Active Ingredients
Lidocaine
Hush Anesthetic Gel
FDA Label NDC 49947-002
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 49947-002). 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, warnings, uses, warnings, do not use, stop use and ask a doctor if, inactive ingredients, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Topical Anesthetic
Warnings
For external use only · Keep out of reach of children
Uses
Before skin is broken apply a thick layer of HUSH Gel in the area to be Tattooed. Spread evenly throughout. Reapply along the edges. Wrap the area with a plastic wrap and allow 1 hour for absorption. Remove the plastic wrap and prep skin for procedure.
Warnings
For external use only · Keep out of the reach of children
Do Not Use
In Blistered Areas · In the eyes · If allergic to ingredients
Stop Use And Ask A Doctor If
· skin becomes irritated · condition worsens or symptoms last more than 7 days · symptoms clear up and reoccur within a few days
Inactive Ingredients
Water, SD Alchohol 40B, Aloe Barbadensis Leaf Extract, Propylene Glycol, Triethanolamine, Glycerin, Menthol, Chamomile (Chamomilla Recutita) Flower Extract, Calendula Officinalis Flower Extract, Green Tea (Camellia Sinensis) Leaf Extract, Comfrey (Symphytum Officinale) Root Extract, Acrylates/c10-30 Alkyl Acrylate Crosspolymer, Disodium EDTA, Caprylyl Glycol, Methylisothiazolinone
Other Information
Questions or Comments? Call 305-231-7229 or visit www.HUSHgel.com
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