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.

Manufacturing Advantage

Why Saar Biotech for Calamine + Allantoin + Vitamin E Lotion?

Since 2005, Saar Biotech has been a distinguished WHO-GMP certified leader in pharmaceutical manufacturing. We utilize advanced micronization and pH-stabilization protocols to deliver unmatched bioavailability for this Calamine + Allantoin + Vitamin E Lotion formulation.

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

Batch Lead Time 30-45 Days (Domestic)
B2B Services Contract & Third-Party
Compliance DCGI & Schedule M Standards
Medical Intelligence

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?

Calamine + Allantoin + Vitamin E Lotion is indicated as a topical soothing preparation for a wide range of skin irritation conditions. Primary indications include prickly heat (miliaria rubra) — calamine’s cooling astringent action rapidly relieves the burning and pruritus of heat rash; minor insect bites and stings — calamine reduces the immediate wheal-and-flare inflammatory reaction; contact dermatitis and allergic rashes — the anti-inflammatory and soothing properties of all three components reduce redness, weeping, and itch; and dry, itchy, or irritated skin from environmental exposure or post-sun exposure. The allantoin component supports wound healing of minor abrasions, while Vitamin E provides emollient antioxidant protection. Final indications on the approved label must follow the licensed prescribing information.

How does each component contribute to the therapeutic action of this lotion?

Calamine IP (10%) is a mixture of zinc oxide (approximately 98%) and ferric oxide (approximately 0.5%) that imparts the characteristic pink colour and therapeutic properties. When applied to skin, calamine forms a light, evaporating film that produces a pleasant cooling sensation via water evaporation — providing immediate relief from itching and burning. Zinc oxide within calamine also provides mild antiseptic, astringent (protein-denaturing), and skin-protective properties that reduce the permeability of inflamed skin. Allantoin (0.5%) is a plant-derived (comfrey root) keratolytic and wound-healing agent that promotes the desquamation of necrotic tissue, stimulates cell proliferation, and reduces inflammation — accelerating recovery from minor skin irritation and abrasion. Vitamin E (d-alpha-Tocopherol, 0.5%) is the primary fat-soluble antioxidant in human skin, protecting cell membranes from oxidative damage by free radicals. As a lotion component, it provides emollient moisturization, reduces TEWL (transepidermal water loss), and supports the barrier function of irritated skin.

What is the recommended application frequency and method?

The lotion should be shaken well before each use, as calamine settles at the bottom of the bottle on standing. Apply liberally to the affected skin area two to four times daily, or as frequently as needed for symptom relief. The lotion is applied by pouring onto a cotton pad or clean cloth and gently dabbing onto the affected area — avoid vigorous rubbing on acutely inflamed or weeping skin. Allow to dry before dressing. For prickly heat, application after cooling shower and before sleep is particularly effective. The lotion should not be applied to deep wounds, eyes, or mucous membranes.

Are there any contraindications or precautions with this lotion?

Calamine + Allantoin + Vitamin E Lotion is generally well-tolerated with an excellent safety profile. It is contraindicated only in patients with known hypersensitivity to zinc oxide, calamine, allantoin, or Vitamin E (tocopherol). It should not be applied to actively weeping, infected, or severely inflamed skin without physician guidance. While calamine is often used around the perioral region in children for diaper rash (as a zinc oxide-containing preparation), internal or mucosal contact must be avoided. The lotion should not be applied to broken skin in early pregnancy without physician direction, as Vitamin E topical preparations have variable safety data in that context.

What are the expected outcomes and is there a risk of skin staining?

Relief from itching and burning typically begins within 5–15 minutes of application as the lotion evaporates, leaving a protective zinc oxide film on the skin surface. Calamine’s characteristic pink colour will temporarily leave a light, pinkish residue on the skin — this is cosmetically acceptable on body areas but patients should be advised it may be visible on light clothing. The pinkish colour washes off with water and does not permanently stain skin. With consistent use over 3–5 days, most minor skin irritation conditions resolve significantly. Allantoin promotes faster epidermal regeneration, reducing the recovery time from heat rash and minor contact reactions.
Manufacturing Support

B2B Manufacturing Guide for Calamine + Allantoin + Vitamin E Lotion

Detailed insights on MOQs, lead times, and regulatory support for contractmanufacturing partners.

What pack sizes and packaging formats are available for Calamine + Allantoin + Vitamin E Lotion manufacturing?
Saar Biotech manufactures this lotion in 60ml and 100ml bottle formats, confirmed from our production packing records. Packaging configurations include with-carton and without-carton supply, sticker-label bottles, shrink-pack outer wrapping, and institutional outer configurations of 72x100ml and 100x100ml for hospital and institutional bulk supply channels. Custom printed cartons with brand embossing and premium outer finish options are available for pharmacy retail positioning.
What is the MOQ for Calamine Allantoin Vitamin E Lotion contract manufacturing?
Standard MOQ starts at 5,000 units per SKU for both 60ml and 100ml pack sizes. Dermatology and skin-care brands building a portfolio range can order both sizes concurrently, allowing them to address different market segments — 60ml for medical rep samples and trial packs, 100ml for retail pharmacy placement. Institutional and hospital supply channels often source the 100ml without-carton format in high volumes, which qualifies for bulk pricing.
What analytical tests are performed on every batch of this lotion?
Every commercial batch of Calamine + Allantoin + Vitamin E Lotion undergoes Assay for Calamine content (zinc determination by volumetric/atomic absorption method against IP standard), Vitamin E assay by HPLC against reference standard, and Allantoin identity test. Additional release tests include pH, viscosity, appearance (colour, pourability, calamine suspension uniformity on shaking), fill volume per bottle, Microbial Limit Testing (MLT) for topical preparations, and pack/cap integrity inspection. A complete GLP-signed Certificate of Analysis (COA) is provided with every B2B consignment.
Does Saar Biotech support brand name registration and DCGI licensing for topical skin lotion brands?
Yes. Our regulatory support team assists B2B brands with DCGI brand name search and product registration for topical dermatology lotions. We provide Schedule M-compliant artwork review, ensuring correct active ingredient declaration, net content labelling, external-use cautions, storage instructions, batch number format, and manufacturing unit address are accurately reflected on bottle label and carton before production authorization. For OTC-positioning of calamine lotion brands, we advise on appropriate claim wording to align with CDSCO guidelines.
What packaging and carton design services are available for private-label lotion brands?
Saar Biotech provides comprehensive private-label packaging support for lotion brands. Available options include HDPE or PET bottles with sticker labels or direct print, mono-cartons with gloss lamination or matte finish, drip-off brand embossed premium cartons, and shrink-wrapped cluster packs for retail shelf appeal. Outer shipper boxes with 72-bottle or 100-bottle per carton configurations are standard for institutional and wholesale supply. All artwork undergoes Schedule M compliance review before production authorization.
What is the manufacturing turnaround time for a new Calamine Allantoin Vitamin E Lotion order?
New third-party manufacturing orders are typically dispatched within 30 to 45 working days from artwork finalisation and raw material readiness at our Baddi facility. Because calamine suspension lotions require careful controlled mixing to achieve consistent pourability and calamine distribution, our liquid manufacturing protocol is validated before batch production is authorized. Repeat orders from established brand partners benefit from stored formulation and artwork records, with batches typically ready in 20 to 25 working days.
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