FDA.reportPublic FDA data

GFS BIOPROTECT HAND SANITIZER ALOE VERA

Manufacturer
GFS US LLC
Effective date
2013-04-03
Label type
HUMAN OTC DRUG LABEL
Version
7
Source
full-release
Hydrated at
2026-05-31 22:35:07

Label at a glance#

ProductGFS BIOPROTECT HAND SANITIZER ALOE VERA -
Active ingredientBenzalkonium Chloride
Label structure12 sections

Label contents#

Full prescribing information#

DESCRIPTION SECTION

BioProtect Hand Sanitizer contains 0.13% antiseptic agent Benzalkonium Chloride formulated with  Water,1-Ocatadecanaminium, N-N-dimethyl-N-[3-(trimethoxysilyl)propyl]-,chloride, C12-C15 Pareth-3, Polyaminopropyl biguanide, Caprylyl glucoside, Citronellol, Sorbic Acid, Glycerin, Aloe Barbadensis (Aloe) Leaf Extract, and  D and C Green No.5. It is alcohol-free, non-toxic and kills 99.99% of germs.

OTC - ACTIVE INGREDIENT SECTION

Benzalkonium Chloride 0.13%.............................................Antiseptic

OTC - PURPOSE SECTION

  • Antispetic

INDICATIONS & USAGE SECTION

  • Hand sanitizer to help decrease bacteria on skin
  • Recommended for repeated use

WARNINGS SECTION

  • For external use only
  • Do not use in ears or mouth

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

  • Keep out of reach on children
  • Children must be supervised in use of this product

DOSAGE & ADMINISTRATION SECTION

  • Apply a small amount into your palm and thoroughly spread on both hands
  • Rub into skin until dry

GENERAL PRECAUTIONS SECTION

  • Review MSDS before handling the product

OTC - WHEN USING SECTION

  • When using this product do not use in ears or mouth
  • Avoid contact with eyes
  • In case of eye contact, rinse eyes thoroughly with water

OTC - STOP USE SECTION

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

INACTIVE INGREDIENT SECTION

  • Water,1-Ocatadecanaminium, N-N-dimethyl-N-[3-(trimethoxysilyl)propyl]-,chloride, C12-C15 Pareth-3, Polyaminopropyl biguanide, Caprylyl glucoside, Citronellol, Sorbic Acid, Glycerin, Aloe Barbadensis (Aloe) Leaf Extract, and  D and C Green No.5

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

GFS_SPRAY
GFS_SPRAY

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1039012benzalkonium chloride 0.13 % Topical SprayPSN7
1039012benzalkonium chloride 1.3 MG/ML Topical SpraySCD7
1039012benzalkonium chloride 0.13 % Topical SpraySY7

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
76426-011-012019-11-27C16284748780-19855d018-d8da-cd31-e053-dbdaa90ab51aDRUG FACTS
76426-011-022019-11-27C16284748780-19855d018-d8da-cd31-e053-dbdaa90ab51aDRUG FACTS
76426-011-032019-11-27C16284748780-19855d018-d8da-cd31-e053-dbdaa90ab51aDRUG FACTS
76426-011-042019-11-27C16284748780-19855d018-d8da-cd31-e053-dbdaa90ab51aDRUG FACTS
76426-011-052019-11-27C16284748780-19855d018-d8da-cd31-e053-dbdaa90ab51aDRUG FACTS
76426-011-062019-11-27C16284748780-19855d018-d8da-cd31-e053-dbdaa90ab51aDRUG FACTS
76426-011-072019-11-27C16284748780-19855d018-d8da-cd31-e053-dbdaa90ab51aDRUG FACTS
76426-011-082019-11-27C16284748780-19855d018-d8da-cd31-e053-dbdaa90ab51aDRUG FACTS
76426-011-092019-11-27C16284748780-19855d018-d8da-cd31-e053-dbdaa90ab51aDRUG FACTS
76426-011-102019-11-27C16284748780-19855d018-d8da-cd31-e053-dbdaa90ab51aDRUG FACTS
76426-011-112019-11-27C16284748780-19855d018-d8da-cd31-e053-dbdaa90ab51aDRUG FACTS
76426-011-122019-11-27C16284748780-19855d018-d8da-cd31-e053-dbdaa90ab51aDRUG FACTS

