KLEAN PLUS INSTANT HAND SANITIZER TEA TREE SCENT- ethanol gel

KLEAN PLUS INSTANT HAND SANITIZER TEA TREE SCENT by

Drug Labeling and Warnings

KLEAN PLUS INSTANT HAND SANITIZER TEA TREE SCENT 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

Active ingredient

Ethanol 65%

PURPOSE

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

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

When using this product 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 40°C (104°F)  tamper evident

INACTIVE INGREDIENT

Inactive ingredients water, extra virgin coconut oil, xanthan gum, glycerin, nipagin, nipasol, EDTA-4Na, tea tree essential oil

QUESTIONS

Questions? +1-800-674-3263

You may also report serious side effects to this phone number.

Mon-Fri 9:00 AM - 5:00 PM

SPL UNCLASSIFIED SECTION

KLEANER For A Healthier Life

ANTIBACTERIAL

TEA TREE SCENT

hand crafted in small batches designed for daily use 

Distributed by:

Chiavaye LLC

Denver, CO 80209

kleanhandsanitizer.com

Customer Service:

support@kleanhandsanitizer.com

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

Made in Vietnam

Packaging

INGREDIENTS AND APPEARANCE

KLEAN PLUS INSTANT HAND SANITIZER TEA TREE SCENT 
ethanol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 74025-444
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	65 mL  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
COCONUT OIL (UNII: Q9L0O73W7L)
XANTHAN GUM (UNII: TTV12P4NEE)
GLYCERIN (UNII: PDC6A3C0OX)
METHYLPARABEN SODIUM (UNII: CR6K9C2NHK)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
EDETATE SODIUM (UNII: MP1J8420LU)
TEA TREE OIL (UNII: VIF565UC2G)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 74025-444-90	90 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	04/06/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	04/06/2020

Labeler - CATCHERS INTERNATIONAL LIMITED LIABILITY COMPANY (556673620)

Establishment
Name	Address	ID/FEI	Business Operations
CATCHERS INTERNATIONAL LIMITED LIABILITY COMPANY		556673620	manufacture(74025-444)