70947-031-02

70947-031-02
SPL v3
SPL
SPL Set ID fa179dd0-200f-089c-e053-6294a90a8133
Route
TOPICAL
Published
Effective Date 2023-11-02
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
Stearyl Alcohol Sodium Pyrrolidone Carboxylate Fd&c Yellow No. 5 Buteth-3 Panthenol Diazolidinyl Urea Cannabidiol Hyaluronate Sodium Dimethicone 1000 Fd&c Blue No. 1 Hydroxyproline Amino Acids, Wheat Trideceth-6 Sodium Benzotriazolyl Butylphenol Sulfonate Cetostearyl Alcohol Glyceryl Stearate Se Alcohol Acrylamide Mineral Oil .alpha.-tocopherol Acetate, D- Caprylic/capric/lauric Triglyceride Polysorbate 20 Propylparaben Stearic Acid Water Cetyl Alcohol Glycereth-26 Methylparaben Tributyl Citrate Comfrey Propylene Glycol Polysorbate 60 Trolamine

Identifiers & Packaging

Pill Appearance
Color: green
Marketing Status
OTC MONOGRAPH DRUG Completed Since 2022-05-22 Until 2026-04-05

Description

Camphor 3% Menthol 10%


Medication Information

Warnings and Precautions

For external use only.

Use only as directed.

Do not bandage tightly.

Do not use with heating pad, pack, wrap, hot water bottle or any heating element.

Description

Camphor 3% Menthol 10%

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 50567-7

Avoid contact with eyes, mucous membranes, rashes.

Do not apply to wounds or damaged skin.

If condition worsens, or if symptoms persist for more than 7 days or clear up and occur again within a few days, discontinue use of this product, and consult a doctor.

Section 50569-3

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

Section 51727-6

Water (Aqua), Ethyl Alcohol, Paraffinum Liquidum, Cetearyl Alcohol, Cetyl Alcohol, Stearic Acid, Dimethicone, Glyceryl Stearate, Tocopheryl Acetate, Glycereth-26, Caprylic/Capric Triglyceride, Polysorbate 60, Acrylamide/Sodium Acrylate Copolymer, Trideceth-6, Propylene Glycol, Stearyl Alcohol, Polysorbate 20, Diazolidinyl Urea, Triethanolamine, Cannabidiol, Methylparaben, Propylparaben, Sodium Hyaluronate, Sodium PCA, Wheat Amino Acids, Panthenol, Symphytum Officinale (Comfrey) Extract, Hydroxyproline, Sodium Benzotriazolyl Butylphenol Sulfonate, Buteth-3, Tributyl Citrate, FD&C Blue No.1 (CI 42090), FD&C Yellow No.5 (CI 19140).

Section 53413-1

Contact us +1-305-468-8790

Section 53414-9

If pregnant or breast – feeding

Ask a health professional before use.

Section 55105-1

External Analgesic

Section 55106-9



Camphor 3%

Menthol 10%

Directions:

Adults and children over 12 years of age

Apply a thin layer to the affected area and rub gently not more than 3 to 4 times daily.

Wash hands with soap and water after use.

Children under 12 years of age; do not use unless directed by doctor.

Other Information:

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

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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.

Use only as directed.

Do not bandage tightly.

Do not use with heating pad, pack, wrap, hot water bottle or any heating element.

Section 50565-1 (50565-1)

If swallowed, get medical help, or contact a Poison Control Center right away.

Section 50567-7 (50567-7)

Avoid contact with eyes, mucous membranes, rashes.

Do not apply to wounds or damaged skin.

If condition worsens, or if symptoms persist for more than 7 days or clear up and occur again within a few days, discontinue use of this product, and consult a doctor.

Section 50569-3 (50569-3)

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

Section 51727-6 (51727-6)

Water (Aqua), Ethyl Alcohol, Paraffinum Liquidum, Cetearyl Alcohol, Cetyl Alcohol, Stearic Acid, Dimethicone, Glyceryl Stearate, Tocopheryl Acetate, Glycereth-26, Caprylic/Capric Triglyceride, Polysorbate 60, Acrylamide/Sodium Acrylate Copolymer, Trideceth-6, Propylene Glycol, Stearyl Alcohol, Polysorbate 20, Diazolidinyl Urea, Triethanolamine, Cannabidiol, Methylparaben, Propylparaben, Sodium Hyaluronate, Sodium PCA, Wheat Amino Acids, Panthenol, Symphytum Officinale (Comfrey) Extract, Hydroxyproline, Sodium Benzotriazolyl Butylphenol Sulfonate, Buteth-3, Tributyl Citrate, FD&C Blue No.1 (CI 42090), FD&C Yellow No.5 (CI 19140).

Section 53413-1 (53413-1)

Contact us +1-305-468-8790

Section 53414-9 (53414-9)

If pregnant or breast – feeding

Ask a health professional before use.

Section 55105-1 (55105-1)

External Analgesic

Section 55106-9 (55106-9)



Camphor 3%

Menthol 10%

Directions: (DIRECTIONS:)

Adults and children over 12 years of age

Apply a thin layer to the affected area and rub gently not more than 3 to 4 times daily.

Wash hands with soap and water after use.

Children under 12 years of age; do not use unless directed by doctor.

Other Information: (OTHER INFORMATION:)

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

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Advanced Ingredient Data


Raw Label Data

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