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
76426-011-01GFS BIOPROTECT HAND SANITIZER ALOE VERA-11 g in 1 BOTTLE, SPRAYSPRAY117
76426-011-02GFS BIOPROTECT HAND SANITIZER ALOE VERA-28 g in 1 BOTTLE, SPRAYSPRAY287
76426-011-03GFS BIOPROTECT HAND SANITIZER ALOE VERA-55 g in 1 BOTTLE, SPRAYSPRAY557
76426-011-04GFS BIOPROTECT HAND SANITIZER ALOE VERA-110 g in 1 BOTTLE, SPRAYSPRAY1107
76426-011-05GFS BIOPROTECT HAND SANITIZER ALOE VERA-225 g in 1 BOTTLE, SPRAYSPRAY2257
76426-011-06GFS BIOPROTECT HAND SANITIZER ALOE VERA-1000 g in 1 BOTTLESPRAY10007
76426-011-07GFS BIOPROTECT HAND SANITIZER ALOE VERA-3790 g in 1 BOTTLESPRAY37907
76426-011-08GFS BIOPROTECT HAND SANITIZER ALOE VERA-204300 g in 1 DRUMSPRAY2043007
76426-011-09GFS BIOPROTECT HAND SANITIZER ALOE VERA-2204600 g in 1 CONTAINER, FLEXIBLE INTERMEDIATE BULKSPRAY22046007
76426-011-10GFS BIOPROTECT HAND SANITIZER ALOE VERA-800 g in 1 BAGSPRAY8007
76426-011-11GFS BIOPROTECT HAND SANITIZER ALOE VERA-1200 g in 1 BAGSPRAY12007
76426-011-12GFS BIOPROTECT HAND SANITIZER ALOE VERA-1800 g in 1 BAGSPRAY18007

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
76426-011GFS BIOPROTECT HAND SANITIZER ALOE VERA - (BENZALKONIUM CHLORIDE ) SPRAY [GFS US LLC]7Legacy NDC, 12 package rows20130404_796876f1-2f13-46a2-a410-37438a4de02d.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
Benzalkonium ChlorideACTIVE INGREDIENTF5UM2KM3W77
BenzalkoniumACTIVE MOIETY7N6JUD5X6Y7
.BETA.-CITRONELLOL, (+/-)-INACTIVE INGREDIENT565OK72VNF7
ALOE VERA LEAFINACTIVE INGREDIENTZY81Z83H0X7
C12-15 PARETH-12INACTIVE INGREDIENT131316X18L7
CAPRYLYL GLUCOSIDEINACTIVE INGREDIENTV109WUT6RL7
D&C Green No. 5INACTIVE INGREDIENT8J6RDU8L9X7
DIMETHYLOCTADECYL(3-(TRIMETHOXYSILYL)PROPYL)AMMONIUM CHLORIDEINACTIVE INGREDIENTIQ36O85WQ47
GLYCERININACTIVE INGREDIENTPDC6A3C0OX7
POLYAMINOPROPYL BIGUANIDEINACTIVE INGREDIENT322U039GMF7
SORBIC ACIDINACTIVE INGREDIENTX045WJ989B7
WaterINACTIVE INGREDIENT059QF0KO0R7

Products#

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

DailyMed product names page 1 of 1 · 13 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
76426-01176426-011-01, 76426-011-02, 76426-011-03, 76426-011-04, 76426-011-05, 76426-011-06, 76426-011-07, 76426-011-08, 76426-011-09, 76426-011-10, 76426-011-11, 76426-011-12

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 11 matching rows.

