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

Key Label Information#

Active Ingredients And Purpose

Active Ingredient(s)

Alcohol 80% v/v

Uses

Use(s)

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

Warnings

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

Directions And Dosage

Directions

- 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 Label Information

Inactive ingredients

glycerin, hydrogen peroxide, purified water USP

Package Labeling:

Label Images#

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	SPL version
1039339	ethanol 80 % Topical Solution	PSN	1
1039339	ethanol 0.8 ML/ML Topical Solution	SCD	1
1039339	ethanol 80 % Topical Solution	SY	1

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
79147-000-33	2023-01-30	C162847	48780-1	f386c649-f2d5-0266-e053-dadaa90a7c1a	SD KLEEN RX ANTISEPTIC HAND RUB

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
79147-000-33	SD KLEEN RX ANTISEPTIC HAND RUB	1000 mL in 1 BOTTLE, PUMP	SOLUTION	1000		1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
79147-000	SD KLEEN RX ANTISEPTIC HAND RUB (ALCOHOL) SOLUTION [SPA DENT INC.]	1	Legacy NDC, 1 package rows	20200718_aaa5a12e-b60e-26f3-e053-2995a90aa2b0.zip

Products#

SD KLEEN RX ANTISEPTIC HAND RUB

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
79147-000	79147-000-33

Ingredients#

Name, UNII, Kind table
Name	UNII	Kind
GLYCERIN	PDC6A3C0OX	IACT
HYDROGEN PEROXIDE	BBX060AN9V	IACT
WATER	059QF0KO0R	IACT
ALCOHOL	3K9958V90M	ACTIB

Complete SPL Sections#

Drug Facts

SPL UNCLASSIFIED SECTION

Active Ingredient(s)

OTC - ACTIVE INGREDIENT SECTION

Alcohol 80% v/v

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

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

Source Document#

Source XML