FDA.reportPublic FDA data

Hand Sanitizer Aloe Vera and Vitamin E

Manufacturer
AMENI GROUP S A S
Effective date
2021-09-16
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
legacy-cache
Hydrated at
2026-08-01 22:35:30

Label at a glance#

ProductHand Sanitizer Aloe Vera and Vitamin E
Active ingredientALCOHOL
Label structure10 sections

Indications and uses

For hand washing to drecrease bacteria on the skin. Recommended for repeated use.

Dosage and administration

Apply the necessary amount to the palms of your hands and rub them together until the product dries. If the dirt is too much, apply the necessary amount to remove it.

Label contents#

Full prescribing information#

Active Ingredient:

OTC - ACTIVE INGREDIENT SECTION

Ethyl Alcohol 70%

OTC - PURPOSE SECTION

Antimicrobial

Uses:

INDICATIONS & USAGE SECTION

For hand washing to drecrease bacteria on the skin. Recommended for repeated use.

Warnings:

WARNINGS SECTION

For external use only. Flammable, keep away from heat and flame.

Do not use

OTC - DO NOT USE SECTION

In the eyes, in case of contact, rinse eyes thoroughly with water.

Stop Use and ask a Doctor if

OTC - STOP USE SECTION

Irritacion and redness develop and persist for more than 72 hours.

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If swallowed, get medical help or contact a poison control center right away.

Directions:

DOSAGE & ADMINISTRATION SECTION

Apply the necessary amount to the palms of your hands and rub them together until the product dries. If the dirt is too much, apply the necessary amount to remove it.

Other Information:

SPL UNCLASSIFIED SECTION

Store at 20°C to 25°C (68 to 77f)
May discolor certain fabrics

Inactive Ingredients:

INACTIVE INGREDIENT SECTION

Water (Aqua), Alcohol, Glycerin, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Triethanolamine, Parfum (Fragrance), Aloe Barbadensis Leaf Extract, Avena Sativa Kernel Extract, PEG-40 Hydrogenated Castor Oil, Tocopherol Acetate.

Package Labeling: 74816-001-60

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LabelLabel

Package Labeling: 74816-001-30

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Label2Label2

Package Labeling: 74816-001-50

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Label3Label3

Package Labeling: 74816-001-10

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Label4Label4

Products#

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

DailyMed product names page 1 of 1 · 10 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
74816-00174816-001-60, 74816-001-30, 74816-001-50, 74816-001-10

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 9 matching rows.

Name, UNII, Kind table
NameUNIIKind
WATER059QF0KO0RIACT
GLYCERINPDC6A3C0OXIACT
CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED)59TL3WG5COIACT
TROLAMINE9O3K93S3TKIACT
ALOE VERA LEAFZY81Z83H0XIACT
OATZ6J799EAJKIACT
POLYOXYL 40 HYDROGENATED CASTOR OIL7YC686GQ8FIACT
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0IACT
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
cc1f7b77-0d06-885a-e053-2a95a90a9ef4bb5fbdbe-58ee-4f22-8200-42420271ea902021-09-16WarningsExact identifier
spl id: cc1f7b77-0d06-885a-e053-2a95a90a9ef4
spl set id: bb5fbdbe-58ee-4f22-8200-42420271ea90

Reported adverse events (FAERS/openFDA)#

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