FDA.reportPublic FDA data

PURELL Waterless Surgical Scrub

Manufacturer
GOJO Industries, Inc.
Effective date
2024-12-16
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-06-01 00:44:04

Label at a glance#

ProductPURELL Waterless Surgical Scrub
Active ingredientALCOHOL
Label structure7 sections

Indications and uses

Significantly reduces the number of micro-organisms on the hands and forearms prior to surgery or patient care

Dosage and administration

clean under the nails with a nail pick mails should be maintained with a 1 millimeter free edge place 2 mL of product into palm of one hand dip fingers of opposite hand into the product and work under nails spread remaining product evenly over the hands and lower 2/3 of one forearm paying particular attention to the nails, cuticles, and interdigital spaces place 2 mL of product into opposite hand and repeat steps ...

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Ethyl alcohol 70% v/v

Purpose

OTC - PURPOSE SECTION

Antiseptic surgical hand scrub

Uses

INDICATIONS & USAGE SECTION

Significantly reduces the number of micro-organisms on the hands and forearms prior to surgery or patient care

Warnings

WARNINGS SECTION

Flammable. Keep away from fire or flame.

For external use only

Sunburn Alert:This product contains an alpha hydroxy acid (AHA) that may increase the risk of sunburn. Take steps to limit sun exposure while using this product and for one week following use.

OTC - WHEN USING SECTION

Do not use in the eyes.In case of contact, rinse eyes thoroughly with water.

OTC - STOP USE SECTION

Stop use and ask a doctor ifirritation and redness develop and persist 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

  • clean under the nails with a nail pick
  • mails should be maintained with a 1 millimeter free edge
  • place 2 mL of product into palm of one hand
  • dip fingers of opposite hand into the product and work under nails
  • spread remaining product evenly over the hands and lower 2/3 of one forearm paying particular attention to the nails, cuticles, and interdigital spaces
  • place 2 mL of product into opposite hand and repeat steps above
  • allow to air dry completely

Inactive ingredients

INACTIVE INGREDIENT SECTION

Water (Aqua), Isopropyl Myristate, Glycerin, Diisopropyl Sebacate, Citric Acid, PEG/PPG-20/6 Dimethicone, Tetradibutyl Pentaerythrityl Hydroxyhydrocinnamate, Hydroxypropylcellulose, Polyquaternium-37, Methylchloroisothiazolinone, Methylisothiazolinone

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Product LabelProduct Label

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
582753ethanol 70 % Topical SolutionPSN4
582753ethanol 0.7 ML/ML Topical SolutionSCD4
582753ethanol 70 % Topical SolutionSY4
582753ethyl alcohol 70 % Topical SolutionSY4

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
21749-992-02PURELL Waterless Surgical Scrub59 mL in 1 BOTTLELIQUID594
21749-992-33PURELL Waterless Surgical Scrub1000 mL in 1 BOTTLELIQUID10004
21749-992-89PURELL Waterless Surgical Scrub1200 mL in 1 BOTTLELIQUID12004

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
21749-992PURELL WATERLESS SURGICAL SCRUB (ALCOHOL) LIQUID [GOJO INDUSTRIES, INC.]4Current NDC, Legacy NDC, 3 package rows20241218_e3ed5e0c-1e21-47eb-a999-9c8aa5083dff.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
ALCOHOLACTIVE INGREDIENT3K9958V90M1
ALCOHOLACTIVE MOIETY3K9958V90M1

Products#

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

DailyMed product names page 1 of 1 · 12 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
21749-99221749-992-02, 21749-992-33, 21749-992-89

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
WATER059QF0KO0RIACT
ISOPROPYL ALCOHOLND2M416302IACT
ISOPROPYL MYRISTATE0RE8K4LNJSIACT
GLYCERINPDC6A3C0OXIACT
DIISOPROPYL SEBACATEJ8T3X564IHIACT
CITRIC ACID MONOHYDRATE2968PHW8QPIACT
PENTAERYTHRITOL TETRAKIS(3-(3,5-DI-TERT-BUTYL-4-HYDROXYPHENYL)PROPIONATE)255PIF62MSIACT
HYDROXYPROPYL CELLULOSERFW2ET671PIACT
METHYLCHLOROISOTHIAZOLINONEDEL7T5QRPNIACT
METHYLISOTHIAZOLINONE229D0E1QFAIACT
ALCOHOL3K9958V90MACTIB

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
PURELL Waterless Surgical ScrubALCOHOLGOJO Industries, Inc.e3ed5e0c-1e21-47eb-a999-9c8aa5083dff2024-12-16WarningsExact identifier
ndc (package): 21749-992-33
ndc (package): 21749-992-02
ndc (package): 21749-992-89
ndc (product): 21749-992
ndc11 (package): 21749099202
ndc11 (package): 21749099289
ndc11 (package): 21749099233
spl id: 29676456-b1d3-defb-e063-6394a90a0091
spl set id: e3ed5e0c-1e21-47eb-a999-9c8aa5083dff

Reported adverse events (FAERS/openFDA)#

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