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.

Active Ingredient

Camphor 3%

Menthol 10%

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.

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 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.

Just Cbd Soothing Cream With Menthol 4 Fl Oz

Just Cbd Soothing Cream With Menthol 8 Fl Oz


Structured Label Content

Warnings and Precautions (34071-1)

For external use only.

Ask a doctor before use if you have redness over affected area.

Active Ingredient (55106-9)

Camphor 3%

Menthol 10%

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.

Use (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 (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 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.

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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