Defnse Antiseptic Hand Sanitizer
FDA Label NDC 77846-888
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Lusty Libation Ltd. for the product Defnse Antiseptic Hand Sanitizer (NDC 77846-888). 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 drug facts, active ingredient, purpose, uses, warnings, otc - keep out of reach of children, directions, other information, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Active Ingredient
Ethyl alcohol 70%
Purpose
Antiseptic
Uses
- hand sanitizer to decrease bacteria on the skin
- recommended for repeated use
- for use when soap and water are not available
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
- irritation and redness develop
- condition persists for more than 72 hours
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
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.
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
Other Information
- store between 15-30°C (59-86°F)
- avoid freezing and excessive heat above 40°C (104°F)
Inactive Ingredients
denatonium benzoate, fragrance, glycerin, hydrogen peroxide, hydroxyethyl cellulose, water
Questions?
You may also report serious side effects to this phone number.
Mon-Fri 9:00 AM - 5:00 PM
Other
HOLISTIC LIVING
NPN: 80099248
Manufactured by: Lusty Libation Inc. 620 Supertest Rd., Unit 5, Toronto, ON, Canada M3J 2M5
Product of Canada.
www.holisticlivingltd.com
Packaging
Untitled (77846 888 1)
Untitled (77846 888 2)
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