Calamine + Allantoin + Vitamin E Lotion
Calamine IP 10% w/v + Allantoin IP 0.5% w/v + Vitamin E (d-alpha-Tocopherol) 0.5% w/v Lotion · Dermatology, Skin Care, General Wellness
LOTION PRESENTATION:
Product Profile
Calamine + Allantoin + Vitamin E Lotion is a proven, multi-action soothing topical lotion combining the cooling protective properties of calamine, the skin-repair stimulating effect of allantoin, and the antioxidant emollient action of Vitamin E. As a premier WHO-GMP certified pharmaceutical manufacturer in Baddi, Saar Biotech manufactures this lotion using controlled mineral dispersion homogenization, ensuring stable calamine suspension and consistent fill volume in every 60ml and 100ml bottle.
DCGI Approved
Comprehensive documentation and CDSCO support for rapid market entry in India.
Fast Turnaround
30-45 days lead time for new batches with state-of-the-art logistics.
Pan-India Supply & Contract Manufacturing
Clinical Overview & Therapeutic Class
Calamine + Allantoin + Vitamin E Lotion belongs to the Lotions and External Preparations category within the Dermatology and Skin Care therapeutic segments. It occupies a commercially important position — bridging the gap between clinical dermatology and consumer skin-care — as a prescription-adjacent OTC product that dermatologists, paediatricians, and general physicians confidently recommend for a wide range of common skin irritation presentations.
Calamine IP 10% w/v — the primary active — provides instant cooling astringent relief through its zinc oxide and ferric oxide composition. Allantoin IP 0.5% w/v adds keratolytic and wound-healing properties that support faster recovery of irritated skin. Vitamin E (d-alpha-Tocopherol) 0.5% w/v contributes emollient antioxidant protection and barrier support for damaged skin.
Saar Biotech manufactures this formulation at our Baddi manufacturing facility, supplying B2B third-party manufacturing partners across India’s dermatology, paediatric, and consumer health segments in 60ml and 100ml pack formats.
Pan-India Supply & Contract Manufacturing
The Saar Biotech Advantage
At Saar Biotech, we manufacture Calamine + Allantoin + Vitamin E Lotion using a controlled mineral dispersion process that ensures calamine remains uniformly suspended in the lotion base, delivering consistent active delivery from the first pour to the last drop in the bottle.
- Calamine Suspension Stability: Calamine is an insoluble mineral powder that tends to settle in aqueous lotion systems on standing. Our validated mixing sequence, particle size control, and carefully selected suspending agents maintain a readily re-dispersible, easily pourable calamine suspension — ensuring every application delivers the full 10% calamine concentration.
- Vitamin E Homogenization: Vitamin E (tocopherol) is a fat-soluble antioxidant that requires proper emulsification into the aqueous lotion base to prevent phase separation or creaming on storage. Our controlled temperature homogenization ensures stable, uniform Vitamin E distribution throughout the lotion.
- Tropical Climate Stability: The calamine lotion is formulated and stability-tested for long-term thermal stability under Indian tropical storage conditions (up to 40°C/75% RH accelerated testing) to ensure shelf-life performance in the Indian pharmaceutical supply chain.
- Flexible Pack Configurations: Our filling lines support 60ml and 100ml bottles in with-carton, without-carton, shrink-packed, and outer-configured formats — giving B2B brands flexibility for retail, institutional, and hospital supply chain requirements.
Pan-India Supply & Contract Manufacturing
Key Indications & Usage
Calamine + Allantoin + Vitamin E Lotion is manufactured and supplied by Saar Biotech for the following approved topical applications:
- Prickly Heat (Miliaria Rubra): Immediate cooling and pruritus relief for heat rash — particularly relevant in the Indian summer market where prickly heat is one of the highest-volume OTC dermatology conditions
- Minor Insect Bites & Stings: Rapid reduction of local itching, redness, and wheal formation from mosquito and minor insect bites
- Contact Dermatitis: Topical soothing management of skin redness, dryness, and pruritus from contact allergic or irritant reactions
- Post-Sun Exposure Skin Care: Calamine’s cooling and protective mineral film soothes sun-exposed or mildly sunburned skin; Vitamin E provides antioxidant protection against UV-generated free radical damage
- Dry, Irritated, or Sensitive Skin: Allantoin and Vitamin E together provide emollient and repair support for chronically dry or mildly eczematous skin conditions
Pan-India Supply & Contract Manufacturing
Mechanism of Action & Manufacturing Integrity
Clinical Mechanism of Action
Calamine (10%) — zinc oxide in calamine acts via multiple mechanisms: (1) Mild protein precipitation (astringent action) tightens loose and inflamed skin, reducing permeability and weeping; (2) Zinc ions inhibit the growth of skin surface organisms, providing mild antiseptic protection; (3) Physical barrier formation: the dried calamine film physically reduces contact between irritated skin and environmental triggers; (4) Evaporative cooling: as the aqueous lotion vehicle evaporates from the skin surface, it extracts heat — producing the characteristic cooling sensation that immediately reduces itch and burning.
