SD KLEEN RX HAND SANITIZER- alcohol solution

SD KLEEN RX HAND SANITIZER by

Drug Labeling and Warnings

SD KLEEN RX HAND SANITIZER by is a Otc medication manufactured, distributed, or labeled by Spa Dent Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active Ingredient(s)

Alcohol 80% v/v

Purpose

Antiseptic

Use(s)

Hand Sanitizer to help reduce bacteria that potentially can cause disease. For use when soap and water are not available.

Warnings

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

Do not use

- in children less than 2 months of age

- on open skin wounds

When using this product

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

Stop use and ask a doctor 

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

Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center right away.

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 Information

- Store between 10-30 °C (59-85°F)

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

Inactive ingredients

glycerin, hydrogen peroxide, purified water USP

Package Labeling:

INGREDIENTS AND APPEARANCE

SD KLEEN RX HAND SANITIZER 
alcohol solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 79147-001
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	0.8 mL  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
GLYCERIN (UNII: PDC6A3C0OX)
HYDROGEN PEROXIDE (UNII: BBX060AN9V)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 79147-001-33	1000 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	06/22/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333E	06/22/2020

Labeler - Spa Dent Inc. (203478896)

Establishment
Name	Address	ID/FEI	Business Operations
Spa Dent Inc.		203478896	manufacture(79147-001)