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Novopanten Plus (Cream) Instructions for Use

Marketing Authorization Holder

Genel RD, LLC (Russia)

Manufactured By

Samaramedprom, OJSC (Russia)

ATC Code

D08AC52 (Chlorhexidine in combination with other drugs)

Active Substances

Dexpanthenol (Rec.INN registered by WHO)

Chlorhexidine (Rec.INN registered by WHO)

Dosage Form

Bottle OTC Icon Novopanten Plus Cream for external use 5%+0.89%: 25 g, 30 g, 40 g, 50 g, or 100 g in a jar or tube

Dosage Form, Packaging, and Composition

Cream for external use is homogeneous, opaque, from white to light yellow in color with a faint characteristic odor.

1 g
Dexpanthenol 50 mg
Chlorhexidine digluconate (20% solution) 44.5 mg
   (calculated as Chlorhexidine digluconate) 8.9 mg

Excipients: pantolactone, cetyl alcohol, stearyl alcohol, lanolin, petrolatum, liquid paraffin, macrogol stearate, purified water.

25 g – jars (1) – cardboard packs.
30 g – jars (1) – cardboard packs.
40 g – jars (1) – cardboard packs.
50 g – jars (1) – cardboard packs.
100 g – jars (1) – cardboard packs.
25 g – aluminum tubes (1) – cardboard packs.
30 g – aluminum tubes (1) – cardboard packs.
40 g – aluminum tubes (1) – cardboard packs.
50 g – aluminum tubes (1) – cardboard packs.
100 g – aluminum tubes (1) – cardboard packs.

Clinical-Pharmacological Group

A drug improving trophism and tissue regeneration, for external use

Pharmacotherapeutic Group

Antiseptics and disinfectants; biguanides and amidines

Pharmacological Action

A combined medicinal product for external use. It has antimicrobial and anti-inflammatory effects and improves tissue regeneration.

Dexpanthenol is rapidly converted in skin cells into pantothenic acid, which plays an important role in both the formation and healing of damaged skin.

Chlorhexidine is an antiseptic active against vegetative forms of gram-negative and gram-positive bacteria, as well as yeasts, dermatophytes, and lipophilic viruses. It acts on bacterial spores only at elevated temperatures. It cleanses and disinfects the skin without causing damage. When applied to a wound surface, it protects against infection, promoting healing.

Indications

Minor wounds with a risk of infection (abrasions, scratches, minor cuts and scrapes, cracks, minor burns); infected superficial skin lesions; nipple cracks during breastfeeding; chronic wounds (e.g., trophic leg ulcers, bedsores); surgical wounds.

ICD codes

ICD-10 code Indication
I83.2 Varicose veins of lower extremities with ulcer and inflammation
L55 Sunburn
L89 Decubitus ulcer and pressure area
L98.4 Chronic skin ulcer, not elsewhere classified
O92.1 Cracked nipple associated with childbirth
T14.0 Superficial injury of unspecified body region (including abrasion, bruise, contusion, hematoma, bite of nonvenomous insect)
T14.1 Open wound of unspecified body region
T30 Burns and corrosions of unspecified body region
T79.3 Posttraumatic wound infection, not elsewhere classified
ICD-11 code Indication
BD74.Z Chronic venous insufficiency of lower extremities, unspecified
EA40 Tropical phagedenic ulcer
EF60 Ischemic ulceration of the skin
EH90.Z Pressure ulcer of unspecified degree
EH92 Dermatoses provoked by friction or mechanical impact
EH92.1 Blister due to friction
EM0Z Unspecified skin disorder
JB46.1 Cracked nipple associated with childbirth
ME60.2 Ulcerative skin lesion of unspecified nature
ND56.0 Superficial injury of unspecified body region
ND56.1 Open wound of unspecified body region
NE11 Burn of unspecified body region
NF0A.3 Posttraumatic wound infection, not elsewhere classified

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 a previously cleansed wound or affected skin area.

Use the cream once or several times daily, depending on the severity of the condition.

For minor wounds like abrasions, scratches, and minor burns, apply a thin layer of cream.

For chronic wounds such as trophic ulcers or bedsores, apply the cream more generously.

Treat nipple cracks during breastfeeding by applying a small amount after each feeding; thoroughly remove any residue before the next feeding.

Administer treatment using either an open method or by applying a sterile dressing.

For surgical wounds, follow the specific instructions provided by the healthcare professional.

Avoid contact with eyes, mucous membranes, and the middle ear.

Do not use on heavily contaminated, deep, or severe wounds without prior medical consultation.

If no improvement is seen within 10-14 days, or if symptoms worsen, discontinue use and consult a physician.

Adverse Reactions

Allergic reactions: urticaria, itching are possible.

Contraindications

For treatment or processing of the auricle; in case of severe, deep, and heavily contaminated wounds (such injuries require medical intervention); hypersensitivity to dexpanthenol and/or chlorhexidine.

Use in Pregnancy and Lactation

Can be used during pregnancy and breastfeeding, however, application to large skin areas should be avoided.

Geriatric Use

The drug is approved for use in elderly patients.

Special Precautions

Avoid contact with the eyes of products containing Dexpanthenol/chlorhexidine.

Do not take orally.

Large area lesions, heavily contaminated and deep wounds, as well as bite and puncture wounds require medical intervention (due to the risk of tetanus).

If the wound size remains consistently large for some time or the wound does not heal within 10-14 days, a doctor’s consultation is necessary. This is also necessary if the wound edges are severely hyperemic, the wound suddenly swells, severe pain appears, or the injury is accompanied by fever (due to the danger of sepsis development).

Drug Interactions

As a precaution regarding possible interaction (antagonism or inactivation), this combination should not be used simultaneously with other antiseptics.

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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