FDA.reportPublic FDA data

ENCHANTMENT HAND SANITIZER

Manufacturer
SOMBRA COSMETICS
Effective date
2020-11-06
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 23:33:09

Label at a glance#

ProductENCHANTMENT HAND SANITIZER
Active ingredientALCOHOL
Label structure12 sections

Indications and uses

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

Dosage and administration

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 and handling

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

Label contents#

Full prescribing information#

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Alcohol 65%

Uses

INDICATIONS & USAGE SECTION

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

Warnings

WARNINGS SECTION

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

Do not use

OTC - DO NOT USE SECTION

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

When Using

OTC - WHEN USING SECTION

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 SECTION

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 SECTION

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

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

STORAGE AND HANDLING SECTION

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

Inactive ingredients

INACTIVE INGREDIENT SECTION

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

OTC - PURPOSE SECTION

Antiseptic

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Enchantment 2g gelEnchantment 2g gel

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
902574ethanol 65 % Topical GelPSN2
902574ethanol 0.65 ML/ML Topical GelSCD2
902574ethyl alcohol 65 % Topical GelSY2

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
61577-1119-22024-01-30C16284748780-11030e365-4b52-111a-e063-dadaa90a10e2Enchantment Hand Sanitizer

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
61577-1119-2ENCHANTMENT HAND SANITIZER2 mL in 1 PACKETGEL22

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
61577-1119ENCHANTMENT HAND SANITIZER (ALCOHOL) GEL [SOMBRA COSMETICS]2Legacy NDC, 1 package rows20201107_63c647a8-9b35-4c0d-8797-c7ce94b87370.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 14 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
61577-111961577-1119-2

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 13 matching rows.

Name, UNII, Kind table
NameUNIIKind
WATER059QF0KO0RIACT
GLYCERINPDC6A3C0OXIACT
ISOPROPYL ALCOHOLND2M416302IACT
LEMON PEEL72O054U628IACT
ORANGE OILAKN3KSD11BIACT
AMMONIUM ACRYLOYLDIMETHYLTAURATE, DIMETHYLACRYLAMIDE, LAURYL METHACRYLATE AND LAURETH-4 METHACRYLATE COPOLYMER, TRIMETHYLOLPROPANE TRIACRYLATE CROSSLINKED (45000 MPA.S)Q7UI015FF9IACT
ROSA DAMASCENA FLOWERJWB78P295AIACT
WITCH HAZEL101I4J0U34IACT
YUCCA SCHIDIGERA STEMN59C6T6D72IACT
FILIPENDULA ULMARIA WHOLE3LH0M209LNIACT
GREEN TEA LEAFW2ZU1RY8B0IACT
ALOE VERA LEAFZY81Z83H0XIACT
ALCOHOL3K9958V90MACTIB

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
b378de24-21db-36c5-e053-2995a90a5fe463c647a8-9b35-4c0d-8797-c7ce94b873702020-11-06WarningsExact identifier
spl id: b378de24-21db-36c5-e053-2995a90a5fe4
spl set id: 63c647a8-9b35-4c0d-8797-c7ce94b87370

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.