Luvone Hand Antibacterial Roses
FDA Label NDC 80683-005
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Industrias Mc Clean S A S for the product Luvone Hand Antibacterial Roses (NDC 80683-005). 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 ingredients, purpose, use(s), warning(s), do not use, when using this product, stop use and ask a doctor if, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Active Ingredients
Benzalkonium Chlorie 0.13%
Purpose
Antibacterial
Use(S)
For hand washing to decrease bacteria on the skin.
Warning(S)
For external use only. Hands only.
Do Not Use
- In children less than 2 months of age.
- On open skin wounds.
When Using This Product
Avoid contact with eyes. In case of eye contact, flush with water.
Stop Use And Ask A Doctor If
irritation or redness develops. Conditions 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.
Directions
- Pum into hands, wet as nedeed.
- Lather vigorously for at least 15 seconds
- Wash skin, rinse thoroughly and dry.
Other Information
- Store at room temperature, in a cool and dry place.
Inactive Ingredients
Aqua, Cetrimonium Choride, Glycerin, Lauramidopropylamine Oxide, Cocamidopropyl betaine, Cocoamido MEA, Coco-Glucoside (and) Glyceryl Oleate, PEG-150 Distearate, Citric Acid, edetate disodium, Parfum, CI 17200.
Package Labeling:
Bottle4 (Bottle4)
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