Bactakleen Hand Sanitizer
FDA Label NDC 73215-101

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Excelsia Technologies Sdn Bhd for the product Bactakleen Hand Sanitizer (NDC 73215-101). 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 active ingredients, purpose, keep out of reach of children, uses, warnings, dosage & administration, inactive ingredients, bactakleen hand sanitizer, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Active Ingredients

Benzalkonium chloride (0.1%)

Purpose

Antibacterial

Keep Out Of Reach Of Children

If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

Uses

Hand Sanitizer to help reduce bacteria on skin

Warnings

For external use only

Do not use if you are allergic to any of the ingredients

When using this product avoid contact with eyes. If contact occurs, rinse eyes thoroughly with water. avoid contact with broken skin

Stop use and ask a doctor if irritation or redness develops and condition persists for more than 72 hours

If pregnant or breast-feeding, ask a health professional before use.

Dosage & Administration

Place enough product in your palm to thoroughly spread on both hands and rub into the skin until dry.

Inactive Ingredients

Water. Aloe Barbadensis Leaf Juice, Lime (Citrus Aurantifolia) Juice, Tea Tree (Melaleuca Alternifolia) Leaf Oil.

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