ALOE VERA CENTER HAND SANITIZER- alcohol gel

ALOE VERA CENTER HAND SANITIZER by

Drug Labeling and Warnings

ALOE VERA CENTER HAND SANITIZER by is a Otc medication manufactured, distributed, or labeled by SOMBRA COSMETICS. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

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

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 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

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

ALOE VERA CENTER HAND SANITIZER 
alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 61577-1113
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	65 mL  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 61577-1113-8	236 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	06/15/2020
2	NDC: 61577-1113-4	118 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	06/15/2020
3	NDC: 61577-1113-2	54 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	06/15/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	06/01/2020

Labeler - SOMBRA COSMETICS (097464309)

Establishment
Name	Address	ID/FEI	Business Operations
SOMBRA COSMETICS		097464309	manufacture(61577-1113)