Novathenol® (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
Tissue regeneration stimulant
Pharmacological Action
A tissue regeneration stimulator, it belongs to the B vitamins. Dexpanthenol is a precursor of pantothenic acid.
In the body, it is converted into pantothenic acid, which is a component of coenzyme A and is involved 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 a regenerating, metabolic, and weak anti-inflammatory effect.
Data obtained from animal experiments indicate an increase in fibroblast proliferation and the presence of a regenerating effect.
When applied externally and topically, Dexpanthenol is able to compensate for the increased need of damaged skin or mucous membranes for pantothenic acid.
Pharmacokinetics
Dexpanthenol is quickly absorbed through the skin and converted into pantothenic acid.
It binds to blood plasma proteins (mainly to 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 a thin layer of Novathenol® ointment or cream to the affected skin areas.
Gently rub in the preparation until fully absorbed.
For minor skin injuries, such as abrasions, cuts, and cracks, apply the product 1 to 3 times daily.
Use once or twice daily for the treatment and prevention of dry skin and for daily care of exposed areas like the face and hands.
In cases of sunburn or thermal burns, apply as needed to soothe and promote healing.
For diaper dermatitis or diaper rash in infants, apply with each diaper change, ensuring the skin is clean and dry before application.
For cracked nipples during lactation, apply a small amount after breastfeeding; there is no need to remove the product before the next feeding.
The duration of use depends on the severity of the condition and the healing progress.
Discontinue use and consult a physician if the condition worsens or if signs of an allergic reaction, such as redness or itching, appear.
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
Ointment for external use 5% (50 mg/1 g): tubes 25 g 1 pc. or 50 g 1 or 2 pcs.
Marketing Authorization Holder
Egis Pharmaceuticals PLC (Hungary)
Manufactured By
Jadran-Galenski Laboratorij, D.D. (Croatia)
Dosage Form
 |
Novathenol® | Ointment for external use 5% (50 mg/1 g): tubes 25 g 1 pc. or 50 g 1 or 2 pcs. |
Dosage Form, Packaging, and Composition
Ointment for external use homogeneous, light yellow in color, with a characteristic smell of lanolin.
| 1 g | |
| Dexpanthenol | 50 mg |
Excipients: preservative (phenoxyethanol, methylparahydroxybenzoate, ethylparahydroxybenzoate), lanolin, white beeswax, white soft paraffin, dimethicone, emulsifier (cetostearyl alcohol, sodium lauryl sulfate, sodium cetostearyl sulfate), propylene glycol, butylhydroxyanisole, butylhydroxytoluene, decamethylcyclopentasiloxane, magnesium sulfate heptahydrate, base (mountain wax, hydrogenated castor oil, glyceryl monostearate, butyric acid, white soft paraffin), purified water.
25 g – aluminum tubes (1) – cardboard boxes.
50 g – aluminum tubes (1) – cardboard boxes.
50 g – aluminum tubes (2) – cardboard boxes.
Cream for external use 5% (50 mg/1 g): tubes 25 g 1 pc. or 50 g 1 or 2 pcs.
Marketing Authorization Holder
Egis Pharmaceuticals PLC (Hungary)
Manufactured By
Jadran-Galenski Laboratorij, D.D. (Croatia)
Dosage Form
|
Novathenol® | Cream for external use 5% (50 mg/1 g): tubes 25 g 1 pc. or 50 g 1 or 2 pcs. |
Dosage Form, Packaging, and Composition
Cream for external use homogeneous, white in color, with a specific smell.
| 1 g | |
| Dexpanthenol | 50 mg |
Excipients: macrogol cetostearyl ether A6, macrogol cetostearyl ether A25, cetearyl 2-ethylhexanoate, cetyl alcohol, dimethicone, glyceryl monostearate 40-55 (type II), propylene glycol, methylparahydroxybenzoate, propylparahydroxybenzoate, flavor, purified water.
25 g – aluminum tubes (1) – cardboard boxes.
50 g – aluminum tubes (1) – cardboard boxes.
50 g – aluminum tubes (2) – cardboard boxes
![Novathenol® [Ointment, Cream] 1](https://www.medixlife.com/wp-content/uploads/Medixlife_favi_512.png "Novathenol® [Ointment, Cream] 2")