KLEAN ANTISEPTIC HAND SANITIZER- ethyl alcohol spray

Klean Antiseptic Hand Sanitizer by

Drug Labeling and Warnings

Klean Antiseptic Hand Sanitizer by is a Otc medication manufactured, distributed, or labeled by CATCHERS INTERNATIONAL LIMITED LIABILITY COMPANY. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active ingredient

Ethyl alcohol 67%

Purpose

Antiseptic

INDICATIONS & USAGE

Uses    hand sanitizer to decrease bacteria on the skin    recommended for repeated use   for use when soap and water are not available

WARNINGS

Warnings

 Flammable, keep away from fire/flame

For external use only

Do not use    in children less than 2 months of age   on open skin wounds

When using this product    do not get into eyes. In case of contact, rinse eyes thoroughly with water

Stop use and ask a doctor if    irritation and redness develop    condition persists for more than 72 hours

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

DOSAGE & ADMINISTRATION

Directions wet hands thoroughly with product and allow to dry without wiping    supervise children under 6 years of age when using this product to avoid swallowing

STORAGE AND HANDLING

Other information     store between 15-30°C (59-86°F)     avoid freezing and excessive heat above 40C (104F)

INACTIVE INGREDIENT

Inactive ingredients  didecyldimethylammonium chloride, eucalyptus oil, lavender oil, rosemary oil, water

QUESTIONS

Questions? +1-800-674-3263

You may also report serious effects to this phone number. Mon-Fri 9:00 AM - 5:00 PM

SPL UNCLASSIFIED SECTION

GUARANTEED NATURAL & PURE

CRISP LAVENDER

KLEANER

For A Healthier Life

67% Ethyl Alcohol

Hand Crafted In Small Batches Designed for Daily Use

Manufactured for: Klean + Hand Sanitizer, PO Box 9751, 225 S Broadway, Denver, CO 80209

Made in Vietnam

Packaging

INGREDIENTS AND APPEARANCE

KLEAN ANTISEPTIC HAND SANITIZER 
ethyl alcohol spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 74025-777
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	0.67 mL  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
DIDECYLDIMONIUM CHLORIDE (UNII: JXN40O9Y9B)
EUCALYPTUS OIL (UNII: 2R04ONI662)
LAVENDER OIL (UNII: ZBP1YXW0H8)
ROSEMARY OIL (UNII: 8LGU7VM393)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 74025-777-50	50 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product	03/26/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	03/26/2020

Labeler - CATCHERS INTERNATIONAL LIMITED LIABILITY COMPANY (556673620)

Establishment
Name	Address	ID/FEI	Business Operations
CATCHERS INTERNATIONAL LIMITED LIABILITY COMPANY		556673620	manufacture(74025-777)