactive Ingredients
Propylene Glycol Linalool, (+/-)- Water Mineral Oil Cetostearyl Alcohol Propylparaben Cannabidiol Trolamine Stearic Acid Glyceryl Stearate Se Glycereth-26 Diazolidinyl Urea Methylparaben Trideceth-6 Geraniol Coumarin Comfrey Leaf Buteth-3 Amino Acids, Wheat Cetyl Alcohol .alpha.-tocopherol Acetate Sodium Pyrrolidone Carboxylate Hydroxyproline Tributyl Citrate Dimethicone 1000 Polysorbate 60 Stearyl Alcohol Polysorbate 20 Hyaluronate Sodium Alcohol Sodium Benzotriazolyl Butylphenol Sulfonate Panthenol Limonene, (+)- Benzyl Benzoate

Identifiers & Packaging

Pill Appearance
Color: white
Marketing Status
OTC MONOGRAPH DRUG Completed Since 2023-12-20 Until 2026-12-24

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, Cetearyl Alcohol, Cetyl Alcohol, Stearic Acid, Dimethicone, Glyceryl Stearate, Glycereth-26, Tocopheryl Acetate, Propylene Glycol, Polysorbate 60, Diazolidinyl Urea, Methylparaben, Propylparaben, Acrylamide/Sodium Acrylate Copolymer, Trideceth-6, Stearyl Alcohol, 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, Limonene, Linalool, 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 tighly closed in a dry place at controlled room temperature between 59°-86° F (15°-30° C).

This product is intended only for use by healthy adults aged 21 years & older.

Directions

Adults over 21 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.

Just Cbd Soothing Cream With Menthol 4 Fl Oz

Just Cbd Soothing Cream With Menthol 8 Fl 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, Cetearyl Alcohol, Cetyl Alcohol, Stearic Acid, Dimethicone, Glyceryl Stearate, Glycereth-26, Tocopheryl Acetate, Propylene Glycol, Polysorbate 60, Diazolidinyl Urea, Methylparaben, Propylparaben, Acrylamide/Sodium Acrylate Copolymer, Trideceth-6, Stearyl Alcohol, 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, Limonene, Linalool, 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 tighly closed in a dry place at controlled room temperature between 59°-86° F (15°-30° C).

This product is intended only for use by healthy adults aged 21 years & older.

Directions (DIRECTIONS)

Adults over 21 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.

Just Cbd Soothing Cream With Menthol 4 Fl Oz (JUST CBD SOOTHING CREAM WITH MENTHOL 4 FL OZ)

Just Cbd Soothing Cream With Menthol 8 Fl Oz (JUST CBD SOOTHING CREAM WITH MENTHOL 8 FL OZ)


Advanced Ingredient Data


Raw Label Data

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