Otc - Active Ingredient
Active ingredient
Ethanol 65%
Klean Plus Instant Hand Sanitizer Tea Tree Scent
FDA Label NDC 74025-444
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Catchers International Limited Liability Company for the product Klean Plus Instant Hand Sanitizer Tea Tree Scent (NDC 74025-444). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding otc - active ingredient, otc - purpose, indications & usage, warnings, otc - keep out of reach of children, dosage & administration, storage and handling, inactive ingredient, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - 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
Otc - 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
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
Otc - 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
Other
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:
Manufactured for: Klean + Hand Sanitizer, PO Box 9751 225 S Broadway, Denver, CO 80209
Made in Vietnam
Packaging
Klean1 (Kleanw)
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