FDA.reportPublic FDA data

Antiseptic Hand Gel

Manufacturer
H and P Industries, Inc. dba Triad Group
Effective date
2009-11-23
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 22:22:53

Label at a glance#

ProductAntiseptic Hand Gel
Active ingredientalcohol
Label structure8 sections

Indications and uses

For handwashing when water is not available to decrease bacteria on the skin after changing diapers after assisting ill persons before contact with a person under medical care or treatment recommended for repeated use

Dosage and administration

Place a palmful of product in one hand Spread on both hands and rub into skin until dry (approx. 1-2 min.) Place a smaller amount into one hand Spread over hands to wrist and rub into skin until dry (approx. 30 sec.)

Storage and handling

Store at room temperature: 15°- 30° C (59° - 86° F)

Label contents#

Full prescribing information#

ACTIVE INGREDIENT

OTC - ACTIVE INGREDIENT SECTION

Ethyl Alcohol, 70% v/v

PURPOSE

OTC - PURPOSE SECTION

Antiseptic

USES

INDICATIONS & USAGE SECTION

For handwashing when water is not available to decrease bacteria on the skin

  • after changing diapers
  • after assisting ill persons
  • before contact with a person under medical care or treatment
  • recommended for repeated use

WARNINGS

WARNINGS SECTION

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

Do not use

OTC - DO NOT USE SECTION

in the eyes.

OTC - ASK DOCTOR SECTION


OTC - ASK DOCTOR/PHARMACIST SECTION

OTC - WHEN USING SECTION

Stop use and ask a doctor

OTC - STOP USE SECTION

  • if irritation and redness develop.
  • if condition persists for more than 72 hours

WARNINGS SECTION

OTC - PREGNANCY OR BREAST FEEDING SECTION

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

  • Place a palmful of product in one hand
  • Spread on both hands and rub into skin until dry (approx. 1-2 min.)
  • Place a smaller amount into one hand
  • Spread over hands to wrist and rub into skin until dry (approx. 30 sec.)

OTHER INFORMATION

STORAGE AND HANDLING SECTION

Store at room temperature: 15°- 30° C (59° - 86° F)

INACTIVE INGREDIENTS

INACTIVE INGREDIENT SECTION

aloe vera gel, carbomer 940, denatonium benzoate, fragrance, PEG-1450, tert-butyl alcohol, triethanolamine, water

LABEL INFORMATION

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Triad®

Cat. No. 10-8616
NDC 50730-8616-5


Antiseptic
Hand Gel
Reduces the risk of bacterial contamination and infection
Helps meet CDC, OSHA and APIC Guidelines for Hand Hygiene
Contains Aloe Vera Gel

Triad Group, Inc.
700 West North Shore Drive
Hartland, WI 53029
MADE IN USA
www.triad-group.net

16 fl. oz. (472 ml)

label
label

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
581662ethanol 70 % Topical GelPSN1
581662ethanol 0.7 ML/ML Topical GelSCD1
581662ethanol 70 % Topical GelSY1
581662ethyl alcohol 70 % Topical GelSY1

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
50730-8616-52019-10-21C16284748780-1956f9ecf-d950-621f-e053-dbdaa90a74adDRUG FACTS

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50730-8616-5Antiseptic Hand Gel472 mL in 1 BOTTLE, PLASTICGEL4721

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50730-8616ANTISEPTIC HAND GEL (ETHYL ALCOHOL) GEL [H AND P INDUSTRIES, INC. DBA TRIAD GROUP]1Legacy NDC, 1 package rows20091205_5e0fc163-52d5-424e-8778-af11695dd7b5.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
alcoholACTIVE INGREDIENT3K9958V90M1
alcoholACTIVE MOIETY3K9958V90M1
aloe vera leafINACTIVE INGREDIENTZY81Z83H0X1
carbomer homopolymer type cINACTIVE INGREDIENT4Q93RCW27E1
denatonium benzoateINACTIVE INGREDIENT4YK5Z54AT21
polyethylene glycol 1450INACTIVE INGREDIENTOJ4Z5Z32L41
tert-butyl alcoholINACTIVE INGREDIENTMD83SFE9591
trolamineINACTIVE INGREDIENT9O3K93S3TK1
waterINACTIVE INGREDIENT059QF0KO0R1

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
50730-861650730-8616-5

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 8 matching rows.

