Acnorm Box

Acnorm Box Uses, Dosage, Side Effects, Food Interaction and all others data.

Allantoin is a substance that is endogenous to the human body and also found as a normal component of human diets . In healthy human volunteers, the mean plasma concentration of allantoin is about 2-3 mg/l. During exercise, the plasma allantoin concentration rapidly increases about two fold and remains elevated . In human muscle, urate is oxidized to allantoin during such exercise . The concentration of allantoin in muscles increases from a resting value of about 5000 ug/kg to about 16000 ug/kg immediately after short-term exhaustive cycling exercise .

More specifically, allantoin is a diureide of glyoxylic acid that is produced from uric acid. It is a major metabolic intermediate in most organisms. Allantoin is found in OTC cosmetic products and other commercial products such as oral hygiene products, in shampoos, lipsticks, anti-acne products, sun care products, and clarifying lotions . Allantoin has also demonstrated to ameliorate the wound healing process in some studies .

There is no well controlled and appropriate data that can formally substantiate the pharmacodynamic properties of allantoin . Nevertheless, ongoing studies suggest that allantoin possesses moisturizing and keratolytic effects, as well as abilities to increase the water content of the extracellular matrix and enhance the desquamation of upper layers of dead skin cells, all of which are activities that can promote cell proliferation and facilitate wound healing .

Tea tree oil is an essential oil derived mainly from the Australian native plant Melaleuca alternifolia via steam distillation of the of the leaves and terminal branches . It may be referred to as Melaleuca alternifolia oil. It has been a popular ingredient in a variety of household and cosmetic products due to its antiseptic, anti-inflammatory, broad-spectrum antimicrobial and antioxidant properties . The dermatological use of tea tree oil has been investigated by various studies, where several studies have suggested the uses of this oil for the treatment of acne vulgaris, seborrheic dermatitis, and chronic gingivitis . Terpene hydrocarbons and related alcohols constitute tea tree oil, with Terpinen-4-ol being the major antimicrobial component .

Tea tree oil exhibits antibacterial, antifungal, antiviral, and antiprotozoal activities . It mostly mediates bactericidal actions at concentrations of 1.0% or less in most bacteria such as Staphylococcus aureus and Escherichia coli, and causes bacteriostatic effects at lower concentrations . Organisms such as commensal skin staphylococci and micrococci, Enterococcus faecalis, and Pseudomonas aeruginosaemphasized text were susceptible to tea tree oil concentrations of 2% . It is proposed that water-soluble components of tea tree oil are capable in inducing anti-inflammatory actions; terpinen-4-ol attenuates the vasodilation and plasma extravasation associated with histamine-induced inflammation in humans .

An aromatic ether that is phenol which is substituted at C-5 by a chloro group and at C-2 by a 2,4-dichlorophenoxy group. It is widely used as a preservative and antimicrobial agent in personal care products such as soaps, skin creams, toothpaste and deodorants as well as in household items such as plastic chopping boards, sports equipment and shoes.

Zinc oxide is used to treat or prevent minor skin irritations such as burns, cuts, poison ivy, poison oak, poison sumac, and diaper rash. It is also used as a sunscreen.

Zinc oxide has astringent, soothing and protective properties and is used in topical preparations for eczema, slight excoriations, wounds and haemorrhoids. It also reflects ultraviolet radiation and can be used as a physical sunscreen.

Trade Name Acnorm Box
Generic Tea Tree Oil + Triclosan + Zinc Oxide + Allantoin + Vitamin E / Tocopherol
Weight 0.5%w/w
Type Soap
Therapeutic Class
Manufacturer Tergum Remedies Pvt Ltd
Available Country India
Last Updated: September 19, 2023 at 7:00 am
Acnorm Box
Acnorm Box

Uses

Allantoin is an ingredient used in skin care products to relieve irritation and protect minor cuts, scrapes, and burns.

Allantoin is commonly applied in a variety of topical vehicles or applications such as cosmetic creams, toothpastes, mouthwashes, shampoos, lipsticks, anti-acne products, and lotions for the purpose of moisturizing skin, enhancing the smoothness of skin, stimulating the healing of wounds, and soothing irritated skin .

