Sombra Hand Sanitzer
FDA Label NDC 61577-4129

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Sombra Cosmetics for the product Sombra Hand Sanitzer (NDC 61577-4129). 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 ingredient, purpose, uses, warnings, do not use, when using this product, stop use and ask a doctor, 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

Active Ingredient

Ethyl Alcohol 65%

Purpose

Antiseptic

Uses

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

Warnings

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

Do Not Use

Stop use and ask doctor if, irritation and redness develop condition persists for more than 72 hours.

When Using This Product

When using this product, keep out of the 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

Stop use and ask doctor if, irritation and redness develop condition persists 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

Wet hands thoroughly with product and allow to dry without wiping.  For children under 6, use only under adult supervision.  Not recommended for infants.

Other Information

Do not store above 105F.  May discolor some fabrics.  May harm wood finishes.

Inactive Ingredients

Aloe Barbadensis leaf juice, Citrus Aurantium Dulce (orange) Peel Oil, Glycerin, Isopropyl Alcohol, Purified Water, Rosa Damascena Flower Water, Hamemelis Viginiara Leaf Extract, Yucca Schidigera Root Extract.

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