DexPenol plus (Cream) Instructions for Use

Marketing Authorization Holder

Beringer, LLC (Russia)

Manufactured By

Lok-Beta Pharmaceuticals (India), Private Limited (India)

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

DexPenol plus

Cream for external use 50 mg+5 mg: 30 g tube

Dosage Form, Packaging, and Composition

Cream for external use is homogeneous, matte, from white to white with a yellowish tint and a faint characteristic odor.

Excipients: pantolactone – 5 mg, cetyl alcohol – 36 mg, stearyl alcohol – 24 mg, lanolin – 30 mg, white soft paraffin – 100 mg, macrogol stearate – 30 mg, purified water – up to 1 g.

30 g – aluminum tubes (1) – cardboard packs.

Clinical-Pharmacological Group

A drug with antimicrobial, anti-inflammatory, and tissue regeneration-improving action for external use

Pharmacotherapeutic Group

Tissue regeneration stimulant

Pharmacological Action

Combined medicinal product for external use. It has antimicrobial and anti-inflammatory action 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 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

Dosage Regimen

Apply the cream externally to a pre-cleaned wound surface or inflamed skin areas.

Use the cream once or several times a day depending on the severity of the condition.

For minor wounds like abrasions, scratches, and minor burns, apply a thin layer to cover the affected area completely.

Treat chronic wounds such as trophic ulcers and bedsores by applying the cream directly to the cleansed wound bed.

For cracked nipples during breastfeeding, apply a small amount after each feeding; thoroughly wipe the nipple before the next feeding.

Administer using either the open method or under a sterile dressing; change dressings as required by the clinical situation.

Do not apply to the auricle or into the eyes.

Avoid use on heavily contaminated, deep, or severe wounds which require medical intervention.

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 eyes of preparations 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 over 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.