Spai-sons
FDA Label NDC 66854-007

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Spai-sons Pharmaceutical International Cosmetics for the product Spai-sons (NDC 66854-007). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding otc - active ingredient, otc - purpose, otc - keep out of reach of children, indications & usage, warnings, dosage & administration, inactive ingredient, package label.principal display panel, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Otc - Active Ingredient

Biotin is a major component of the formulation acts to strengthen the hair follicle and prevents hair loss as well. It is nutrient for the hair root oxygenate the hair turn slowing the loss. Provides resilience and resistence to hair. Addition of biotin are other ingredient such as Asian Ginseng, Arginine, Zinc Gluconate, Niacinamide, Ornitine HCl, and Citrulline which help strengthen the hair follicle and produce a synergistic action on it.

Otc - Purpose

Prolac-vit is a well balanced formula that helps the function and nutrition of hair root, resulting in abundant hair and neutralizing alopecia caused by lack and certain components, mistreatment or toxic agents.

Otc - Keep Out Of Reach Of Children

This product must be keep out reach of children

Indications & Usage

This product is for topical application directly on the hair follicle.

Warnings

Avoid contact with eyes, if they do wash with water. If swallowed contact a physician immediately

Dosage & Administration

Recommended use: thin or fragile, ill-treated hair, malnourished scalp or hair roots, Alopecia, hair loss due to cycle change.

Directions: must be applied directly to the scalp and then massage very gently until the product is absorbed

Inactive Ingredient

This is a liquid prepared with the technology needed to provide the hair follicle absorption of the active ingredients, plus inactive ingredients contribute to the regeneration of the hair fiber by providing a strengthening therefore. No adverse effects were seen with the use of this product as inactive ingredients do not cause skin hypersensivity.

Package Label.Principal Display Panel

IMAGE OF CARTON LABEL

Image Of Carton Label (Prolac)

Image Of Carton Label (Prolac)

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