Name, UNII, Kind table
NameUNIIKind
alcohol3K9958V90MACTIB
aloe vera leafZY81Z83H0XIACT
carbomer homopolymer type c4Q93RCW27EIACT
denatonium benzoate4YK5Z54AT2IACT
polyethylene glycol 1450OJ4Z5Z32L4IACT
tert-butyl alcoholMD83SFE959IACT
trolamine9O3K93S3TKIACT
water059QF0KO0RIACT

Source Document#

Source XML

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 1 · 43 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
trolamineTROLAMINE9O3K93S3TKLIQUID / TOPICALNAExact identifier — unii candidate
22 equally ranked IID candidates
denatonium benzoateDENATONIUM BENZOATE4YK5Z54AT2GEL / TOPICALNAExact identifier — unii candidate
3 equally ranked IID candidates
trolamineTROLAMINE9O3K93S3TKSHAMPOO / TOPICAL3.7 %w/wExact identifier — unii candidate
22 equally ranked IID candidates
trolamineTROLAMINE9O3K93S3TKGEL / TOPICAL6 mgExact identifier — unii candidate
22 equally ranked IID candidates
trolamineTROLAMINE9O3K93S3TKDROPS / NASALNAExact identifier — unii candidate
22 equally ranked IID candidates
trolamineTROLAMINE9O3K93S3TKSPONGE / TOPICAL11 %w/wExact identifier — unii candidate
22 equally ranked IID candidates
polyethylene glycol 1450POLYETHYLENE GLYCOL 1450OJ4Z5Z32L4TABLET, EXTENDED RELEASE / ORAL9 mgExact identifier — unii candidate
8 equally ranked IID candidates
carbomer homopolymer type cCARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED)4Q93RCW27EGEL / TRANSDERMAL150 mgExact identifier — unii candidate
9 equally ranked IID candidates
trolamineTROLAMINE9O3K93S3TKCREAM, AUGMENTED / TOPICAL20 mgExact identifier — unii candidate
22 equally ranked IID candidates
trolamineTROLAMINE9O3K93S3TKAEROSOL, FOAM / TOPICAL2.6 %w/wExact identifier — unii candidate
22 equally ranked IID candidates
polyethylene glycol 1450POLYETHYLENE GLYCOL 1450OJ4Z5Z32L4SOLUTION / ORAL6108 mgExact identifier — unii candidate
8 equally ranked IID candidates
polyethylene glycol 1450POLYETHYLENE GLYCOL 1450OJ4Z5Z32L4TABLET / ORAL0.6 mgExact identifier — unii candidate
8 equally ranked IID candidates
trolamineTROLAMINE9O3K93S3TKGEL / TRANSDERMAL6 mgExact identifier — unii candidate
22 equally ranked IID candidates
trolamineTROLAMINE9O3K93S3TKCREAM / TOPICAL1 %w/wExact identifier — unii candidate
22 equally ranked IID candidates
trolamineTROLAMINE9O3K93S3TKAEROSOL, FOAM / VAGINAL2 %w/wExact identifier — unii candidate
22 equally ranked IID candidates
carbomer homopolymer type cCARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED)4Q93RCW27ECREAM / TOPICAL103 mgExact identifier — unii candidate
9 equally ranked IID candidates
denatonium benzoateDENATONIUM BENZOATE4YK5Z54AT2SWAB / TOPICALNAExact identifier — unii candidate
3 equally ranked IID candidates
trolamineTROLAMINE9O3K93S3TKLOTION / TOPICAL360 mgExact identifier — unii candidate
22 equally ranked IID candidates
carbomer homopolymer type cCARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED)4Q93RCW27EOINTMENT, AUGMENTED / TOPICAL23 mgExact identifier — unii candidate
9 equally ranked IID candidates
denatonium benzoateDENATONIUM BENZOATE4YK5Z54AT2SOLUTION / TOPICALNAExact identifier — unii candidate
3 equally ranked IID candidates
carbomer homopolymer type cCARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED)4Q93RCW27ECREAM, AUGMENTED / TOPICAL20 mgExact identifier — unii candidate
9 equally ranked IID candidates
trolamineTROLAMINE9O3K93S3TKGEL, METERED / TRANSDERMAL14 mgExact identifier — unii candidate