Name, UNII, Kind table
NameUNIIKind
Benzalkonium ChlorideF5UM2KM3W7ACTIB
Water059QF0KO0RIACT
DIMETHYLOCTADECYL(3-(TRIMETHOXYSILYL)PROPYL)AMMONIUM CHLORIDEIQ36O85WQ4IACT
C12-15 PARETH-12131316X18LIACT
POLYAMINOPROPYL BIGUANIDE322U039GMFIACT
CAPRYLYL GLUCOSIDEV109WUT6RLIACT
.BETA.-CITRONELLOL, (+/-)-565OK72VNFIACT
SORBIC ACIDX045WJ989BIACT
GLYCERINPDC6A3C0OXIACT
ALOE VERA LEAFZY81Z83H0XIACT
D&C Green No. 58J6RDU8L9XIACT

Source Document#

Source XML · Source PDF

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 2 · 100 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
SORBIC ACIDSORBIC ACIDX045WJ989BTABLET, COATED / ORAL1 mgExact identifier — unii candidate
19 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSOLUTION, CONCENTRATE / ORAL200 mg/1mlExact identifier — unii candidate
75 equally ranked IID candidates
SORBIC ACIDSORBIC ACIDX045WJ989BLOTION / TOPICAL4 mgExact identifier — unii candidate
19 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSOLUTION / ORAL32400 mgExact identifier — unii candidate
75 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXJELLY / VAGINALNAExact identifier — unii candidate
75 equally ranked IID candidates
SORBIC ACIDSORBIC ACIDX045WJ989BSOLUTION/ DROPS / OPHTHALMIC0.2 %w/vExact identifier — unii candidate
19 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXTABLET / ORAL42 mgExact identifier — unii candidate
75 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXINJECTION, SOLUTION / INTRAMUSCULAR15 %w/vExact identifier — unii candidate
75 equally ranked IID candidates
SORBIC ACIDSORBIC ACIDX045WJ989BTABLET / ORAL10 mgExact identifier — unii candidate
19 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXCAPSULE, LIQUID FILLED / ORAL185 mgExact identifier — unii candidate
75 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXINJECTION, SUSPENSION / SUBCUTANEOUS1.6 %w/vExact identifier — unii candidate
75 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXCLOTH / TOPICAL0.05 mg/mgExact identifier — unii candidate
75 equally ranked IID candidates
SORBIC ACIDSORBIC ACIDX045WJ989BTABLET, FILM COATED, EXTENDED RELEASE / ORAL1 mgExact identifier — unii candidate
19 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXDOUCHE / VAGINAL1 %w/wExact identifier — unii candidate
75 equally ranked IID candidates
SORBIC ACIDSORBIC ACIDX045WJ989BGEL / TOPICAL2 mgExact identifier — unii candidate
19 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSOLUTION / DENTAL15 %w/vExact identifier — unii candidate
75 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXJELLY / TOPICALNAExact identifier — unii candidate
75 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSOLUTION/ DROPS / OPHTHALMIC12 mgExact identifier — unii candidate
75 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSUSPENSION/ DROPS / ORAL750 mgExact identifier — unii candidate
75 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXCAPSULE / ORAL3487 mgExact identifier — unii candidate
75 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSOLUTION/ DROPS / AURICULAR (OTIC)25 mgExact identifier — unii candidate
75 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSPRAY, METERED / NASAL13 mgExact identifier — unii candidate
75 equally ranked IID candidates
SORBIC ACIDSORBIC ACIDX045WJ989BOINTMENT / TOPICAL0.1 %w/wExact identifier — unii candidate
19 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXMOUTHWASH / BUCCAL100 mg/1mlExact identifier — unii candidate
75 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSOLUTION / NASAL25 mg/1mlExact identifier — unii candidate
75 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXCREAM / TOPICAL1720 mgExact identifier — unii candidate
75 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXINJECTION, SOLUTION / SUBCUTANEOUS15 %w/vExact identifier — unii candidate
75 equally ranked IID candidates
D&C Green No. 5D&C GREEN NO. 58J6RDU8L9XSOLUTION / ORALNAExact identifier — unii candidate
6 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXINJECTION / INTRAVENOUS33750 mgExact identifier — unii candidate
