72937-103-04

72937-103-04
SPL v6
SPL
SPL Set ID b0edcf3d-0f58-54d8-e053-2995a90a9c49
Route
TOPICAL
Published
Effective Date 2020-10-05
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Menthol (10 g) Camphor (natural) (3 g)
Inactive Ingredients
Tributyl Citrate Panthenol Hydroxyproline Propylparaben Stearyl Alcohol Mineral Oil Buteth-3 Propylene Glycol Alcohol Acrylic Acid/sodium Acrylate Copolymer (1:1; 600 Mpa.s At 0.2%) Stearic Acid Glycereth-26 Diazolidinyl Urea Basic Blue 1 Water Trideceth-6 Glyceryl Stearate Se Methylparaben Cannabis Sativa Seed Oil Polysorbate 20 Sodium Benzotriazolyl Butylphenol Sulfonate Polysorbate 60 Cetyl Alcohol Dimethicone 1000 .alpha.-tocopherol Cannabidiol Hyaluronate Sodium Trolamine

Identifiers & Packaging

Pill Appearance
Color: green
Marketing Status
OTC MONOGRAPH DRUG Completed Since 2020-10-05 Until 2026-03-12

Description

Menthol 10% Camphor 3%


Medication Information

Warnings and Precautions

For external use only.

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.

Indications and Usage

For the temporary relief of minor aches and pains of muscles and joints associated with simple backache, arthritis, sprains and strains.

Dosage and Administration

Adults and children over 12 years of age; apply a thin layer to 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 unless directed by doctor/physician

Description

Menthol 10% Camphor 3%

Section 44425-7

Store at room temperature 15° - 30°C (59° - 86°F)

Section 50565-1

Keep away from children. Package not child resistant.

Section 50567-7

Avoid contact with eyes, mucous membranes, rashesm wounds or damaged skin.

Do nor apply on nose or genital area.

If rash, redness or itchiness results; discontinue use and consult a doctor.

Section 51727-6

Aqua, Paraffinum Liquidum, Alcohol Denat, Stearic Acid, Cetearyl Alcohol, Polysorbate 60, Cetyl Alcohol, Dimethicone, Glyceryl Stearate, Glycereth-26, Propylene Glycol, Diazolidinyl Urea, Methylparaben, Propylparaben, Tocopheryl Acetate, Cannabis Sativa Seed Oil, Stearyl Alcohol, Acrylamide/Sodium Acrylate Copolymer, Trideceth-6, Polysorbate 20, Triethanolamine, 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 #1 Powder (CI 42090), Linalool, Limonene, Benzyl Benzoate, Coumarin, Geraniol.

Section 51945-4

Section 55105-1

External Analgesic

Pain Relieving

Section 55106-9

Menthol 10%

Camphor 3%


Structured Label Content

Indications and Usage (34067-9)

For the temporary relief of minor aches and pains of muscles and joints associated with simple backache, arthritis, sprains and strains.

Dosage and Administration (34068-7)

Adults and children over 12 years of age; apply a thin layer to 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 unless directed by doctor/physician

Warnings and Precautions (34071-1)

For external use only.

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 44425-7 (44425-7)

Store at room temperature 15° - 30°C (59° - 86°F)

Section 50565-1 (50565-1)

Keep away from children. Package not child resistant.

Section 50567-7 (50567-7)

Avoid contact with eyes, mucous membranes, rashesm wounds or damaged skin.

Do nor apply on nose or genital area.

If rash, redness or itchiness results; discontinue use and consult a doctor.

Section 51727-6 (51727-6)

Aqua, Paraffinum Liquidum, Alcohol Denat, Stearic Acid, Cetearyl Alcohol, Polysorbate 60, Cetyl Alcohol, Dimethicone, Glyceryl Stearate, Glycereth-26, Propylene Glycol, Diazolidinyl Urea, Methylparaben, Propylparaben, Tocopheryl Acetate, Cannabis Sativa Seed Oil, Stearyl Alcohol, Acrylamide/Sodium Acrylate Copolymer, Trideceth-6, Polysorbate 20, Triethanolamine, 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 #1 Powder (CI 42090), Linalool, Limonene, Benzyl Benzoate, Coumarin, Geraniol.

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

External Analgesic

Pain Relieving

Section 55106-9 (55106-9)

Menthol 10%

Camphor 3%


Advanced Ingredient Data


Raw Label Data

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