Soho Fresh Hand Sanitizer
FDA Label NDC 78533-000

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Essaar Inc. for the product Soho Fresh Hand Sanitizer (NDC 78533-000). 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 ingredients, purpose, use, warnings, when using this product, stop use and ask a doctor if, keep out of reach of children, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

→ Drug Facts

→ Active Ingredients

→ Purpose

→ Use

→ Warnings

→ When Using This Product

→ Stop Use And Ask A Doctor If

→ Keep Out Of Reach Of Children

→ Directions

→ Other Information

→ Inactive Ingredients

→ Package Labeling: 60ml

→ Package Labeling: 250ml

→ Package Labeling: 500ml

→ Package Labeling: 1000ml

Drug Facts

Active Ingredients

Ethyl alcohol 70%

Purpose

Antiseptic

Use

To decrease bacteria on the skin that could cause disease. Recommended for repeated use.

Warnings

For external use only: hands. Flammable, Keep away from fire of flame.

When Using This Product

Keep out of eyes. In case of contact with eyes, flush thoroughly with water. Avoid contact with broken skin. Do not inhale or ingest.

Stop Use And Ask A Doctor If

Irritation or redness develops. Condition persist for more than 72 hours.

Keep Out Of Reach Of Children

If swallowed, get medical help or contact a Poison Control Center right away.

Directions

Thoroughly cover your hands with product and allow to dry without wiping. Children under 6 years of age should be supervised when using this product. Not recommended for infants.