FDA.reportPublic FDA data

antibacterial hand sanitizer gel

Manufacturer
Cosmuses Cosmetics (Ningbo) Co., Ltd.
Effective date
2024-05-30
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 00:13:07

Label at a glance#

Productantibacterial hand sanitizer gel 01
Active ingredientALCOHOL
Label structure11 sections

Indications and uses

For hand Sanitizing

Dosage and administration

Wet hands throughly with product and allow to dry without wiping. For children under 6 age use only under adult supervision. Not recommended for infants.

Storage and handling

Other information ​ Do not store above 105 o F. May discolor some fabrics.

Label contents#

Full prescribing information#

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Alcohol 62%

Purpose

OTC - PURPOSE SECTION

Antiseptic

Uses

INDICATIONS & USAGE SECTION

  • For hand Sanitizing

Warnings

WARNINGS SECTION

For external use only- hands.

Flammable. Keep away from heat and flame.

OTC - WHEN USING SECTION

When using this product, keep out of eyes. In case of contact with eyes, flush thoroughly with water. Avoid contact with broken skin. Do not inhale or ingest.

OTC - STOP USE SECTION

Stop use and ask doctor if skin irritation develops.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

Directions

DOSAGE & ADMINISTRATION SECTION

  • Wet hands throughly with product and allow to dry without wiping.
  • For children under 6 age use only under adult supervision.
  • Not recommended for infants.

STORAGE AND HANDLING SECTION

Other information ​

  • Do not store above 105 oF.
  • May discolor some fabrics.

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Aqua, Glycerin, Propylene Glycol, Aloe Barbadensis Leaf Extract, Carbomer, Triethanolamine, Tocopheryl Acetate, Fragrance, PEG-40 Hydrogenated Castor Oil.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

82953-01682953-016

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
581660ethanol 62 % Topical GelPSN1
581660ethanol 0.62 ML/ML Topical GelSCD1
581660ethanol 62 % Topical GelSY1

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
82953-016-01antibacterial hand sanitizer gel0115 mL in 1 BOTTLE, PLASTICGEL151
82953-016-02antibacterial hand sanitizer gel0130 mL in 1 BOTTLE, PLASTICGEL301
82953-016-03antibacterial hand sanitizer gel0160 mL in 1 BOTTLE, PLASTICGEL601
82953-016-04antibacterial hand sanitizer gel0175 mL in 1 BOTTLE, PLASTICGEL751
82953-016-05antibacterial hand sanitizer gel0135 mL in 1 BOTTLE, PLASTICGEL351
82953-016-06antibacterial hand sanitizer gel0150 mL in 1 BOTTLE, PLASTICGEL501
82953-016-07antibacterial hand sanitizer gel01120 mL in 1 BOTTLE, PLASTICGEL1201
82953-016-08antibacterial hand sanitizer gel01240 mL in 1 BOTTLE, PLASTICGEL2401
82953-016-09antibacterial hand sanitizer gel01300 mL in 1 BOTTLE, PLASTICGEL3001
82953-016-10antibacterial hand sanitizer gel0190 mL in 1 BOTTLE, PLASTICGEL901

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
82953-016ANTIBACTERIAL HAND SANITIZER GEL 01 (ALCOHOL) GEL [COSMUSES COSMETICS (NINGBO) CO., LTD.]1Current NDC, 10 package rows20240531_19a7b2fc-239c-b53c-e063-6394a90a0906.zip

Products#

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

DailyMed product names page 1 of 1 · 11 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
82953-01682953-016-02, 82953-016-05, 82953-016-03, 82953-016-06, 82953-016-07, 82953-016-04, 82953-016-08, 82953-016-01, 82953-016-09, 82953-016-10

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 10 matching rows.

Name, UNII, Kind table
NameUNIIKind
FRAGRANCE 135765EM498GW35IACT
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0IACT
GLYCERINPDC6A3C0OXIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
ALOE VERA LEAFZY81Z83H0XIACT
WATER059QF0KO0RIACT
CARBOMER 9404Q93RCW27EIACT
TROLAMINE9O3K93S3TKIACT
ALCOHOL3K9958V90MACTIB
POLYOXYL 40 HYDROGENATED CASTOR OIL7YC686GQ8FIACT

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
antibacterial hand sanitizer gel 01ALCOHOLCosmuses Cosmetics (Ningbo) Co., Ltd.19a7b2fc-239c-b53c-e063-6394a90a09062024-05-30WarningsExact identifier
ndc (package): 82953-016-03
ndc (package): 82953-016-01
ndc (package): 82953-016-08
ndc (package): 82953-016-04
ndc (package): 82953-016-06
ndc (package): 82953-016-05
ndc (package): 82953-016-07
ndc (package): 82953-016-09
ndc (package): 82953-016-10
ndc (package): 82953-016-02
ndc (product): 82953-016
ndc11 (package): 82953001602
ndc11 (package): 82953001603
ndc11 (package): 82953001610
ndc11 (package): 82953001609
ndc11 (package): 82953001608
ndc11 (package): 82953001601
ndc11 (package): 82953001607
ndc11 (package): 82953001604
ndc11 (package): 82953001606
ndc11 (package): 82953001605
spl id: 19a7b251-8967-dea7-e063-6394a90a08b7
spl set id: 19a7b2fc-239c-b53c-e063-6394a90a0906

Reported adverse events (FAERS/openFDA)#

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