83037-015-04

83037-015-04
SPL v1
SPL
SPL Set ID 159c301c-d462-bb2c-e063-6394a90a9e5a
Route
TOPICAL
Published
Effective Date 2024-04-20
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Menthol, Unspecified Form (1.5 g)
Inactive Ingredients
Eucalyptus Oil Polysorbate 60 Dimethyl Sulfone Mineral Oil Glyceryl Stearate Se Acrylic Acid/sodium Acrylate Copolymer (1:1; 600 Mpa.s At 0.2%) Amino Acids, Wheat Panthenol Alcohol Stearic Acid Cetostearyl Alcohol Cetyl Alcohol Dimethicone Glycereth-26 Sodium Chondroitin Sulfate (porcine; 5500 Mw) Glucosamine Sulfate Caprylyl Glycol Sodium Hydroxide Symphytum Officinale Whole Hydroxyproline Stearyl Alcohol Trideceth-6 Hyaluronate Sodium Sodium Pyrrolidone Carboxylate Phenoxyethanol Hexylene Glycol Polysorbate 20 Water

Identifiers & Packaging

Pill Appearance
Color: white
Marketing Status
OTC MONOGRAPH DRUG Active Since 2024-04-20

Description

Menthol 1.5%


Medication Information

Warnings and Precautions

•For external use only.

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

Description

Menthol 1.5%

Use

For the temporary relief of minor aches and pains of muscles and joints associated arthritis

Section 50565-1

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

Section 50567-7

Avoid contact with the eyes or mucous membranes.

Do not apply to wounds or damaged skin.

Do not apply to the irritated skin or if excessive irritation develops.

Do not bandage tightly.

Do not use with heating pad or device.

Stop use and ask a doctor if condition worsens, or if symptoms persist for more than 7 days, or clear up and occur again within a few days.

Section 51727-6

Water (Aqua), Paraffinum Liquidum, Alcohol Denat, Cetearyl Alcohol, Cetyl Alcohol, Stearic Acid, Dimethicone, Glyceryl Stearate, Eucalyptus Globulus Leaf Oil, Glycereth-26, Polysorbate 60, Methylsulfonylmethane (MSM), Sodium Chondroitin Sulfate, Glucosamine Sulfate, Sodium Hyaluronate, Sodium PCA, Wheat Amino Acids, Panthenol, Symphytum Officinale (Comfrey) Extract, Hydroxyproline, Acrylamide/Sodium Acrylate Copolymer, Trideceth-6, Stearyl Alcohol, Polysorbate 20, Caprylyl Glycol, Sodium Hydroxide, Phenoxyethanol, Hexylene Glycol.

Section 53414-9

If pregnant or breast – feeding

Ask a health professional before use.

Section 55105-1

Topical Analgesic

Section 55106-9

Menthol 1.5%

Directions

Adults and Children over 12 years

Apply a small amount on the affected area.

Massage in circular motion, let set for a few seconds.

Repeat as necessary, but no more than 3 to 4 times daily.

Children under 12 years of age: Do not use, consult a doctor.

Other Information

Store tightly closed in a dry place at controlled room temperature between 59-86 F (15°-30° C).

Dzul Arthritis Pain Relief Cream


Structured Label Content

Use (USE)

For the temporary relief of minor aches and pains of muscles and joints associated arthritis

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 50567-7 (50567-7)

Avoid contact with the eyes or mucous membranes.

Do not apply to wounds or damaged skin.

Do not apply to the irritated skin or if excessive irritation develops.

Do not bandage tightly.

Do not use with heating pad or device.

Stop use and ask a doctor if condition worsens, or if symptoms persist for more than 7 days, or clear up and occur again within a few days.

Section 51727-6 (51727-6)

Water (Aqua), Paraffinum Liquidum, Alcohol Denat, Cetearyl Alcohol, Cetyl Alcohol, Stearic Acid, Dimethicone, Glyceryl Stearate, Eucalyptus Globulus Leaf Oil, Glycereth-26, Polysorbate 60, Methylsulfonylmethane (MSM), Sodium Chondroitin Sulfate, Glucosamine Sulfate, Sodium Hyaluronate, Sodium PCA, Wheat Amino Acids, Panthenol, Symphytum Officinale (Comfrey) Extract, Hydroxyproline, Acrylamide/Sodium Acrylate Copolymer, Trideceth-6, Stearyl Alcohol, Polysorbate 20, Caprylyl Glycol, Sodium Hydroxide, Phenoxyethanol, Hexylene Glycol.

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)

Menthol 1.5%

Directions (DIRECTIONS)

Adults and Children over 12 years

Apply a small amount on the affected area.

Massage in circular motion, let set for a few seconds.

Repeat as necessary, but no more than 3 to 4 times daily.

Children under 12 years of age: Do not use, consult a doctor.

Other Information (OTHER INFORMATION)

Store tightly closed in a dry place at controlled room temperature between 59-86 F (15°-30° C).

Dzul Arthritis Pain Relief Cream (DZUL ARTHRITIS PAIN RELIEF CREAM)


Advanced Ingredient Data


Raw Label Data

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