Neosalus Lotion

GUDID 00381811000022

NEOSALUS Lotion is a fragrance-free, water-soluble dressing formulated for the management and relief of irritation experienced with various types of dermatoses including atopic dermatitis and allergic contact dermatitis. NEOSALUS Lotion is intended for topical application.

Resilia Pharmaceuticals, Inc.

Dry skin moisture barrier dressing
Primary Device ID00381811000022
NIH Device Record Key3ebaf572-61d4-4eee-9d67-9cae521fb2e0
Commercial Distribution StatusIn Commercial Distribution
Brand NameNeosalus Lotion
Version Model Number1
Company DUNS117711487
Company NameResilia Pharmaceuticals, Inc.
Device Count1
DM Exempttrue
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone404-446-1391
Emailmleone@resiliapharma.com
Phone404-446-1391
Emailmleone@resiliapharma.com
Phone404-446-1391
Emailmleone@resiliapharma.com
Phone404-446-1391
Emailmleone@resiliapharma.com
Phone404-446-1391
Emailmleone@resiliapharma.com
Phone404-446-1391
Emailmleone@resiliapharma.com
Phone404-446-1391
Emailmleone@resiliapharma.com
Phone404-446-1391
Emailmleone@resiliapharma.com
Phone404-446-1391
Emailmleone@resiliapharma.com
Phone404-446-1391
Emailmleone@resiliapharma.com
Phone404-446-1391
Emailmleone@resiliapharma.com
Phone404-446-1391
Emailmleone@resiliapharma.com
Phone404-446-1391
Emailmleone@resiliapharma.com
Phone404-446-1391
Emailmleone@resiliapharma.com
Phone404-446-1391
Emailmleone@resiliapharma.com
Phone404-446-1391
Emailmleone@resiliapharma.com
Phone404-446-1391
Emailmleone@resiliapharma.com
Phone404-446-1391
Emailmleone@resiliapharma.com
Phone404-446-1391
Emailmleone@resiliapharma.com
Phone404-446-1391
Emailmleone@resiliapharma.com
Phone404-446-1391
Emailmleone@resiliapharma.com
Phone404-446-1391
Emailmleone@resiliapharma.com
Phone404-446-1391
Emailmleone@resiliapharma.com
Phone404-446-1391
Emailmleone@resiliapharma.com
Phone404-446-1391
Emailmleone@resiliapharma.com
Phone404-446-1391
Emailmleone@resiliapharma.com
Phone404-446-1391
Emailmleone@resiliapharma.com
Phone404-446-1391
Emailmleone@resiliapharma.com
Phone404-446-1391
Emailmleone@resiliapharma.com

Device Dimensions

Weight226.7 Gram
Weight226.7 Gram
Weight226.7 Gram
Weight226.7 Gram
Weight226.7 Gram
Weight226.7 Gram
Weight226.7 Gram
Weight226.7 Gram
Weight226.7 Gram
Weight226.7 Gram
Weight226.7 Gram
Weight226.7 Gram
Weight226.7 Gram
Weight226.7 Gram
Weight226.7 Gram
Weight226.7 Gram
Weight226.7 Gram
Weight226.7 Gram
Weight226.7 Gram
Weight226.7 Gram
Weight226.7 Gram
Weight226.7 Gram
Weight226.7 Gram
Weight226.7 Gram
Weight226.7 Gram
Weight226.7 Gram
Weight226.7 Gram
Weight226.7 Gram
Weight226.7 Gram

Operating and Storage Conditions

Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS100381811000022 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

FRODressing, Wound, Drug

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2024-06-21
Device Publish Date2024-06-13

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00381811000022 - Neosalus Lotion2024-06-21NEOSALUS Lotion is a fragrance-free, water-soluble dressing formulated for the management and relief of irritation experienced with various types of dermatoses including atopic dermatitis and allergic contact dermatitis. NEOSALUS Lotion is intended for topical application.
00381811000022 - Neosalus Lotion2024-06-21 NEOSALUS Lotion is a fragrance-free, water-soluble dressing formulated for the management and relief of irritation experienced w
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