FDA.reportPublic FDA data

DrPuRx HAND SANITIZER

Manufacturer
Loom USA | LoomUSA LLC
Effective date
2022-08-02
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-05-31 23:50:20

Label at a glance#

ProductDrPuRx HAND SANITIZER
Active ingredientALCOHOL
Label structure10 sections

Indications and uses

to decrease bacteria on the skin that could cause disease recommended for repeated use

Dosage and administration

wet hands thoroughly with product and allow to dry without wiping for children under 6, use only under adult supervision not recommended for infants

Storage and handling

do not store above 85° may discolor some fabrics harmful to wood finished and plastics

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Ethyl Alcohol 70%

Purpose

OTC - PURPOSE SECTION

Antimicrobial

Uses

INDICATIONS & USAGE SECTION

  • to decrease bacteria on the skin that could cause disease
  • recommended for repeated use

Warnings

WARNINGS SECTION

For external use only: hands

Flammable, keep away from fire or flame

When using this product

OTC - WHEN USING SECTION

  • keep out of eyes. In case of contact with eyes, flush thoroughly with water.
  • avoid contact with broken skin
  • do not inhale or ingest.

Stop use and ask a doctor if

OTC - STOP USE SECTION

  • irritation and redness develop
  • condition 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

  • wet hands thoroughly with product and allow to dry without wiping
  • for children under 6, use only under adult supervision
  • not recommended for infants

Other information

STORAGE AND HANDLING SECTION

  • do not store above 85°
  • may discolor some fabrics
  • harmful to wood finished and plastics

Inactive ingredients

INACTIVE INGREDIENT SECTION

water, acrylates/C10-30 alkyl acrylate crosspolymer, sodium PCA, hyaluronic acid

SPL UNCLASSIFIED SECTION

Distributed by:
LoomUSA LLC
3 Graphics Dr
Ewing, NJ 08628

Manufactured by:
LoomUSA LLC
FDA Registered Facility

PRINCIPAL DISPLAY PANEL - 499.79 mL Bottle Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Made in
the USA

DrPuRX

HAND SANITIZER

Kills more than 99% of infectious agents*

Moisturizers leavehands smooth

16.9 FL OZ (499.79mL)

Principal Display Panel - 499.79 mL Bottle Label
Principal Display Panel - 499.79 mL Bottle Label

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
581662ethanol 70 % Topical GelPSN3
581662ethanol 0.7 ML/ML Topical GelSCD3
581662ethanol 70 % Topical GelSY3
581662ethyl alcohol 70 % Topical GelSY3

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
80607-921-012023-07-28C16284748780-1e4f33bdf-a42e-d8a0-e053-dadaa90a6e4eDrPuRx HAND SANITIZER
80607-921-022023-07-28C16284748780-1e4f33bdf-a42e-d8a0-e053-dadaa90a6e4eDrPuRx HAND SANITIZER
80607-921-032023-07-28C16284748780-1e4f33bdf-a42e-d8a0-e053-dadaa90a6e4eDrPuRx HAND SANITIZER
80607-921-042023-07-28C16284748780-1e4f33bdf-a42e-d8a0-e053-dadaa90a6e4eDrPuRx HAND SANITIZER
80607-921-052023-07-28C16284748780-1e4f33bdf-a42e-d8a0-e053-dadaa90a6e4eDrPuRx HAND SANITIZER
80607-921-062023-07-28C16284748780-1e4f33bdf-a42e-d8a0-e053-dadaa90a6e4eDrPuRx HAND SANITIZER
80607-921-012022-08-03C16284748780-1e4f33bdf-a42e-d8a0-e053-dadaa90a6e4eDrPuRx HAND SANITIZER
80607-921-022022-08-03C16284748780-1e4f33bdf-a42e-d8a0-e053-dadaa90a6e4eDrPuRx HAND SANITIZER
80607-921-032022-08-03C16284748780-1e4f33bdf-a42e-d8a0-e053-dadaa90a6e4eDrPuRx HAND SANITIZER
80607-921-042022-08-03C16284748780-1e4f33bdf-a42e-d8a0-e053-dadaa90a6e4eDrPuRx HAND SANITIZER
80607-921-052022-08-03C16284748780-1e4f33bdf-a42e-d8a0-e053-dadaa90a6e4eDrPuRx HAND SANITIZER
80607-921-062022-08-03C16284748780-1e4f33bdf-a42e-d8a0-e053-dadaa90a6e4eDrPuRx HAND SANITIZER
80607-921-012022-07-29C16284748780-1e4f33bdf-a42e-d8a0-e053-dadaa90a6e4eDrPuRx HAND SANITIZER
80607-921-022022-07-29C16284748780-1e4f33bdf-a42e-d8a0-e053-dadaa90a6e4eDrPuRx HAND SANITIZER
80607-921-032022-07-29C16284748780-1e4f33bdf-a42e-d8a0-e053-dadaa90a6e4eDrPuRx HAND SANITIZER
80607-921-042022-07-29C16284748780-1e4f33bdf-a42e-d8a0-e053-dadaa90a6e4eDrPuRx HAND SANITIZER
80607-921-052022-07-29C16284748780-1e4f33bdf-a42e-d8a0-e053-dadaa90a6e4eDrPuRx HAND SANITIZER
80607-921-062022-07-29C16284748780-1e4f33bdf-a42e-d8a0-e053-dadaa90a6e4eDrPuRx HAND SANITIZER

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
80607-921-01DrPuRx HAND SANITIZER250 mL in 1 BOTTLEGEL2503
80607-921-02DrPuRx HAND SANITIZER500 mL in 1 BOTTLEGEL5003
80607-921-03DrPuRx HAND SANITIZER50 mL in 1 BOTTLEGEL503
80607-921-04DrPuRx HAND SANITIZER118.2 mL in 1 BOTTLEGEL118.23
80607-921-05DrPuRx HAND SANITIZER3785.4 mL in 1 BOTTLEGEL3785.43
80607-921-06DrPuRx HAND SANITIZER208197.65 mL in 1 DRUMGEL208197.653

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
80607-921DRPURX HAND SANITIZER (ALCOHOL) GEL [LOOM USA]3Legacy NDC, 6 package rows20220808_959e4f6e-9ef0-401f-b4b5-eefceb5010f0.zip

Products#

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

DailyMed product names page 1 of 1 · 6 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
80607-92180607-921-01, 80607-921-02, 80607-921-03, 80607-921-04, 80607-921-05, 80607-921-06

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 5 matching rows.

Name, UNII, Kind table
NameUNIIKind
ALCOHOL3K9958V90MACTIB
WATER059QF0KO0RIACT
CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED)59TL3WG5COIACT
SODIUM PYRROLIDONE CARBOXYLATE469OTG57A2IACT
HYALURONIC ACIDS270N0TRQYIACT

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
f1a708cc-db5e-4a28-8f70-3d1a97e5ee1a959e4f6e-9ef0-401f-b4b5-eefceb5010f02022-08-02WarningsExact identifier
spl id: f1a708cc-db5e-4a28-8f70-3d1a97e5ee1a
spl set id: 959e4f6e-9ef0-401f-b4b5-eefceb5010f0

Reported adverse events (FAERS/openFDA)#

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