Active Ingredients
Ethyl Alcohol 65% v/v
Sombra Antibacterial Hand Sanitizer
FDA Label NDC 61577-4130
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 Antibacterial Hand Sanitizer (NDC 61577-4130). 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.
Label Section Quick Index
Uses
To decrease bacteria and viruses on the skin that could cause disease. Recommended for repeated use.
Warnings
For external use only: hands. Flammable, keep away from fire or flame.
Do Not Use
avoid contact with broken skin. Do not inhale or ingest. Children under 6, use only
under adult supervision. Not recommended for infants.
When Using
When using this product, keep out of the eyes. In case of contact with eyes, flush thoroughly with water.
Otc - Stop Use
Stop use if irritation and redness develop or if condition persists for more than 72 hours.
Otc - 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.
Storage And Handling
Do not store above 105 F. May discolor some fabrics and may harm wood finishes.
Inactive Ingredients
glycerin, purified water, isopropyl alcohol, aminomethyl propanol, citrus limon (lemon) peel oil, citrus aurantium dulcis (orange) peel oil, yucca schidigera stem extract, rosa damascena flower water, hamamelis virginiana (witch hazel) leaf extract, filipendula ulmaria (queen of the prairie) extract, camellia sinensis (green tea) leaf extract, aloe barbadensis leaf extract.
Purpose
Antiseptic
Package Label.Principal Display Panel
Sombra Economy Hand Sanitizer (Sombra8ozeconomy)
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