Itchnil

• Relief of pruritus (itching):
  Used to alleviate itching associated with minor skin irritations such as insect bites, poison ivy/oak/sumac, minor burns, cuts, scrapes, eczema, and dermatitis.
• Soothing agent for minor skin conditions:
  Provides symptomatic relief in cases of sunburn, rashes, and other superficial dermatologic conditions causing discomfort.
• Off-label uses:
  Adjunct treatment for symptomatic relief in mild inflammatory skin conditions.

• Adults and children over 2 years:
  Apply a thin layer topically to the affected area 3–4 times daily or as directed by a physician.
• Pediatrics (under 2 years):
  Use only under medical supervision due to limited safety data.
• Administration:
  External use only. Clean and dry the affected area before application. Avoid contact with eyes, mouth, and mucous membranes.
• Duration:
  Use for the shortest duration necessary to relieve symptoms; prolonged use should be under medical advice.
• Dose adjustments:
  Not applicable.

Pramoxine hydrochloride is a topical anesthetic that blocks nerve conduction by stabilizing neuronal membranes, inhibiting the transmission of pain and itch signals. Calamine acts as a mild astringent and protective agent, which soothes irritated skin, reduces minor inflammation, and dries oozing or weeping skin lesions. The combination provides symptomatic relief from itching and discomfort.

• Absorption:
  Minimal systemic absorption through intact skin; increased absorption possible through damaged skin.
• Distribution:
  Primarily localized to the site of application.
• Metabolism:
  Metabolized locally or minimally absorbed systemically; pramoxine is metabolized via hepatic pathways when absorbed.
• Excretion:
  Excreted mainly in urine following systemic absorption.
• Onset:
  Symptomatic relief typically occurs within minutes after topical application.
• Half-life:
  Not well defined due to minimal systemic absorption.

• Pregnancy:
  Category C. Limited data on topical use; generally considered safe when used as directed but avoid prolonged or widespread application.
• Lactation:
  Minimal systemic absorption; considered compatible with breastfeeding. Avoid application on the breast area.

• Topical anesthetic (Pramoxine hydrochloride)
• Skin protectant / Astringent (Calamine)

• Known hypersensitivity to pramoxine hydrochloride, calamine, or any formulation components.
• Open wounds or severe skin damage (due to risk of systemic absorption).
• Use contraindicated if history of allergic reactions to local anesthetics.

• Avoid application on large areas or broken skin to minimize systemic absorption.
• Discontinue use if irritation, rash, or allergic reaction develops.
• Use caution in patients with pre-existing skin conditions that may affect absorption.
• Not intended for use in mucous membranes, eyes, or genital areas.

• Common:
  Mild local irritation, burning, stinging, or redness at the application site.
• Rare:
  Allergic contact dermatitis, hypersensitivity reactions including rash, swelling, or anaphylaxis.
• Severity:
  Usually mild and transient; severe reactions require immediate discontinuation and medical attention.

• No significant drug interactions known due to minimal systemic absorption.
• Avoid concurrent use with other topical products containing anesthetics or irritants without medical advice.

• Continued recommendation as a safe and effective symptomatic treatment for pruritus and minor skin irritation.
• Emphasis on avoiding prolonged or extensive use to minimize risk of systemic absorption or sensitization.
• No major changes in approved indications or dosing recently.

• Store at 20°C to 25°C (68°F to 77°F).
• Protect from excessive heat and moisture.
• Keep container tightly closed.
• For external use only.