Indicated for topical use to help protect against infection in minor cuts, scrapes, and burns. No FDA-approved therapeutic indications.

Triclosan is an antimicrobial agent in clinical setting for disinfection, and prevention of spread and growth of bacteria, fungus, and mildew.

Triclosan is used in a variety of common household products, including soaps, mouthwashes, dish detergents, toothpastes, deodorants, and hand sanitizers. It is also used in health care settings in surgical scrubs and personnel hand washes.

Zinc Oxide helps to To treat or prevent skin irritations (e.g., burns, bed sore, cuts, poison ivy, diaper rash). Protects chafed skin due to diaper rash and helps seal out wetness.

Acnorm Box is also used to associated treatment for these conditions: Scarring, Dental cleaning, Skin Lightening, Skin protectionAcne, Dental Cavity, Dermabrasion, Gingivitis, Oral Infection, Plaque, Dental, Skin Infections, Bacterial, Abrasions, Minor burns, Antibacterial therapy, Antibiotic pre-surgical prophylaxisAcute Wounds, Burns first degree, Burns second degree, Dermatitis, Eczematous, Diaper Rash, Herpes Labialis, Injuries to the Nipple (Fissures and Cracks) Resulting Breastfeeding, Intertrigo, Pain, Pruritus, Sensitive Skin, Skin Irritation, Skin candida, Sunburn, Wounds, Chafing, Damaged skin, Dry, cracked skin, Facial rash, Heat rash, Superficial Wounds, Watery skin lesions, Astringent, Nutritional supplementation

How Acnorm Box works

There is no well controlled data that can formally substantiate the method of action . However, ongoing studies suggest that there may exist a histological wound healing profile induced by allantoin in rats that leads to the amelioration and fastening of the reestablishment of normal skin . This facilitation of wound healing is supported by observations that wounds inflicted to rat subjects to which topical allantoin preparations were applied histologically demonstrated increased vasodilation, presence of inflammatory exudates, number of inflammatory cells, angiogenesis, fibroblast proliferation, and increased collagen deposition when compared to rat subjects with wounds that did not receive any allantoin administration .

The components of tea tree oil, particularly terpinen-4-ol and α-terpineol, mediate antimicrobial actions by disrupting the structural and functional integrity of bacterial membrane. Hydrocarbons are capable of partitioning into the cell and cytoplasmic membrane of microorganisms and disrupt their vital functions, which may result in leakage of ions such as potassium, and the inhibition of respiration . Eventually, cell lysis may occur due to weakening of the cell wall, and loss of turgor pressure and subsequent rupture of the cytoplasmic membrane . The loss of 260-nm-absorbing material may be indicative of a damaged cytoplasmic membrane and loss of nucleic acids . In E. coli, perturbed potassium homeostasis, glucose-dependent respiration, cell morphology, and ability to exclude propidium iodide was observed.

Tea tree oil also mediates its antifungal actions in a similar way, where it alters the permeability of Candida albicans and inhibits its respiration in a dose-dependent manner . Plasma and mitochondrial membranes of fungal species are also thought to be negatively affected by inhibition of glucose-induced medium acidification by tea tree oil, which involves inhibition of membrane ATPase responsible for the expulsion of protons . Tea tree oil also inhibits the formation of germ tubes, or mycelial conversion, in C. albicans, thereby disrupting cell morphogenesis . Water-soluble fraction of TTO, terpinen-4-ol, and α-terpineol, can inhibit the lipopolysaccharide-induced production of the inflammatory mediators such as TNF-α, IL-1β and IL-10 by human peripheral monocytes by approximately 50% and that of prostaglandin E2 by about 30% after 40 h . These components of tea tree oil may also suppress superoxide production by agonist-stimulated monocytes and decrease the production of reactive oxygen species by both stimulated neutrophils and monocytes .

Triclosan is a biocidal compound with multiple targets in the cytoplasm and membrane. At lower concentrations, however, triclosan appears bacteriostatic and is seen to target bacteria mainly by inhibiting fatty acid synthesis. Triclosan binds to enoyl-acyl carrier protein reductase enzyme (ENR). This complex has increased affinity for NAD+ and forms a ternary complex. This complex is unable to participate in fatty acid synthesis, weakening the cell membrane and causing cell death. Humans do not have an ENR enzyme, and thus are not affected.

