FDA.reportPublic FDA data

Instant Hand Sanitizer

Manufacturer
Air Techniques | Safetec of America, Inc.
Effective date
2015-07-10
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 23:02:41

Label at a glance#

ProductInstant Hand Sanitizer
Active ingredientalcohol
Label structure10 sections

Indications and uses

Cleansing gel for hands that need frequent care. Decrease bacteria on skin. Recommended for repeated use.

Dosage and administration

place a small amount into one hand spread over both hands and wrist rub into the skin until dry do not wipe off; no rinsing required

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Ethyl alcohol 66.5%

Purpose

OTC - PURPOSE SECTION

Antiseptic

Uses:

INDICATIONS & USAGE SECTION

  • Cleansing gel for hands that need frequent care.
  • Decrease bacteria on skin.
  • Recommended for repeated use.

Warnings:

WARNINGS SECTION

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

When using this product

OTC - WHEN USING SECTION

  • do not get into eyes. If contact occurs, rinse eyes thoroughly with water

Stop use and ask doctor if

OTC - STOP USE SECTION

  • irritation and redness develop and 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

  • place a small amount into one hand
  • spread over both hands and wrist
  • rub into the skin until dry
  • do not wipe off; no rinsing required

Other Information

SPL UNCLASSIFIED SECTION

  • store at 55° to 82°F

Inactive Ingredients

INACTIVE INGREDIENT SECTION

aloe vera, carbomer, fragrance, purified water, triethanolamine

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Principal Display Panel - 2 fl. oz. Label

Apple Scent

NEW CLEAR FORMULA

Monarch®

Hydrating Instant Hand Sanitizer

Cleansing gel for
hands that need frequent care.
Decreases bacteria on skin.

Enriched with Aloe Vera.
Leaves hands feeling
smooth and silky.

Order No. H6500-N (16 oz. Bottle)

Distributed By

AIR TECHNIQUES

equipped for life®

www.airtechniques.com

1295 Welt Whitman Road

Melville, NY 11747-3062

Net Contents:

2 fl. oz. / 60mL

Rev. A

Principal Display Panel - 2 fl. oz. Label
Principal Display Panel - 2 fl. oz. Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Principal Display Panel - 16 fl. oz. Label

Apple Scent

NEW CLEAR FORMULA

Monarch®

Hydrating Instant Hand Sanitizer

Cleansing gel for
hands that need frequent care.
Decreases bacteria on skin.

Enriched with Aloe Vera.
Leaves hands feeling
smooth and silky.

Order No. H6500-N

Net Contents: 16 fl. oz. / 473 mL

Distributed By

AIR TECHNIQUES

equipped for life®

Rev. A

Principal Display Panel - 16 fl. oz. Label
Principal Display Panel - 16 fl. oz. Label

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
69965-8111-12021-01-29C16284748780-1ba0f9c33-21b3-a910-e053-dadaa90a0b85d948e4a8-41f0-4a65-b7d6-3f8932c83f38
69965-8111-22021-01-29C16284748780-1ba0f9c33-21b3-a910-e053-dadaa90a0b85d948e4a8-41f0-4a65-b7d6-3f8932c83f38

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69965-8111-1Instant Hand Sanitizer473 mL in 1 BOTTLEGEL4732
69965-8111-2Instant Hand Sanitizer60 mL in 1 BOTTLEGEL602

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69965-8111INSTANT HAND SANITIZER (ALCOHOL) GEL [AIR TECHNIQUES]2Legacy NDC, 2 package rows20200101_d948e4a8-41f0-4a65-b7d6-3f8932c83f38.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
alcoholACTIVE INGREDIENT3K9958V90M1
alcoholACTIVE MOIETY3K9958V90M1
aloeINACTIVE INGREDIENTV5VD430YW91
trolamineINACTIVE INGREDIENT9O3K93S3TK1
waterINACTIVE INGREDIENT059QF0KO0R1

Products#

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

DailyMed product names page 1 of 1 · 5 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
69965-811169965-8111-1, 69965-8111-2

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 4 matching rows.

