FDA.reportPublic FDA data

Orbit Hand Sanitizer

Manufacturer
ORBIT CAPITAL LLC
Effective date
2020-08-27
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:28:37

Label at a glance#

ProductOrbit Hand Sanitizer
Active ingredientISOPROPYL ALCOHOL
Label structure10 sections

Indications and uses

▪ For hand-washing to decrease bacteria on the skin. ▪ Recommended for repeated use. ▪ Avoid contact with broken skin. ▪ Do not inhale or ingest.

Dosage and administration

Wet hands thoroughly with product and allow to dry without wiping. For children under 6 years, use only under adult supervision. Not a recommendation for infants

Storage and handling

Do not store above 105°F May discolor some fabrics Harmful to wood finishes and plastics

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Isopropyl Alcohol (IPA) 70%

Purpose

OTC - PURPOSE SECTION

Antiseptic

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Glycerine, DM Sterile water, Carbomer, Vitamin E, Aloe Extract, H2O2, Triethanolamine

Uses

INDICATIONS & USAGE SECTION

▪ For hand-washing to decrease bacteria on the skin.

▪ Recommended for repeated use.

▪ Avoid contact with broken skin.

▪ Do not inhale or ingest.

Other information

STORAGE AND HANDLING SECTION

Do not store above 105°F

May discolor some fabrics

Harmful to wood finishes and plastics

Questions?

OTC - QUESTIONS SECTION

+1(877)793-8998

Warnings

WARNINGS SECTION

FOR EXTERNAL USE ONLY - HANDS

Flammable. Keep away from heat and flame.

When using this product • Keep out of eyes. In case of contact with eyes, flush thoroughly with water.

Stop use and ask a doctor if skin irritates develops.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keeps 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, use only under adult supervision.

Not a recommendation for infants

SPL UNCLASSIFIED SECTION

Instant HAND SANITIZER with MOISTURIZERS & VITAMIN E

KILLS ILLNESS CAUSING GERMS UPTO 99.9%

Manufactured and Distributed

by: Orbit Capital, LLC

Stafford, Texas.

www.orbitcapitalllc.com

Made in USA

Packaging

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

PackagingPackaging

PackagingPackaging

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
581698isopropyl alcohol 70 % Topical GelPSN1
581698isopropyl alcohol 0.7 ML/ML Topical GelSCD1
581698isopropyl alcohol 70 % Topical GelSY1

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
6c13b22c-b3ba-4127-b768-0132dd5ab0d1Product name120230829
5eb9f24b-9328-475e-af0a-18021935eb6aProduct name120180220

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
78752-646-022023-01-30C16284748780-1f386c649-dacb-0266-e053-dadaa90a7c1aORBIT HAND SANITIZER
78752-646-042023-01-30C16284748780-1f386c649-dacb-0266-e053-dadaa90a7c1aORBIT HAND SANITIZER
78752-646-062023-01-30C16284748780-1f386c649-dacb-0266-e053-dadaa90a7c1aORBIT HAND SANITIZER
78752-646-082023-01-30C16284748780-1f386c649-dacb-0266-e053-dadaa90a7c1aORBIT HAND SANITIZER
78752-646-102023-01-30C16284748780-1f386c649-dacb-0266-e053-dadaa90a7c1aORBIT HAND SANITIZER
78752-646-122023-01-30C16284748780-1f386c649-dacb-0266-e053-dadaa90a7c1aORBIT HAND SANITIZER
78752-646-142023-01-30C16284748780-1f386c649-dacb-0266-e053-dadaa90a7c1aORBIT HAND SANITIZER
78752-646-162023-01-30C16284748780-1f386c649-dacb-0266-e053-dadaa90a7c1aORBIT HAND SANITIZER
78752-646-182023-01-30C16284748780-1f386c649-dacb-0266-e053-dadaa90a7c1aORBIT HAND SANITIZER
78752-646-222023-01-30C16284748780-1f386c649-dacb-0266-e053-dadaa90a7c1aORBIT HAND SANITIZER
78752-646-242023-01-30C16284748780-1f386c649-dacb-0266-e053-dadaa90a7c1aORBIT HAND SANITIZER
78752-646-262023-01-30C16284748780-1f386c649-dacb-0266-e053-dadaa90a7c1aORBIT HAND SANITIZER
78752-646-282023-01-30C16284748780-1f386c649-dacb-0266-e053-dadaa90a7c1aORBIT HAND SANITIZER
78752-646-302023-01-30C16284748780-1f386c649-dacb-0266-e053-dadaa90a7c1aORBIT HAND SANITIZER

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
78752-646-02Orbit Hand Sanitizer60 mL in 1 BOTTLEGEL601
78752-646-04Orbit Hand Sanitizer118 mL in 1 BOTTLEGEL1181
78752-646-06Orbit Hand Sanitizer180 mL in 1 BOTTLEGEL1801
78752-646-08Orbit Hand Sanitizer236 mL in 1 BOTTLEGEL2361
78752-646-10Orbit Hand Sanitizer3785 mL in 1 BOTTLEGEL37851
78752-646-12Orbit Hand Sanitizer24 in 1 BOXGEL241
78752-646-14Orbit Hand Sanitizer24 in 1 BOXGEL241
78752-646-16Orbit Hand Sanitizer24 in 1 BOXGEL241
78752-646-18Orbit Hand Sanitizer16 in 1 BOXGEL161
78752-646-22Orbit Hand Sanitizer6 in 1 CASEGEL61
78752-646-24Orbit Hand Sanitizer6 in 1 CASEGEL61
78752-646-26Orbit Hand Sanitizer6 in 1 CASEGEL61
78752-646-28Orbit Hand Sanitizer6 in 1 CASEGEL61
78752-646-30Orbit Hand Sanitizer4 in 1 CASEGEL41

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
78752-646ORBIT HAND SANITIZER (ISOPROPYL ALCOHOL) GEL [ORBIT CAPITAL LLC]1Legacy NDC, 14 package rows20200908_44d8bc50-3d8d-414e-883d-9f64606a7486.zip

Products#

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

DailyMed product names page 1 of 1 · 9 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
78752-64678752-646-02, 78752-646-12, 78752-646-22, 78752-646-04, 78752-646-14, 78752-646-24, 78752-646-06, 78752-646-16, 78752-646-26, 78752-646-08, 78752-646-18, 78752-646-28, 78752-646-10, 78752-646-30

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
ISOPROPYL ALCOHOLND2M416302ACTIB
GLYCERINPDC6A3C0OXIACT
WATER059QF0KO0RIACT
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE0A5MM307FCIACT
.ALPHA.-TOCOPHEROLH4N855PNZ1IACT
ALOEV5VD430YW9IACT
HYDROGEN PEROXIDEBBX060AN9VIACT
TROLAMINE9O3K93S3TKIACT

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
ac7a5151-9e09-4dd7-beb3-06423a708caa44d8bc50-3d8d-414e-883d-9f64606a74862020-08-27WarningsExact identifier
spl id: ac7a5151-9e09-4dd7-beb3-06423a708caa
spl set id: 44d8bc50-3d8d-414e-883d-9f64606a7486

Reported adverse events (FAERS/openFDA)#

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