Klean-Hands by Rite-Kem Incorporated KLEAN-HANDS liquid

Klean-Hands by

Drug Labeling and Warnings

Klean-Hands by is a Otc medication manufactured, distributed, or labeled by Rite-Kem Incorporated. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

COMPONENTS

Chloroxylenol 0.3%

PURPOSE

Antimicrobial Hand Soap

INDICATIONS & USAGE

Handwash to help decrease bacteria on the skin. Recommended for repeated use

WARNINGS

For external use only

DO NOT USE

When using this product do not use in or near the eyes. In case of contact, rinse eyes thoroughly with water.

STOP USE

Stop use and ask a doctor if irritation or rash appears and lasts

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

DOSAGE & ADMINISTRATION

Wet hands
Apply a small amount of product and work into a lather
Rinse well and dry hands completely

ACTIVE INGREDIENT

Chloroxylenol 0.3%

INACTIVE INGREDIENT

Dodecylbenzene sulfonic acid, triethanolamine salt, Cocoamidopropyl betaine, Glycerol, 1,3-propanediol, Ammonium lauryl sulfate, Coconut monoethanolamide, Sodium Chloride, Fragrance, Dye, Water

Label

Klean-Hands Antimicrobial Hand soap

Formulated for food service and health care professionals who wash hands frequently and require the protection of an antimicrobial soap.

FDA registered

Made in USA

* Utilize the quickacting antimicrobial agent (PCMX) to kill germs

* Pleasing agent

* Powerful degreasers

* Soothing to the skin

* Ideal schools, health clubs, offices and recreation areas

* Rich Lather

* High foam enhances cleaning

* Performs equally well in hand and soft water

* Conditions as it cleans

Sold by: Rite-Kem Inc., 703 Westmoreland Drive, Tupelco, MS 38801

Ph.: 662-840-6060

NDC: 73943-948-xx

INGREDIENTS AND APPEARANCE

KLEAN-HANDS 
klean-hands liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 73943-948
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
CHLOROXYLENOL (UNII: 0F32U78V2Q) (CHLOROXYLENOL - UNII:0F32U78V2Q)	CHLOROXYLENOL	0.3 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
TROLAMINE (UNII: 9O3K93S3TK)
GLYCERIN (UNII: PDC6A3C0OX)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
COCO MONOETHANOLAMIDE (UNII: C80684146D)
LAVENDER OIL (UNII: ZBP1YXW0H8)
PROPANEDIOL (UNII: 5965N8W85T)
AMMONIUM LAURYL SULFATE (UNII: Q7AO2R1M0B)
DODECYLBENZENESULFONIC ACID (UNII: 60NSK897G9)
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)

Product Characteristics
Color		Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 73943-948-01	354 mL in 1 BOTTLE; Type 0: Not a Combination Product	09/18/2020
2	NDC: 73943-948-02	3785 mL in 1 BOTTLE; Type 0: Not a Combination Product	09/18/2020
3	NDC: 73943-948-03	18927 mL in 1 BOTTLE; Type 0: Not a Combination Product	09/18/2020
4	NDC: 73943-948-04	208198 mL in 1 BOTTLE; Type 0: Not a Combination Product	09/18/2020
5	NDC: 73943-948-05	236 mL in 1 BOTTLE; Type 0: Not a Combination Product	02/08/2021

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	09/18/2020

Labeler - Rite-Kem Incorporated (786892927)

Establishment
Name	Address	ID/FEI	Business Operations
Rite-Kem Incorporated		786892927	manufacture(73943-948)