ENCHANTMENT HAND SANITIZER- alcohol gel 
SOMBRA COSMETICS

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

----------

Enchantment Hand Sanitizer

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.

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

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

Enchantment 2g gel

ENCHANTMENT HAND SANITIZER 
alcohol gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:61577-1119
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL65 mL  in 100 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
GLYCERIN (UNII: PDC6A3C0OX)  
ISOPROPYL ALCOHOL (UNII: ND2M416302)  
LEMON PEEL (UNII: 72O054U628)  
ORANGE OIL (UNII: AKN3KSD11B)  
AMMONIUM ACRYLOYLDIMETHYLTAURATE, DIMETHYLACRYLAMIDE, LAURYL METHACRYLATE AND LAURETH-4 METHACRYLATE COPOLYMER, TRIMETHYLOLPROPANE TRIACRYLATE CROSSLINKED (45000 MPA.S) (UNII: Q7UI015FF9)  
ROSA DAMASCENA FLOWER (UNII: JWB78P295A)  
WITCH HAZEL (UNII: 101I4J0U34)  
YUCCA SCHIDIGERA STEM (UNII: N59C6T6D72)  
FILIPENDULA ULMARIA WHOLE (UNII: 3LH0M209LN)  
GREEN TEA LEAF (UNII: W2ZU1RY8B0)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:61577-1119-22 mL in 1 PACKET; Type 0: Not a Combination Product07/29/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A07/29/2020
Labeler - SOMBRA COSMETICS (097464309)
Establishment
NameAddressID/FEIBusiness Operations
SOMBRA COSMETICS097464309manufacture(61577-1119)

Revised: 11/2020
Document Id: b378de24-21db-36c5-e053-2995a90a5fe4
Set id: 63c647a8-9b35-4c0d-8797-c7ce94b87370
Version: 2
Effective Time: 20201106
 
SOMBRA COSMETICS