80465-003-04

80465-003-04
SPL v4
SPL
SPL Set ID b3495c95-ba4b-9459-e053-2a95a90a710f
Route
TOPICAL
Published
Effective Date 2024-03-30
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Menthol (3 g) Camphor (natural)
Inactive Ingredients
Propylene Glycol Alcohol Mineral Oil Hyaluronate Sodium Geraniol Cetyl Alcohol Dimethicone 1000 Glyceryl Stearate Se Glycereth-26 Methylparaben Stearyl Alcohol Trideceth-6 Propylparaben Panthenol Hydroxyproline Water Stearic Acid Diazolidinyl Urea Sodium Pyrrolidone Carboxylate Comfrey Linalool, (+/-)- Benzyl Benzoate Trolamine Coumarin Limonene, (+)- Amino Acids, Wheat Fd&c Blue No. 1

Identifiers & Packaging

Pill Appearance
Color: blue
Marketing Status
OTC MONOGRAPH DRUG Active Since 2020-11-04

Description

Menthol 3% Camphor 3%


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.

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 the 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 a doctor.

Description

Menthol 3% Camphor 3%

Section 50565-1

Keep out of reach of children, 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.

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

Section 50569-3

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

Section 51727-6

Water (Aqua), Paraffinum Liquidum, Alcohol Denat, Cetyl Alcohol, Dimethicone, Glyceryl Stearate, Stearic Acid, Glycereth-26, Propylene Glycol, Stearyl Alcohol, Acrylamide/Sodium Acrylate Copolymer, Trideceth-6, Triethanolamine, Fragrance (Parfum), Sodium Hyaluronate, Sodium PCA, Wheat Amino Acids, Panthenol, Symphytum Officinale (Comfrey) Extract, Hydroxyproline, Diazolidinyl Urea, Methylparaben, Propylparaben, FD&C Blue No.1 (CI 42090), Linalool, Limonene, Benzyl Benzoate, Coumarin, Geraniol.

Section 53414-9

If pregnant or breast – feeding

Ask a health professional before use.

Section 55105-1

External Analgesic

Section 55106-9

Menthol 3%

Camphor 3%

Section 60561-8

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

Cool Relief Cream


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 the 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 a doctor.

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.

If prone to allergic reaction to the product, consult to a doctor before using.

Section 50565-1 (50565-1)

Keep out of reach of children, 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.

If rash, redness or itchiness results; discontinue use 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), Paraffinum Liquidum, Alcohol Denat, Cetyl Alcohol, Dimethicone, Glyceryl Stearate, Stearic Acid, Glycereth-26, Propylene Glycol, Stearyl Alcohol, Acrylamide/Sodium Acrylate Copolymer, Trideceth-6, Triethanolamine, Fragrance (Parfum), Sodium Hyaluronate, Sodium PCA, Wheat Amino Acids, Panthenol, Symphytum Officinale (Comfrey) Extract, Hydroxyproline, Diazolidinyl Urea, Methylparaben, Propylparaben, FD&C Blue No.1 (CI 42090), Linalool, Limonene, 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)

External Analgesic

Section 55106-9 (55106-9)

Menthol 3%

Camphor 3%

Section 60561-8 (60561-8)

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

Cool Relief Cream (COOL RELIEF CREAM)


Advanced Ingredient Data


Raw Label Data

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