Enchantment Hand Sanitizer
FDA Label NDC 61577-1119

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 Enchantment Hand Sanitizer (NDC 61577-1119). 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

Alcohol 65%

Uses

Helps reduce bacteria on the skin that potentially can cause disease.  For use when soap and water are not available.

Warnings

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

Do Not Use

In children less than 2 months of age.  On open skin wounds

When Using

When using this product, keep out of eyes, ears and mouth.  In case of contact with eyes, rinse eyes thoroughly with water.

Otc - Stop Use

Stop use and ask a doctor if irritation or rash occurs. These may be signs of 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.

Storage

Store between 15-30C (59-86F)
Avoid freezing and excessive heat above 40C (104F)

Inactive Ingredients

glycerin, purified water, isopropyl alcohol, polyacrylate crosspolymer-6, 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.

*organic

Purpose

Antiseptic

Package Label.Principal Display Panel

Enchantment 2g Gel (Supplyone2gpacket)

Enchantment 2g Gel (Supplyone2gpacket)

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