Bepanthen® (Ointment, Cream) Instructions for Use
ATC Code
D03AX03 (Dexpanthenol)
Active Substance
Dexpanthenol (Rec.INN registered by WHO)
Clinical-Pharmacological Group
A drug improving trophism and tissue regeneration, for external use
Pharmacotherapeutic Group
Drugs for the treatment of wounds and ulcers; drugs promoting normal scarring; other drugs promoting normal scarring
Pharmacological Action
A tissue regeneration stimulator, belongs to the B vitamins. Dexpanthenol is a precursor of pantothenic acid.
In the body, it is converted into pantothenic acid, which is a constituent part of coenzyme A and participates in acetylation processes, carbohydrate and fat metabolism, and in the synthesis of acetylcholine, corticosteroids, and porphyrins.
It stimulates the regeneration of the skin and mucous membranes, normalizes cellular metabolism, accelerates mitosis, and increases the strength of collagen fibers.
It has regenerating, metabolic, and weak anti-inflammatory effects.
Data obtained from animal experiments indicate an increase in fibroblast proliferation and the presence of a regenerating effect.
When applied externally and locally, Dexpanthenol is able to compensate for the increased demand of damaged skin or mucous membranes for pantothenic acid.
Pharmacokinetics
Dexpanthenol is rapidly absorbed by the skin and converted into pantothenic acid.
It binds to blood plasma proteins (mainly albumin and β-globulin).
Pantothenic acid is not metabolized in the body and is excreted unchanged.
Indications
Violation of the integrity of the skin: healing of burns (including sunburns), minor skin injuries (including abrasions, cuts, cracks); prevention and treatment of dry skin, including as a consequence of dermatitis of various origins; daily care of skin areas most exposed to external factors (face, hands); care for the mammary glands during lactation (cracks and redness of the nipples of the mammary gland); care for infants and babies (diaper rash, diaper dermatitis).
ICD codes
| ICD-10 code | Indication |
| L20 | Atopic dermatitis |
| L20.8 | Other atopic dermatitis (neurodermatitis, eczema) |
| L22 | Diaper dermatitis |
| L23 | Allergic contact dermatitis |
| L24 | Irritant contact dermatitis |
| L28.0 | Lichen simplex chronicus (circumscribed neurodermatitis) |
| L30.4 | Erythematous intertrigo |
| L30.9 | Dermatitis, unspecified |
| L55 | Sunburn |
| L56.2 | Photocontact dermatitis [berloque dermatitis] |
| O92.1 | Cracked nipple associated with childbirth |
| R23.4 | Changes in skin texture |
| T14.0 | Superficial injury of unspecified body region (including abrasion, bruise, contusion, hematoma, bite of nonvenomous insect) |
| T30 | Burns and corrosions of unspecified body region |
| ICD-11 code | Indication |
| 9A06.70 | Atopic eczema of the eyelids |
| EA80.0 | Infantile atopic eczema |
| EA80.1 | Childhood atopic eczema |
| EA80.2 | Adult atopic eczema |
| EA80.Z | Atopic eczema, unspecified |
| EA83.00 | Lichen simplex of vulva |
| EA83.01 | Lichen simplex of male genital organs |
| EA83.02 | Lichen simplex of perianal area |
| EA83.0Z | Lichen simplex of unspecified location |
| EA85.20 | Atopic hand eczema |
| EA85.2Z | Hand dermatitis, unspecified |
| EA85.3 | Foot dermatitis |
| EA89 | Generalized eczematous dermatitis of unspecified type |
| EA8Z | Dermatitis or eczema, unspecified |
| EE21 | Epidermal fragility |
| EH40.10 | Diaper dermatitis |
| EH92 | Dermatoses provoked by friction or mechanical impact |
| EH92.1 | Blister due to friction |
| EK00.Z | Allergic contact dermatitis, unspecified |
| EK02.20 | Intertriginous dermatitis due to friction, sweating or contact with body fluids |
| EK02.Z | Irritant contact dermatitis, unspecified |
| EK20 | Photoallergic reaction to fragrances or cosmetic products |
| JB46.1 | Cracked nipple associated with childbirth |
| KC30 | Fragile skin of prematurity |
| ME66.1 | Changes in skin texture |
| ND56.0 | Superficial injury of unspecified body region |
| NE11 | Burn 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 ointment or cream externally to the affected skin areas.
