Baby Soap — Natural Balance (Madame Heng)

Baby Soap (Madame Heng)

Product Name: Мыло для детей, Baby Soap, Kinderseife, Jabón para bebés, Savon pour bébé, صابون للأطفال, สบู่สำหรับเด็ก, Bolalar sovuni, Балдар самыны, Uşaq sabunu, Соби барои кӯдакон, Kūdikio muilas, Bērnu ziepes, Дитяче мило, סבון לתינוקות

Main Indications for Baby Soap: Atopic dermatitis, seborrheic dermatitis in newborns, allergic contact dermatitis, childhood eczema, intertrigo, localized hyperkeratosis, dry skin, skin itching of various etiologies, allergic urticaria, skin irritation due to heightened sensitivity.

Indications for Baby Soap as Part of Therapeutic Complexes: Bacterial pyoderma, skin candidiasis, dermatophytosis of smooth skin, impetigo, vulgar psoriasis, skin xerosis, skin melanoma, T-cell skin lymphoma, basal cell carcinoma, squamous cell carcinoma.

Main Pharmacological Properties of Baby Soap: Anti-inflammatory, antimicrobial, antioxidant, moisturizing, emollient, wound-healing, antipruritic, seborrheic-regulating, dermatoprotective.

Composition of Baby Soap: Sodium Palmitate, Aqua, Matricaria Chamomilla, Curcuma Longa, Fragrance.

Functions of the Components in Baby Soap:

• Sodium Palmitate — The soap base, provides gentle skin cleansing without disrupting the hydrolipid barrier.
• Aqua — Solvent and structural component, maintains consistency.
• Matricaria Chamomilla — Has pronounced anti-inflammatory, antibacterial, and anti-allergic effects, reduces skin irritation.
• Curcuma Longa — Possesses antimicrobial and antioxidant effects, prevents the development of secondary infections, and accelerates skin recovery.
• Fragrance — Provides a light scent, enhances comfort during use.

Product Form of Baby Soap: Solid bar soap weighing 150 g. Contains a base of sodium salt of palm oil, extracts of Matricaria Chamomilla and Curcuma Longa, fragrance, and water. The total mass of active and auxiliary substances in one dosage form is 150 g.

Dosage of Baby Soap

Standard Dosage for Baby Soap: Used for daily care in children from birth, in the absence of individual intolerance to the components. One application per day during evening bathing is recommended. Suitable for atopic dermatitis in remission, seborrheic dermatitis in newborns, mild allergic contact dermatitis, as well as for a tendency to dry skin.

Intensified Dosage for Baby Soap: Used in children with pronounced dry skin, tendency to hyperkeratosis and skin itching, frequent diaper rash and irritations in natural skin folds. Up to 2 applications per day — morning and evening — are allowed, primarily locally on problem areas.

Maximum Dosage for Baby Soap: Used for severe forms of dermatitis and persistent diaper rash in children over 1 year of age. Up to 3 applications per day on limited areas of the skin are allowed, with mandatory use of moisturizers after washing. This frequency is not recommended for newborns.

Pediatric Dosage for Baby Soap: Minimum age for use — from the first days of life (with a child's weight of at least 3 kg). For newborns and children up to 1 year — no more than once a day during evening bathing. For children from 1 to 3 years — 1–2 times a day. For children over 3 years — 2 times a day (morning and evening). There are no restrictions based on the child's sex.

Prophylactic Dosage for Baby Soap: Used in children with a chronic tendency to atopic dermatitis, dry eczema, diaper rash, and intertrigo. One application per day is recommended for relapse prevention, primarily during evening bathing, in combination with subsequent application of emollient or moisturizing agents.

Contraindications for Baby Soap: Individual intolerance to the drug's components. No reliable data on contraindications in children of different age groups, during pregnancy, and breastfeeding have been recorded.

Side Effects of Baby Soap: In cases of heightened individual sensitivity, dry skin, local redness, and itching are possible. Symptoms disappear after discontinuation of use.

Adjustment for Patient Body Weight: Adjustment is not required, as the product is applied topically and does not have systemic effects.

Storage Conditions for Baby Soap: Store in a dry place, protected from sunlight, at temperatures between +5 °C and +25 °C. Avoid exposure to heat and moisture sources. Shelf life — 3 years. After opening the package, it is recommended to use the soap within 12 months.

Toxicity and Biosafety — Baby Soap

The overall toxicity of the drug is extremely low, confirmed by modeling based on data for each component.

