FDA.reportPublic FDA data

LOEWS HOTELS Ethyl Alcohol Antiseptic Hand Sanitizer GEL

Manufacturer
Carretta USA, Inc
Effective date
2024-12-31
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-06-01 00:49:35

Label at a glance#

ProductLOEWS HOTELS Antiseptic Hand Sanitizer
Active ingredientALCOHOL
Label structure9 sections

Dosage and administration

• wet hands thoroughly with product and allow to dry without wiping • for children under 6 years of age , use only under adult supervision

Storage and handling

• store at 20°C to 25°C (68° to 77°F) • may discolor fabrics

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Ethyl alcohol 75% v/v

Purpose

OTC - PURPOSE SECTION

Antiseptic

Use

INDICATIONS & USAGE SECTION

for hand sanitizing to decrease bacteria on the skin

Warnings

WARNINGS SECTION

Flammable, keep away from fire or flame
For external use only

Do not use • in the eyes. In case of contact with eyes, flush thoroughly with water • in children under 2 years of age

When using this product • avoid contact with broken skin • do not inhale or ingest

Stop use and ask a doctor if • skin irritation and redness develop • condition persists for more than 72 hours

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

• wet hands thoroughly with product and allow to dry without wiping • for children under 6 years of age , use only under adult supervision

Other information

STORAGE AND HANDLING SECTION

• store at 20°C to 25°C (68° to 77°F) • may discolor fabrics

Inactive ingredients

INACTIVE INGREDIENT SECTION

Aloe Extract, Arginine, Carbomer 940, Water

SPL UNCLASSIFIED SECTION

Distributed by: Carretta USA, Inc.,
16 Rutherford Rd. Unit 246, Allamuchy, NJ 07820

Made in China

Peel corner for full Drug Facts label

You may report serious side effects to
Carretta USA,Inc., 16 Rutherford Rd. Unit 246,Allamuchy, NJ 07820

Packaging

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

HandSanitizer-222HandSanitizer-222

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
1681bc73-b05f-12c3-1075-382ae39f449cProduct name120140508

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
78828-222LOEWS HOTELS ANTISEPTIC HAND SANITIZER (ETHYL ALCOHOL) GEL [CARRETTA USA, INC]3Unmatched20250101_1b6a187d-1531-4785-b0b6-0366dd7c8fbf.zip

Products#

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

DailyMed product names page 1 of 1 · 7 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
78828-22278828-222-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 5 matching rows.

Name, UNII, Kind table
NameUNIIKind
ALCOHOL3K9958V90MACTIB
ALOEV5VD430YW9IACT
ARGININE94ZLA3W45FIACT
CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED)4Q93RCW27EIACT
WATER059QF0KO0RIACT

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
08df9154-c11a-400f-9bf5-6bbe449001841b6a187d-1531-4785-b0b6-0366dd7c8fbf2024-12-31WarningsExact identifier
spl id: 08df9154-c11a-400f-9bf5-6bbe44900184
spl set id: 1b6a187d-1531-4785-b0b6-0366dd7c8fbf

Reported adverse events (FAERS/openFDA)#

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