It acts by providing a physical barrier to prevent skin irritation and help heal damaged skin.

Dosage

Acnorm Box dosage

Apply thin layer topically every 8 hourly. Change wet and soiled diapers, promptly cleans the diaper area, allow to dry and apply ointment liberally as often as necessary, with each diaper change, especially at bedtime or any time when exposure to wet diapers may be prolonged.

Side Effects

Usually well tolerated. Extremely low frequency of hypersensitivity reaction.

Toxicity

No studies on repeated dose toxicity and reproductive toxicity have been submitted. Moreover, studies show that the tumor incidence in allantoin treated animals did not differ largely from that found in untreated controls. As a result, further or additional toxicity, mutagenicity, or carcinogenicity tests are not required in view of the endogenous nature of allantoin and the general lack of overall toxicity .

Finally, as allantoin is a normal component of the diet in humans and is a substance of endogenous origin present in the body of humans, it is generally recognized as being a safe substance for humans .

The 50% lethal dose for TTO in a rat model is 1.9 to 2.6 mL/kg, and doses ≤1.5 g/kg was associated with ataxia and lethargy. Dermal patches containing 10% of tea tree oil was not associated with any irritant reactions. Topically-applied tea tree oil rarely causes systemic toxicity . Dermal application of approximately 120 ml of undiluted tea tree oil to three cats with shaved but intact skin resulted in symptoms of hypothermia, uncoordination, dehydration, and trembling and in the death of one of the cats .

Oral LD50, Rat: 3700 mg/kg; Dermal LD50, Rabbit: 9300 mg/kg

Acute oral toxicity (LD50): 7950 mg/kg [Mouse].

Precaution

For external use only. Avoid contact with the eyes. Stop use and ask a doctor if condition worsens or does not improve within 7 days. Keep out of the reach of children. If swallowed, get medical help or contact a poison control center right away

Volume of Distribution

No pharmacokinetic data available.

Intended for local use only, no systemic absorption.

Elimination Route

In studies on human subjects, a recovery of 19% and 34% of allantoin in the urine was observed but only in two individuals and only after the administration of massive doses of allantoin . After intravenous administration, recovery in the urine was practically quantitative with doses of 75 to 600 mgm in the human model . After 240 mgm, excretion continued for 72 hours in human subjects and the results were similar in regards to subcutaneous injection .

No pharmacokinetic data available.

A study conducted in 2000 demonstrated that low amounts of triclosan can be absorbed through skin and can enter the bloodstream. [PMID: 10722890] Triclosan is rapidly absorbed and distributed in the human body (Sandborgh-Englund et al., 2006). Maximum concentrations are reached within three hours after oral intake. However, the metabolism and excretion of the compound is fast.

No significant percutaneous absorption from topically applied zinc oxide.

Half Life

When studied in cattle, sheep, and horses, the half-life of allantoin is in the range of 1 to 2.5 hours .

No pharmacokinetic data available.

The terminal plasma half life of triclosan is 21 h (Sandborgh-Englund et al., 2006).

Intended for local use only, no systemic absorption.

Clearance

Some studies suggest that the average renal clearance of allantoin in normal, healthy human subjects is approximately 123 cc per minute . It is generally agreed upon that exogenously administered allantoin is rapidly excreted .

No pharmacokinetic data available.

Intended for local use only, no systemic absorption.

Elimination Route

Urinary clearance is the predominant excretion route .

No pharmacokinetic data available.

In one study, after in vivo topical application of a 64.5mM alcoholic solution of [(3)H]triclosan to rat skin, 12% radioactivity was recovered in the faeces, 8% in the carcass 1% in the urine, 30% in the stratum corneum and 26% was rinsed from the skin surface at 24 hours after application. [PMID: 10722890]

Intended for local use only, no systemic absorption.

Pregnancy & Breastfeeding use

This medication should be used with precautions only if clearly needed during pregnancy or while breast feeding

Contraindication

Known hypersensitivity to any component of the preparation

Acute Overdose

No overdose related problem is yet reported.

Storage Condition

keep in a cool and dry place, away from light.

Innovators Monograph

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