Gently rub in until fully absorbed.
For treatment of skin injuries such as cuts, abrasions, sunburns, or cracks, apply the product one to several times daily.
Use as needed to keep the affected area protected and moist.
For prevention and treatment of dry skin, apply regularly to dry or exposed areas like hands and face.
For diaper rash or diaper dermatitis in infants, apply with each diaper change to clean, dry skin.
For cracked and sore nipples during breastfeeding, apply a small amount after each feeding.
There is no need to remove the product before the next feeding.
Frequency of application depends on the indication and severity of the condition.
Continue use until the skin is fully healed.
Do not apply to deep or heavily infected wounds without medical supervision.
Avoid contact with eyes and mucous membranes.
If condition worsens or does not improve, discontinue use and consult a physician.
Adverse Reactions
In very rare cases, allergic reactions are possible.
Contraindications
Hypersensitivity to dexpanthenol.
Use in Pregnancy and Lactation
Can be used during pregnancy and breastfeeding.
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 DisclaimerBrand (or Active Substance), Marketing Authorisation Holder, Dosage Form
Cream for external use 5%: tubes 3.5 g, 30 g, or 100 g
Marketing Authorization Holder
BAYER, JSC (Russia)
Manufactured By
GP Grenzach Produktions, GmbH (Germany)
Dosage Form
 |
Bepanthen® | Cream for external use 5%: tubes 3.5 g, 30 g, or 100 g |
Dosage Form, Packaging, and Composition
Cream for external use 5% from white to white with a yellowish tint, soft, elastic, homogeneous, matte, with a weak specific odor.
| 1 g | |
| Dexpanthenol | 50 mg |
Excipients : D,L-pantolactone – 5 mg, phenoxyethanol – 5 mg, potassium cetyl phosphate (amphisol K) – 12.7 mg, cetyl alcohol – 24 mg, stearyl alcohol – 16 mg, lanolin – 13 mg, isopropyl myristate – 35 mg, propylene glycol – 15 mg, purified water – up to 1000 mg, potassium hydroxide* – q.s.
3.5 g – aluminum tubes with a polyethylene nozzle (1) – cardboard packs.
30 g – aluminum tubes with a polyethylene nozzle (1) – cardboard packs.
100 g – aluminum tubes with a polyethylene nozzle (1) – cardboard packs.
Ointment for external use 5%: tubes 3.5 g, 30 g, 50 g, or 100 g
Marketing Authorization Holder
BAYER, JSC (Russia)
Manufactured By
GP Grenzach Produktions, GmbH (Germany)
Dosage Form
|
Bepanthen® | Ointment for external use 5%: tubes 3.5 g, 30 g, 50 g, or 100 g |
Dosage Form, Packaging, and Composition
Ointment for external use 5% pale yellow, soft, elastic, homogeneous, opaque, with a weak smell of lanolin.
| 1 g | |
| Dexpanthenol | 50 mg |
Excipients : protegin X – 50 mg, cetyl alcohol – 18 mg, stearyl alcohol – 12 mg, white beeswax – 40 mg, lanolin – 250 mg, white soft paraffin – 130 mg, almond oil – 50 mg, liquid paraffin – 150 mg, purified water – up to 1000 mg.
3.5 g – lacquered aluminum tubes (1) – cardboard packs.
30 g – lacquered aluminum tubes (1) – cardboard packs.
50 g – lacquered aluminum tubes (1) – cardboard packs.
100 g – lacquered aluminum tubes (1) – cardboard packs.
![Bepanthen® [Ointment, Cream] 1](https://www.medixlife.com/wp-content/uploads/Medixlife_favi_512.png "Bepanthen® [Ointment, Cream] 2")