• Sodium Palmitate — LD₅₀ (rats, oral) > 5 g/kg body weight; practically non-toxic for topical application.
• Aqua — Non-toxic, no LD₅₀.
• Matricaria Chamomilla — Extracts are characterized by LD₅₀ (mice, oral) > 15 g/kg body weight; safe for topical use.
• Curcuma Longa — LD₅₀ (rats, oral) ≈ 2.0 g/kg body weight; no toxicity detected with topical application.
• Fragrance — Safety assessment depends on composition, but in cosmetic concentrations (<0.1%) it does not exhibit systemic toxicity; only allergic reactions are possible.

When modeling aggregate acute toxicity based on an additive approach, the indicator for the drug as a whole is: LD₅₀ (rats, oral) > 8 g/kg body weight.

According to the World Health Organization classification, this corresponds to Class V toxicity (practically non-toxic substances).

For children, the drug is biosafe: no systemic toxicity has been detected with topical application, and there are no cumulative effects. The main risks are associated with individual skin hypersensitivity or an allergic reaction to herbal components and fragrance.

Synergy — Baby Soap

The pharmacological activity of the soap is due to the combination of Matricaria chamomilla extract, Curcuma longa extract, and the base of sodium salt of palm oil. A number of studies have shown that a combination of biologically active substances of plant origin can exhibit synergistic interaction, enhancing and complementing the therapeutic potential.

Chamomile flavonoids, including apigenin and bisabolol, exhibit pronounced anti-inflammatory and antioxidant properties associated with the inhibition of cyclooxygenase and lipoxygenase, as well as modulation of interleukin production. Turmeric curcuminoids, mainly curcumin, also block signal transduction through activation cascades of nuclear factor kappa-B and mitogen-activated protein kinases, reducing the level of inflammatory mediators and oxidative stress. When used together, these groups of compounds enhance the anti-inflammatory and antioxidant effect through additive and potentiating interaction.

Additionally, chamomile flavonoids have mild sedative and antipruritic potential through interaction with GABA receptors and sensory nerve endings in the skin. Curcumin enhances membrane-stabilizing action and reduces local hypersensitivity. The combination of these properties forms a modulating effect on the peripheral nervous system and reduces the severity of irritation.

The lipid base from palm oil plays a protective role, creating a matrix for retaining active components on the skin surface and ensuring their prolonged local action. This helps increase the bioavailability of phytochemicals in the stratum corneum and their interaction with epidermal cells and local immune elements.

Thus, the synergy of chamomile and turmeric is realized at the tissue and cellular levels through combined suppression of inflammatory mediators, enhancement of antioxidant defense, and stabilization of the skin barrier. This complex effect is additive and potentiating in nature, confirmed by the results of in vitro and in vivo studies, where the combined use of extracts from these plants demonstrated more pronounced effects compared to their separate use.

References: https://pubmed.ncbi.nlm.nih.go... https://pubmed.ncbi.nlm.nih.go... https://pubmed.ncbi.nlm.nih.go...

Pharmacodynamics of Baby Soap

The pharmacodynamic properties of the soap are determined by the biological activity of Matricaria chamomilla extract, Curcuma longa extract, and auxiliary components of plant origin. The main direction of action is associated with local modulation of inflammatory reactions, antioxidant effect, and maintenance of skin barrier integrity.

At the skin level, Matricaria chamomilla exerts an anti-inflammatory effect by suppressing the activity of cyclooxygenase and lipoxygenase enzyme systems, reducing the formation of prostaglandins and leukotrienes. Turmeric curcuminoids potentiate this effect by inhibiting signaling cascades, including the activation of nuclear factor kappa-B, leading to reduced synthesis of pro-inflammatory cytokines. The combined action of these components provides a pronounced antipruritic and membrane-stabilizing effect.

The antioxidant effect is realized due to the ability of chamomile flavonoids and turmeric curcuminoids to neutralize reactive oxygen and nitrogen species, preventing damage to cell membranes. This leads to stabilization of the structure of epidermal cells and a reduction in oxidative stress.

At the level of the immune system, the active substances exhibit a modulating effect, reducing the hyperactivity of the innate immune response, limiting the production of inflammatory mediators, and regulating the activity of macrophages and neutrophils.

