Alcohol Based Hand Sanitizer
FDA Label NDC 78539-001

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Seattle Sanitizer Llc for the product Alcohol Based Hand Sanitizer (NDC 78539-001). 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 drug facts, active ingredient(s), purpose, use(s), warnings, otc - keep out of reach of children, directions, other information, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

→ Drug Facts

→ Active Ingredient(s)

→ Purpose

→ Use(s)

→ Warnings

→ Otc - Keep Out Of Reach Of Children

→ Directions

→ Other Information

→ Packaging

Drug Facts

Active Ingredient(S)

Ethyl Alcohol 85% v/v

Purpose

Antiseptic

Use(S)

Hand sanitizer to help reduce bacteria that potentially can cause disease. For use when soap and water are not available

Warnings

For external use only. Flammable. Keep away from heat or flame.

Do not use

• on children less than 2 months of age

• on open skin wounds

When using this product keep out of eyes, ears and mouth. In case of contact with eyes, rinse thoroughly with water.
Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition.

Otc - Keep Out Of Reach Of Children

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions

Place enough product on hands to cover all surfaces. Rub hands together until dry.
Supervise children under 6 years of age when using this product to avoid swallowing.