Active Ingredients
Lidocaine 4% w/w
Benzalkonium Chloride (0.13%) w/w
Hush Anesthetic
FDA Label NDC 49947-003
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Hush Anesthetic for the product Hush Anesthetic (NDC 49947-003). 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 active ingredients, purpose, uses, directions, warnings, otc - keep out of reach of children, otc - do not use, otc - stop use, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Pain Relieving Liquid
First Aid Antiseptic
Uses
First aid to help prevent bacterial contamination or skin infection and for temporary relief of pain and itching associated with minor cuts or minor skin irritations.
Directions
Adults and children 2 years of age and older: Apply to affected area not more than 3 to 4 times daily. Children under 2 years of age, consult a physician.
Warnings
For external use only • Avoid contact with the eyes
Otc - Keep Out Of Reach Of Children
Keep out of reach of children. If swallowed, get medical help right away or contact a Poison Control Center right away.
Otc - Do Not Use
Do not use in large quantities, particularly over raw surfaces or blistered areas
Otc - Stop Use
In case of deep or puncture wounds, animal bites, or serious bites, consult a doctor • If condition worsens, or if symptoms persist for more than 7 days or clear up and occur again within a few days, discontinue use of this product and consult a doctor
Inactive Ingredients
Aloe Barbadensis Leaf Extract, Aqua (Deionized Water), Calendula Officials Flower Extract, Caprylyl Glycol, Chamomile (Chamomilla Recutita) Flower Extract, Citric Acid, Cocamidopropyl Betaine, Comfrey (Symphytum Officinale) Root Extract, Disodium EDTA, Disodium Laureth Sulfosuccinate, Glycerin, Green Tea (Camellia Sinensis) Leaf Extract, Methylisothiazollnone, PEG-80 Sorbitan Laurate, Propylene Glycol
Other Information
Questions or Comments? Call 305-231-7229 or visit www.hushanesthetic.com
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