Lather Hand Sanitizer
FDA Label NDC 61577-1114

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 Lather Hand Sanitizer (NDC 61577-1114). 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, uses, warnings, do not use, when using, otc - stop use, otc - keep out of reach of children, directions, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Active Ingredients

Ethyl Alcohol 65%

Uses

To decrease bacteria and viruses on the skin that could cause disease.  Recommended for repeated use, when hand washing is not available.

Warnings

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

Do Not Use

When using this product, do not use in or near the eyes. In case of contact, rinse eyes thoroughly with water.

When Using

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

Otc - Stop Use

Stop use and ask a doctor if irritation and redness develop. Condition persists more than 72  hours.

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.  For children under 6, use only under adult supervision.  Not recommended for infants.

Directions

Wet hands thoroughly and allow to dry without wiping.

Other Information

Do not store above 105F.  May discolor some fabrics.  Harmful to wood finishes and plastics.

Inactive Ingredients

glycerin, purified water, isopropyl alcohol, polyacrylate crosspolymer-6, rosa damascena flower water, hamamelis virginiana (witch hazel) leaf extract, aloe barbadensis leaf juice, citrus aurantium dulcis (orange) peel oil, yucca schidigera stem extract, filipendula rubra extract, camellia sinensis (green tea) leaf extract.

Purpose

Antiseptic

Package Label.Principal Display Panel

Los Poblanos 8oz Gel (Lather10ozgel)

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