75 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXGEL / TOPICAL500 mgExact identifier — unii candidate
75 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXGUM, CHEWING / BUCCAL230 mgExact identifier — unii candidate
75 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSYRUP / ORAL16734 mgExact identifier — unii candidate
75 equally ranked IID candidates
SORBIC ACIDSORBIC ACIDX045WJ989BEMULSION / OPHTHALMIC1 mgExact identifier — unii candidate
19 equally ranked IID candidates
D&C Green No. 5D&C GREEN NO. 58J6RDU8L9XSHAMPOO / TOPICAL0.09 %w/wExact identifier — unii candidate
6 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXINJECTION, SOLUTION / INTRAVENOUS15 %w/vExact identifier — unii candidate
75 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSUPPOSITORY / RECTAL440 mgExact identifier — unii candidate
75 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSOAP / TOPICAL0.76 %w/wExact identifier — unii candidate
75 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXFILM, EXTENDED RELEASE / BUCCAL34 mgExact identifier — unii candidate
75 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXELIXIR / ORAL5621 mgExact identifier — unii candidate
75 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXPASTE / ORAL3822 mgExact identifier — unii candidate
75 equally ranked IID candidates
SORBIC ACIDSORBIC ACIDX045WJ989BTABLET / SUBLINGUAL0.16 mgExact identifier — unii candidate
19 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSOLUTION / TOPICAL1971 mgExact identifier — unii candidate
75 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXINJECTION / SUBCUTANEOUS450 mgExact identifier — unii candidate
75 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSUSPENSION/ DROPS / OPHTHALMIC2.5 %w/vExact identifier — unii candidate
75 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXPASTE / DENTAL20 %w/wExact identifier — unii candidate
75 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXLOTION / TOPICAL3990 mgExact identifier — unii candidate
75 equally ranked IID candidates
SORBIC ACIDSORBIC ACIDX045WJ989BSYRUP / ORAL80 mgExact identifier — unii candidate
19 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSOLUTION / RESPIRATORY (INHALATION)5 %w/wExact identifier — unii candidate
75 equally ranked IID candidates
SORBIC ACIDSORBIC ACIDX045WJ989BTABLET, DELAYED RELEASE / ORAL0.03 mgExact identifier — unii candidate
19 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXINJECTION / INTRAMUSCULAR450 mgExact identifier — unii candidate
75 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSUSPENSION / OPHTHALMIC58 mgExact identifier — unii candidate
75 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXTABLET, EXTENDED RELEASE / ORAL7 mgExact identifier — unii candidate
75 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXTABLET, COATED / ORAL1 mgExact identifier — unii candidate
75 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXDROPS / NASAL10 mg/1mlExact identifier — unii candidate
75 equally ranked IID candidates
D&C Green No. 5D&C GREEN NO. 58J6RDU8L9XTABLET / ORAL0.03 mgExact identifier — unii candidate
6 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSYSTEM / TOPICAL18144 mgExact identifier — unii candidate
75 equally ranked IID candidates
SORBIC ACIDSORBIC ACIDX045WJ989BCREAM / TOPICAL14 mgExact identifier — unii candidate
19 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXINJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / INTRAVENOUS225 mgExact identifier — unii candidate
75 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSUSPENSION / ORAL26208 mgExact identifier — unii candidate
75 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSUSPENSION, EXTENDED RELEASE / ORAL2000 mgExact identifier — unii candidate
75 equally ranked IID candidates

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
2c12dd4f-dbdc-49ee-bac6-5ddd0fff5d70796876f1-2f13-46a2-a410-37438a4de02d2013-04-03WarningsExact identifier
spl id: 2c12dd4f-dbdc-49ee-bac6-5ddd0fff5d70
spl set id: 796876f1-2f13-46a2-a410-37438a4de02d

Reported adverse events (FAERS/openFDA)#

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