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Deep Heat (Cream) Instructions for Use

Marketing Authorization Holder

Mentholatum Company, Ltd. (United Kingdom)

ATC Code

M02AC (Preparations with salicylic acid derivatives)

Dosage Form

Bottle OTC Icon Deep Heat Cream for external use: 15 g, 35 g, 67 g, or 100 g tubes

Dosage Form, Packaging, and Composition

Cream for external use from white to almost white in color, homogeneous, with a characteristic odor.

1 g
Methyl salicylate 128 mg
Racemic menthol 59.1 mg
Eucalyptus oil 19.7 mg
Turpentine oil 14.7 mg

Excipients: cetearyl alcohol (cetyl alcohol 60%, stearyl alcohol 40%) – 180 mg, sodium cetylstearyl sulfate – 20 mg, liquid paraffin – 10 mg, propylene glycol – 10 mg, anhydrous lanolin – 5 mg, purified water – 553.5 mg.

15 g – lacquered aluminum tubes (1) – cardboard boxes.
35 g – lacquered aluminum tubes (1) – cardboard boxes.
67 g – lacquered aluminum tubes (1) – cardboard boxes.
100 g – lacquered aluminum tubes (1) – cardboard boxes.

Clinical-Pharmacological Group

Drug with local irritant and analgesic action

Pharmacotherapeutic Group

Local irritant

Pharmacological Action

Combined drug for external use.

Methyl salicylate penetrates the skin, exerting an analgesic and anti-inflammatory effect.

Purified turpentine oil (Turpentine oil) when applied externally causes a reflex increase in blood flow, which promotes the accelerated absorption of active components.

Eucalyptus oil when applied externally has a local irritant effect.

The combination of the drug’s components stimulates local blood circulation in the tissues, causing a warming sensation at the site of application. The action of the drug containing this combination leads to the relief of muscle and joint pain.

Indications

Symptomatic relief of muscle pain (including low back pain with sciatica, lumbago, fibrositis, sprains, bruises); rheumatic pain; muscle rubbing before and after sports training.

ICD codes

ICD-10 code Indication
M05 Seropositive rheumatoid arthritis
M25.5 Pain in joint
M54.1 Radiculopathy
M54.3 Sciatica
M54.4 Lumbago with sciatica
M54.9 Dorsalgia, unspecified
M79.0 Unspecified rheumatism
M79.1 Myalgia
M79.7 Fibromyalgia (including fibromyositis, fibrosis)
T14.0 Superficial injury of unspecified body region (including abrasion, bruise, contusion, hematoma, bite of nonvenomous insect)
T14.3 Dislocation, sprain and strain of joint and ligament of unspecified body region
ICD-11 code Indication
8B93.Z Radiculopathy, unspecified
8E4A.1 Paraneoplastic or autoimmune diseases of the peripheral or autonomic nervous system
EH92 Dermatoses provoked by friction or mechanical impact
EH92.1 Blister due to friction
FA20.0 Seropositive rheumatoid arthritis
FA27.2 Palindromic rheumatism
FB51.3 Fibroblastic rheumatism
FB56 Specified soft tissue diseases, not elsewhere classified
FB56.2 Myalgia
ME82 Pain in joint
ME84.20 Lumbago with sciatica
ME84.3 Sciatica
ME84.Z Back pain, unspecified
MG30.01 Chronic widespread pain
ND56.0 Superficial injury of unspecified body region
ND56.3 Dislocation, sprain or strain of unspecified body region

Dosage Regimen

The method of application and dosage regimen for a specific drug depend on its form of release and other factors. The optimal dosage regimen is determined by the doctor. It is necessary to strictly adhere to the compliance of the dosage form of a specific drug with the indications for use and dosage regimen.

Apply the cream externally to intact skin only.

For adults and children over 12 years of age, apply a thin layer to the painful area.

Rub the cream gently into the skin until it is completely absorbed.

Use the product 2 to 3 times per day as needed for pain relief.

For children aged 5 to 12 years, apply no more than 2 times per day.

Use is contraindicated in children under 5 years of age.

Limit the application area; do not use on large areas of the body.

Wash hands thoroughly with soap and water immediately after application.

Avoid contact with eyes, mucous membranes, and broken or irritated skin.

Do not apply with an occlusive dressing or bandage.

Discontinue use if severe or persistent skin irritation occurs.

Seek medical advice if symptoms worsen or do not improve after 7 days of use.

Consult a physician before using this product if you are taking other medications, especially anticoagulants or methotrexate.

A doctor’s consultation is mandatory after 2 weeks of continuous use.

Adverse Reactions

Allergic reactions itching, redness, urticaria.

With long-term use in high doses, the development of systemic side effects is possible.

Contraindications

Hypersensitivity to the components of the combination; bronchial asthma provoked by the intake of acetylsalicylic acid or other NSAIDs; impaired skin integrity; children under 5 years of age; pregnancy, breastfeeding period.

Use in Pregnancy and Lactation

Use is contraindicated during pregnancy and breastfeeding.

Pediatric Use

Should not be used in children under 12 years of age without consulting a doctor.

Special Precautions

Should be applied to intact skin, avoiding contact with eyes and mucous membranes. Occlusive dressings should not be used.

If the patient is using other medications, a doctor’s consultation is necessary before using the drug.

Use in pediatrics

Should not be used in children under 12 years of age without consulting a doctor.

Drug Interactions

Methyl salicylate enhances the effect of anticoagulants, methotrexate upon absorption, which should be taken into account when using this agent in high doses for a long time.

Storage Conditions

Store at 2°C (36°F) to 25°C (77°F). Keep in original packaging, protected from light. Keep out of reach of children.

Dispensing Status

Over-the-Counter

Important Safety Information

This information is for educational purposes only and does not replace professional medical advice. Always consult your doctor before use. Dosage and side effects may vary. Use only as prescribed.

Medical Disclaimer

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