ALOE VERA CENTER 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.

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Aloe Vera Center Hand Sanitizer

Active Ingredients

Ethyl Alcohol 65%

Uses

Helps reduce bacteria on the skin that could cause diseases.

Warnings

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

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

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

Stop use and ask a doctor if irritation or rash appears and lasts.

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

Directions

Place enough product in the palm of your hands to thoroughly cover your hands. Rub hands together briskly until product is completely absorbed and hands are dry.

Other information

Store between 15-30C (59-86F)
Avoid freezing and excessive heat above 40C (105F)

Inactive ingredients

glycerin, aloe barbadensis leaf extract, camellia sinensis (green tea) leaf extract, purified water, isopropyl alcohol, polyacrylate crosspolymer-6, rosa damascena flower water, hamamelis virginiana (witch hazel) leaf extract, citrus aurantium dulcis (orange) peel oil, filipendula ulmaria (queen of the prairie) extract, yucca schidigera root extract

Purpose

Antiseptic, Hand Sanitizer

Aloe Vera 8oz gel

ALOE VERA CENTER HAND SANITIZER 
alcohol gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:61577-1113
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)  
ROSA DAMASCENA FLOWER (UNII: JWB78P295A)  
WITCH HAZEL (UNII: 101I4J0U34)  
ORANGE OIL (UNII: AKN3KSD11B)  
CAMELLIA SINENSIS FLOWER (UNII: 9I2BJY2J17)  
FILIPENDULA ULMARIA WHOLE (UNII: 3LH0M209LN)  
AMMONIUM ACRYLOYLDIMETHYLTAURATE, DIMETHYLACRYLAMIDE, LAURYL METHACRYLATE AND LAURETH-4 METHACRYLATE COPOLYMER, TRIMETHYLOLPROPANE TRIACRYLATE CROSSLINKED (45000 MPA.S) (UNII: Q7UI015FF9)  
YUCCA SCHIDIGERA STEM (UNII: N59C6T6D72)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:61577-1113-8236 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product06/15/2020
2NDC:61577-1113-4118 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product06/15/2020
3NDC:61577-1113-254 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product06/15/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A06/01/2020
Labeler - SOMBRA COSMETICS (097464309)
Establishment
NameAddressID/FEIBusiness Operations
SOMBRA COSMETICS097464309manufacture(61577-1113)

Revised: 7/2020
Document Id: ab223010-c726-7b75-e053-2a95a90acf14
Set id: 769d67c5-3936-40e9-a5be-c3de7ea5a336
Version: 2
Effective Time: 20200723
 
SOMBRA COSMETICS