SD KLEEN RX ANTISEPTIC HAND RUB

Manufacturer
Spa Dent Inc.
Effective date
2020-07-17
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:21:49

Label at a glance#

ProductSD KLEEN RX ANTISEPTIC HAND RUB
Active ingredientALCOHOL
Label structure7 sections

Dosage and administration

- Place enough product on hands to cover all surfaces. Rub hands together until dry. - Supervise children 6 years of age when using this product to avoid swallowing.

Label contents#

Full prescribing information#

Active Ingredient(s)

OTC - ACTIVE INGREDIENT SECTION

Alcohol 80% v/v

Purpose

OTC - PURPOSE SECTION

Antiseptic

Use(s)

INDICATIONS & USAGE SECTION

Health care personnel hand rub to help reduce bacteria that potentially can cause disease.

Warnings

WARNINGS SECTION

For External use only. Flammable. Keep away from heat or flame

Do not use

OTC - DO NOT USE SECTION

- in children less than 2 months of age

- on open skin wounds

When using this product

OTC - WHEN USING SECTION

keep out of eyes, ears and mouth. In case of contact with eyes, rise eyes thoroughly with water.

Stop use and ask a doctor 

OTC - STOP USE SECTION

if irritation or rash occurs. These may be signs of a serious condition.

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 enough product on hands to cover all surfaces. Rub hands together until dry.

- Supervise children 6 years of age when using this product to avoid swallowing.

Other Information

SPL UNCLASSIFIED SECTION

- Store between 10-30 °C (59-85°F)

- Avoid freezing and excessive heat above 40°C (104°F)

Inactive ingredients

INACTIVE INGREDIENT SECTION

glycerin, hydrogen peroxide, purified water USP

Package Labeling:

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

BottleBottle

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1039339ethanol 80 % Topical SolutionPSN1
1039339ethanol 0.8 ML/ML Topical SolutionSCD1
1039339ethanol 80 % Topical SolutionSY1

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
79147-000-332023-01-30C16284748780-1f386c649-f2d5-0266-e053-dadaa90a7c1aSD KLEEN RX ANTISEPTIC HAND RUB

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
79147-000-33SD KLEEN RX ANTISEPTIC HAND RUB1000 mL in 1 BOTTLE, PUMPSOLUTION10001

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
79147-000SD KLEEN RX ANTISEPTIC HAND RUB (ALCOHOL) SOLUTION [SPA DENT INC.]1Legacy NDC, 1 package rows20200718_aaa5a12e-b60e-26f3-e053-2995a90aa2b0.zip

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
79147-00079147-000-33

Ingredients#

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

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

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
aaa5a12e-b60f-26f3-e053-2995a90aa2b0aaa5a12e-b60e-26f3-e053-2995a90aa2b02020-07-17WarningsExact identifier
spl id: aaa5a12e-b60f-26f3-e053-2995a90aa2b0
spl set id: aaa5a12e-b60e-26f3-e053-2995a90aa2b0

Reported adverse events (FAERS/openFDA)#

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