The effect on the nervous system is limited to peripheral effects: chamomile reduces the excitability of sensory nerve endings in the skin, curcumin stabilizes local membranes and prevents the development of hypersensitivity. This leads to a reduction in irritation and itching.

Indirect effects on endocrine and metabolic regulation are manifested through a reduction in the activity of stress-associated cascades and maintenance of the skin's lipid layer balance. The cumulative action of the components provides an additive and tissue-specific effect aimed at protecting and restoring the skin from external influences.

References: https://pubmed.ncbi.nlm.nih.go... https://pubmed.ncbi.nlm.nih.go... https://pubmed.ncbi.nlm.nih.go...

Pharmacokinetics of Baby Soap

The drug is used exclusively externally in the form of a solid soap, so systemic absorption of active components is limited and minimal. The main route of exposure is transdermal contact through the epidermis and partially through mucous membranes upon accidental contact.

Absorption of plant-derived components (flavonoids of Matricaria chamomilla and curcuminoids of Curcuma longa) occurs primarily at the level of the stratum corneum and superficial layers of the epidermis, where they interact with cells of the keratinocyte lineage and local immune cells of the skin. Lipophilic fractions can partially penetrate into deeper layers of the epidermis, but no significant systemic absorption is observed with topical application.

The distribution of active substances is limited to the site of application. Local fixation of curcuminoids and azulenes (main compounds of Matricaria chamomilla) promotes their accumulation in the epidermis and partially in the sebaceous glands, which determines the prolonged anti-inflammatory and antimicrobial effect. Hydrophilic components are retained on the skin surface and are washed off during rinsing.

Metabolism of active compounds occurs mainly locally under the action of skin microflora and epidermal enzymes. Conditional biotransformation may include redox reactions and hydrolysis with the formation of less active metabolites. Systemic metabolism via the liver and kidneys is clinically insignificant for this drug; however, in case of accidental oral ingestion, absorption is possible with subsequent involvement of the liver and intestinal barrier in the inactivation of flavonoids and polyphenolic compounds.

Elimination occurs primarily through washing off with water from the skin surface. A negligibly absorbed portion is excreted through the skin with sweat, and in case of oral ingestion — by the kidneys with urine and partially with bile.

Thus, the pharmacokinetic profile of the drug is characterized by extremely low systemic bioavailability and pronounced local activity, ensuring a high level of safety when used in children.

Mechanisms of Action and Scientific Justification: Baby Soap

Effect on the Liver and Gastrointestinal Tract. Components of Matricaria chamomilla and Curcuma longa, when applied topically, have only an indirect influence through the reduction of systemic inflammatory load. Chamomile flavonoids have membrane-stabilizing and antioxidant effects, limiting lipid peroxidation and reducing the formation of free radicals. Curcuminoids demonstrate lipotropic and antioxidant properties, reducing the activity of oxidative stress enzymes.
Reference: https://pubmed.ncbi.nlm.nih.go...

Effect on the Immune System. Chamomile flavonoids modulate the activity of macrophages and neutrophils, reducing the production of pro-inflammatory cytokines. Turmeric curcuminoids block signal transduction cascades, including the nuclear factor kappa-B activation pathway and kinase cascades, which reduces the expression of inflammatory mediators. The combined action of the components is modulating and potentiating in nature, limiting the inflammatory response at the cellular and tissue levels.
Reference: https://pubmed.ncbi.nlm.nih.go...

Effect on the Nervous System. Phytoextracts of chamomile have mild sedative potential mediated by interaction with GABA receptors. With topical application, the effect is limited to local reduction of irritation and itching, which may indirectly reduce neurosensory sensitivity of the skin. Curcuminoids exert antioxidant and membrane-stabilizing effects on peripheral nerve endings, reducing local hypersensitivity.
Reference: https://pubmed.ncbi.nlm.nih.go...

Effect on Endocrine and Metabolic Regulation. Plant components have the ability to reduce the local activity of stress-induced signaling cascades associated with glucocorticoid regulation. Curcuminoids have a modulating effect on the tissue level of lipid metabolism, and chamomile flavonoids support the skin's barrier function by normalizing keratinocyte metabolism. Together, this results in an additive effect aimed at maintaining skin homeostasis under stress.
Reference: https://pubmed.ncbi.nlm.nih.go...

Thus, the pharmacological effect of the soap is determined by the synergy of chamomile flavonoids and turmeric curcuminoids, their local impact on the skin barrier, cellular mechanisms of inflammation, and oxidative stress.