SD KLEEN RX HAND SANITIZER GEL

Manufacturer: Spa Dent Inc.
Effective date: 2020-08-11
Label type: HUMAN OTC DRUG LABEL
Version: 2
Source: full-release
Hydrated at: 2026-05-31 23:24:26

Label at a glance#

ProductSD KLEEN RX HAND SANITIZER

Active ingredientALCOHOL

Label structure12 sections

Dosage and administration

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

Label contents#

Full prescribing information#

ACTIVE INGREDIENT

OTC - ACTIVE INGREDIENT SECTION

Alcohol 70% v/v

PURPOSE

OTC - PURPOSE SECTION

Antiseptic

USE(S)

INDICATIONS & USAGE SECTION

• Antiseptic (skin) cleanser • Medicated (skin) cleanser • Antibacterial (skin) cleanser • Effective in destroying (harmful) bacteria to provide antiseptic cleansing • For personal hand hygiene to help prevent the spread of bacteria

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 under 6 years of age when using this product to avoid swallowing.

Other Information

SPL UNCLASSIFIED SECTION

Store between 15° - 30 °C (59° - 85°F) out of direct sunlight.
Avoid freezing and excessive heat above 40° C (104° F).

Do not use this product if tamper-resistant seal is broken when opened.

Inactive ingredients

INACTIVE INGREDIENT SECTION

Water, Glycerin, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Aminomethyl propanol, Aloe barbadensis Leaf Juice, dl-alpha Tocopheryl acetate

Package Labeling:

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Bottle3

79147-002-01

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Label2

79147-002-02

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Label3

79147-002-03

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Label4

79147-002-04

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Label5

79147-002-05

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Label6

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
79147-002-01	2023-01-30	C162847	48780-1	f386c649-c04a-0266-e053-dadaa90a7c1a	SD KLEEN RX HAND SANITIZER GEL
79147-002-02	2023-01-30	C162847	48780-1	f386c649-c04a-0266-e053-dadaa90a7c1a	SD KLEEN RX HAND SANITIZER GEL
79147-002-03	2023-01-30	C162847	48780-1	f386c649-c04a-0266-e053-dadaa90a7c1a	SD KLEEN RX HAND SANITIZER GEL
79147-002-04	2023-01-30	C162847	48780-1	f386c649-c04a-0266-e053-dadaa90a7c1a	SD KLEEN RX HAND SANITIZER GEL
79147-002-05	2023-01-30	C162847	48780-1	f386c649-c04a-0266-e053-dadaa90a7c1a	SD KLEEN RX HAND SANITIZER GEL
79147-002-33	2023-01-30	C162847	48780-1	f386c649-c04a-0266-e053-dadaa90a7c1a	SD KLEEN RX HAND SANITIZER GEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
79147-002-01	SD KLEEN RX HAND SANITIZER	59 mL in 1 BOTTLE	SOLUTION	59		2
79147-002-02	SD KLEEN RX HAND SANITIZER	236 mL in 1 BOTTLE, PUMP	SOLUTION	236		2
79147-002-03	SD KLEEN RX HAND SANITIZER	473 mL in 1 BOTTLE, PUMP	SOLUTION	473		2
79147-002-04	SD KLEEN RX HAND SANITIZER	946 mL in 1 BOTTLE, PUMP	SOLUTION	946		2
79147-002-05	SD KLEEN RX HAND SANITIZER	3780 mL in 1 BOTTLE	SOLUTION	3780		2
79147-002-33	SD KLEEN RX HAND SANITIZER	1000 mL in 1 BOTTLE, PUMP	SOLUTION	1000		2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
79147-002	SD KLEEN RX HAND SANITIZER (ALCOHOL) SOLUTION [SPA DENT INC.]	2	Legacy NDC, 6 package rows	20200812_aaa5dee3-6924-db4c-e053-2995a90ab540.zip

Products#

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

DailyMed product names page 1 of 1 · 8 matching rows.

SD KLEEN RX HAND SANITIZER
ALCOHOL
WATER
GLYCERIN
CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED)
AMINOMETHYLPROPANOL
ALOE VERA LEAF
.ALPHA.-TOCOPHEROL ACETATE, DL-

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
79147-002	79147-002-33, 79147-002-01, 79147-002-02, 79147-002-03, 79147-002-04, 79147-002-05

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 7 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
WATER	059QF0KO0R	IACT
GLYCERIN	PDC6A3C0OX	IACT
CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED)	59TL3WG5CO	IACT
AMINOMETHYLPROPANOL	LU49E6626Q	IACT
ALOE VERA LEAF	ZY81Z83H0X	IACT
.ALPHA.-TOCOPHEROL ACETATE, DL-	WR1WPI7EW8	IACT
ALCOHOL	3K9958V90M	ACTIB

Source Document#

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
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
ac9f1c06-b388-24fa-e053-2a95a90a86e0			aaa5dee3-6924-db4c-e053-2995a90ab540	2020-08-11	Warnings	Exact identifier spl id: ac9f1c06-b388-24fa-e053-2a95a90a86e0 spl set id: aaa5dee3-6924-db4c-e053-2995a90ab540

Reported adverse events (FAERS/openFDA)#

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