Name, UNII, Kind table
NameUNIIKind
alcohol3K9958V90MACTIB
aloeV5VD430YW9IACT
water059QF0KO0RIACT
trolamine9O3K93S3TKIACT

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 · 22 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
trolamineTROLAMINE9O3K93S3TKINJECTION, POWDER, FOR SUSPENSION / INTRAVENOUS0.02 %w/vExact identifier — unii candidate
22 equally ranked IID candidates
trolamineTROLAMINE9O3K93S3TKCREAM, AUGMENTED / TOPICAL20 mgExact identifier — unii candidate
22 equally ranked IID candidates
trolamineTROLAMINE9O3K93S3TKLIQUID / TOPICALNAExact identifier — unii candidate
22 equally ranked IID candidates
trolamineTROLAMINE9O3K93S3TKAEROSOL, FOAM / VAGINAL2 %w/wExact identifier — unii candidate
22 equally ranked IID candidates
trolamineTROLAMINE9O3K93S3TKEMULSION / TOPICAL0.5 %w/wExact identifier — unii candidate
22 equally ranked IID candidates
trolamineTROLAMINE9O3K93S3TKSOLUTION / NASALNAExact identifier — unii candidate
22 equally ranked IID candidates
trolamineTROLAMINE9O3K93S3TKSHAMPOO / TOPICAL3.7 %w/wExact identifier — unii candidate
22 equally ranked IID candidates
trolamineTROLAMINE9O3K93S3TKGEL, METERED / TRANSDERMAL14 mgExact identifier — unii candidate
22 equally ranked IID candidates
trolamineTROLAMINE9O3K93S3TKSPONGE / TOPICAL11 %w/wExact identifier — unii candidate
22 equally ranked IID candidates
trolamineTROLAMINE9O3K93S3TKGEL / TOPICAL6 mgExact identifier — unii candidate
22 equally ranked IID candidates
trolamineTROLAMINE9O3K93S3TKLOTION / TOPICAL360 mgExact identifier — unii candidate
22 equally ranked IID candidates
trolamineTROLAMINE9O3K93S3TKAEROSOL, FOAM / TOPICAL2.6 %w/wExact identifier — unii candidate
22 equally ranked IID candidates
trolamineTROLAMINE9O3K93S3TKDROPS / NASALNAExact identifier — unii candidate
22 equally ranked IID candidates
trolamineTROLAMINE9O3K93S3TKGEL / TRANSDERMAL6 mgExact identifier — unii candidate
22 equally ranked IID candidates
trolamineTROLAMINE9O3K93S3TKPOWDER / TOPICAL0.02 mg/mgExact identifier — unii candidate
22 equally ranked IID candidates
trolamineTROLAMINE9O3K93S3TKCREAM / VAGINAL56 mgExact identifier — unii candidate
22 equally ranked IID candidates
trolamineTROLAMINE9O3K93S3TKSPRAY / NASALNAExact identifier — unii candidate
22 equally ranked IID candidates
trolamineTROLAMINE9O3K93S3TKAEROSOL, METERED / RECTALADJ PHExact identifier — unii candidate
22 equally ranked IID candidates
trolamineTROLAMINE9O3K93S3TKSOAP / TOPICAL0.08 %w/wExact identifier — unii candidate
22 equally ranked IID candidates
trolamineTROLAMINE9O3K93S3TKGEL, METERED / TOPICAL20 mgExact identifier — unii candidate
22 equally ranked IID candidates
trolamineTROLAMINE9O3K93S3TKSOLUTION / TOPICALNAExact identifier — unii candidate
22 equally ranked IID candidates
trolamineTROLAMINE9O3K93S3TKCREAM / TOPICAL1 %w/wExact identifier — unii candidate
22 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
e7feea3b-6ea9-448a-b2b6-9f3e0711bf8ad948e4a8-41f0-4a65-b7d6-3f8932c83f382015-07-10WarningsExact identifier
spl id: e7feea3b-6ea9-448a-b2b6-9f3e0711bf8a
spl set id: d948e4a8-41f0-4a65-b7d6-3f8932c83f38

Reported adverse events (FAERS/openFDA)#

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