Allantoin (0.5%) stimulates fibroblast proliferation and keratinocyte differentiation, accelerating re-epithelialization of irritated or mildly damaged skin. It also acts as a keratolytic — softening and removing damaged corneocytes from the stratum corneum to facilitate the underlying healing response.
Vitamin E (0.5%) functions as a free-radical scavenger in the lipid bilayers of cell membranes, neutralizing reactive oxygen species generated by UV radiation, environmental pollutants, and inflammatory processes. Topically, it reduces TEWL and provides emollient moisture retention for dry, barrier-impaired skin.
Manufacturing Integrity
- Calamine Particle Size Control: Calamine API is milled to a defined particle size range before incorporation, ensuring consistent powder fineness for optimal suspension stability and smooth application feel.
- Stability-Tested pH: The lotion base pH is maintained within the range that optimizes calamine suspension stability and Allantoin solubility, while remaining within the safe cutaneous pH range for all skin types.
Pan-India Supply & Contract Manufacturing
B2B & Contract Manufacturing Details
Saar Biotech provides Third-Party Manufacturing and Contract Manufacturing for Calamine + Allantoin + Vitamin E Lotion from our liquid and topical manufacturing facility in Baddi, Himachal Pradesh.
- Facility: Liquid/suspension manufacturing block with controlled mixing vessels, homogenizer, automated bottle filling, and capping/labelling lines.
- Packaging: 60ml and 100ml HDPE/PET bottles — with/without carton, sticker label, shrink pack, outer configurations 72x100ml and 100x100ml.
- MOQ: 5,000 to 2,00,000+ units per batch.
- Turnaround: New orders — 30–45 working days; Repeat orders — 20–25 working days.
- Documentation: Full COA, batch manufacturing record, and stability data on request.
Pan-India Supply & Contract Manufacturing
Quality Control & Compliance
Every commercial batch of Calamine + Allantoin + Vitamin E Lotion is released only after passing the following analytical protocol:
| Test | Method | Acceptance |
|---|---|---|
| Calamine / Zinc Content Assay | Volumetric / AAS per IP | 95–105% of label claim |
| Vitamin E Assay | HPLC vs. reference standard | 90–110% of label claim |
| Allantoin Identity | UV/IR as per IP | Conforms |
| pH | pH meter (25°C) | Within specification |
| Viscosity / Pourability | Visually — freely pourable on shaking | Conforms |
| Calamine Suspension | Uniformity on shaking — no hard cake | Conforms |
| Microbial Limit Test | IP method (topical) | Within IP limit |
| Net Fill Volume | Gravimetric per bottle | Within ±3% |
| Certificate of Analysis | GLP-signed COA | Issued with every batch |
For B2B manufacturing enquiries, contract pricing, or complete product dossier for Calamine + Allantoin + Vitamin E Lotion, please use the enquiry form below.
Pan-India Supply & Contract Manufacturing
Clinical Q&A for Calamine + Allantoin + Vitamin E Lotion
Technical data on bioavailability, pediatric dosing protocols, and therapeutic efficacy for healthcare professionals.
What are the clinical and OTC indications for Calamine + Allantoin + Vitamin E Lotion?
How does each component contribute to the therapeutic action of this lotion?
What is the recommended application frequency and method?
Are there any contraindications or precautions with this lotion?
What are the expected outcomes and is there a risk of skin staining?
B2B Manufacturing Guide for Calamine + Allantoin + Vitamin E Lotion
Detailed insights on MOQs, lead times, and regulatory support for contractmanufacturing partners.