Klean +tm

Klean +tm
SPL v1
SPL
SPL Set ID 96515326-b808-4b83-b922-7696b00669c1
Route
TOPICAL
Published
Effective Date 2020-04-10
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Alcohol (65 mL)
Inactive Ingredients
Water Coconut Oil Xanthan Gum Glycerin Methylparaben Sodium Propylparaben Edetate Sodium Tea Tree Oil

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2020-04-06

Description

Active ingredient Ethanol 65%


Medication Information

Warnings and Precautions

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

Indications and Usage

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

Dosage and 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

Description

Active ingredient Ethanol 65%

Section 42229-5

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:

[email protected]

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

Made in Vietnam

Section 44425-7

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

Section 50565-1

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

Section 51727-6

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

Section 53413-1

Questions? +1-800-674-3263



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

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

Section 55105-1

Purpose

Antiseptic

Section 55106-9

Active ingredient

Ethanol 65%

Packaging


Structured Label Content

Indications and Usage (34067-9)

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

Dosage and Administration (34068-7)

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

Warnings and Precautions (34071-1)

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

Section 42229-5 (42229-5)

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:

[email protected]

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

Made in Vietnam

Section 44425-7 (44425-7)

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

Section 50565-1 (50565-1)

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

Section 51727-6 (51727-6)

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

Section 53413-1 (53413-1)

Questions? +1-800-674-3263



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

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

Section 55105-1 (55105-1)

Purpose

Antiseptic

Section 55106-9 (55106-9)

Active ingredient

Ethanol 65%

Packaging


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)