22 equally ranked IID candidates
trolamineTROLAMINE9O3K93S3TKCREAM / VAGINAL56 mgExact identifier — unii candidate
22 equally ranked IID candidates
carbomer homopolymer type cCARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED)4Q93RCW27ELOTION / TOPICAL300 mgExact identifier — unii candidate
9 equally ranked IID candidates
trolamineTROLAMINE9O3K93S3TKPOWDER / TOPICAL0.02 mg/mgExact identifier — unii candidate
22 equally ranked IID candidates
trolamineTROLAMINE9O3K93S3TKGEL, METERED / TOPICAL20 mgExact identifier — unii candidate
22 equally ranked IID candidates
polyethylene glycol 1450POLYETHYLENE GLYCOL 1450OJ4Z5Z32L4OINTMENT / TOPICAL921 mgExact identifier — unii candidate
8 equally ranked IID candidates
trolamineTROLAMINE9O3K93S3TKINJECTION, POWDER, FOR SUSPENSION / INTRAVENOUS0.02 %w/vExact identifier — unii candidate
22 equally ranked IID candidates
polyethylene glycol 1450POLYETHYLENE GLYCOL 1450OJ4Z5Z32L4TABLET, FILM COATED / ORAL0.13 mgExact identifier — unii candidate
8 equally ranked IID candidates
polyethylene glycol 1450POLYETHYLENE GLYCOL 1450OJ4Z5Z32L4SUPPOSITORY / URETHRAL9.75 mgExact identifier — unii candidate
8 equally ranked IID candidates
tert-butyl alcoholTERT-BUTYL ALCOHOLMD83SFE959GEL / TOPICAL0.12 %w/wExact identifier — unii candidate
trolamineTROLAMINE9O3K93S3TKSOAP / TOPICAL0.08 %w/wExact identifier — unii candidate
22 equally ranked IID candidates
polyethylene glycol 1450POLYETHYLENE GLYCOL 1450OJ4Z5Z32L4CAPSULE, EXTENDED RELEASE / ORAL91 mgExact identifier — unii candidate
8 equally ranked IID candidates
trolamineTROLAMINE9O3K93S3TKEMULSION / TOPICAL0.5 %w/wExact identifier — unii candidate
22 equally ranked IID candidates
trolamineTROLAMINE9O3K93S3TKSPRAY / NASALNAExact identifier — unii candidate
22 equally ranked IID candidates
carbomer homopolymer type cCARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED)4Q93RCW27EEMULSION / TOPICAL6 mgExact identifier — unii candidate
9 equally ranked IID candidates
carbomer homopolymer type cCARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED)4Q93RCW27EGEL / OPHTHALMIC4 %w/wExact identifier — unii candidate
9 equally ranked IID candidates
trolamineTROLAMINE9O3K93S3TKSOLUTION / NASALNAExact identifier — unii candidate
22 equally ranked IID candidates
trolamineTROLAMINE9O3K93S3TKSOLUTION / TOPICALNAExact identifier — unii candidate
22 equally ranked IID candidates
carbomer homopolymer type cCARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED)4Q93RCW27EGEL, METERED / TRANSDERMAL50 mgExact identifier — unii candidate
9 equally ranked IID candidates
trolamineTROLAMINE9O3K93S3TKAEROSOL, METERED / RECTALADJ PHExact identifier — unii candidate
22 equally ranked IID candidates
carbomer homopolymer type cCARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED)4Q93RCW27EGEL / TOPICAL85 mgExact identifier — unii candidate
9 equally ranked IID candidates
polyethylene glycol 1450POLYETHYLENE GLYCOL 1450OJ4Z5Z32L4SUSPENSION / ORAL4000 mgExact identifier — unii candidate
8 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
9d0fc5ee-99be-4b72-930f-ec3a7245f5925e0fc163-52d5-424e-8778-af11695dd7b52009-11-23WarningsExact identifier
spl id: 9d0fc5ee-99be-4b72-930f-ec3a7245f592
spl set id: 5e0fc163-52d5-424e-8778-af11695dd7b5

Reported adverse events (FAERS/openFDA)#

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