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Doxepine HCL Cream 5% w/w

Doxepin HCL Cream 5% w/w is a topical formulation used for the short-term relief of moderate to severe pruritus (itching) associated with eczematous conditions. Doxepin, a tricyclic compound, exerts potent antipruritic and antihistaminic activity when applied locally to the skin. It is particularly effective in managing atopic dermatitis, contact dermatitis, and lichen simplex chronicus.

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Description

Indications:

  • Atopic dermatitis
  • Contact dermatitis (allergic and irritant)
  • Lichen simplex chronicus
  • Pruritus of dermatological origin
  • Eczematous skin conditions with persistent itching

Mechanism of Action:

Topically applied doxepin blocks histamine H1 and H2 receptors in the skin, resulting in effective relief from itching. Though originally developed as a tricyclic antidepressant, its antihistaminic potency makes it a powerful agent for dermatological pruritus, providing both immediate and sustained itch relief without systemic effects when used appropriately.

Key Benefits:

  • Strong antipruritic effect for chronic or treatment-resistant itching
  • Rapid onset of action, often within 2–3 days of use
  • Reduces skin inflammation and scratching-related damage
  • Non-systemic delivery with minimal absorption when used as directed
  • Especially useful in nighttime itching and improving sleep

Dosage & Administration:

Apply a thin film of the cream to the affected area(s) four times daily or as directed by a physician. Do not exceed recommended frequency to minimize the risk of drowsiness or systemic side effects. The treated area should not be occluded with dressings unless prescribed.

Precautions & Warnings:

  • For external use only
  • Avoid contact with eyes, mouth, or mucous membranes
  • May cause drowsiness if absorbed systemically—limit application area and frequency
  • Not recommended for use in children under 12 years
  • Use with caution in elderly patients and those with hepatic impairment
  • Avoid alcohol and CNS depressants during use

Side Effects:

Most common side effects are localized and may include:

  • Mild burning or stinging sensation
  • Redness or irritation at the application site
  • Drowsiness (especially with overuse or large area application)
  • Dry skin or contact dermatitis (rare)

If signs of hypersensitivity or excessive sedation occur, discontinue use and consult a physician.

Storage:

Store below 25°C in a cool, dry place. Do not freeze. Keep the tube tightly closed when not in use and out of reach of children.

Export & Contract Manufacturing

We offer Doxepin HCL Cream 5% w/w for international markets with full regulatory and technical documentation support, including COA, MSDS, and country-specific dossiers. Manufactured in WHO-GMP certified facilities, our product meets stringent global standards for safety, quality, and efficacy. We currently export to clients across Latin America, Asia, Africa, the Middle East, and the CIS region with flexible logistics and efficient order fulfillment.

Third-Party & Private Label Manufacturing

We provide turnkey third-party and private label manufacturing services for Doxepin Cream 5% w/w in 45g laminated tubes. Clients can customize packaging, branding, and labeling to suit their target markets. Our in-house design and compliance teams assist in developing compliant, market-ready products. Whether launching a new dermatology range or expanding an existing one, we offer scalable manufacturing with full confidentiality and on-time delivery.

Leading Manufacturer and Exporter of Pharmaceuticals Across Continents

Aetos Life Care is a trusted manufacturer and exporter of high-quality generic and specialty medicines, serving over 40 countries across Latin America, Africa, Asia, Europe, and the CIS region. We have a strong presence in key markets, including Iraq, Jordan, Saudi Arabia, UAE, Ukraine, Kazakhstan, Venezuela, Ecuador, and more. Backed by 15 WHO-GMP accredited facilities designed to meet EU-GMP standards, we ensure the highest quality, safety, and compliance in every product we deliver.

Iraq, Jordan, Riyadh (Saudi Arabia), Dubai (UAE)

Ukraine, Kazakhstan, Turkmenistan, Tajikistan

Venezuela, Ecuador, Peru, Paraguay, Panama, Costa Rica, El Salvador

Cameroon, South Sudan, Angola

Myanmar