CLn Hypochlorous Spray 8.5 fl oz

GUDID 00856447003674

Hypochlorous Acid, HOCL, 0.013% solution

TOPMD SKIN CARE, INC.

Antimicrobial wound irrigation solution
Primary Device ID00856447003674
NIH Device Record Key5744d5e2-ab14-4692-b09a-9e1d1cbfbeb9
Commercial Distribution StatusIn Commercial Distribution
Brand NameCLn Hypochlorous Spray 8.5 fl oz
Version Model Number3674-85
Company DUNS060946293
Company NameTOPMD SKIN CARE, INC.
Device Count1
DM Exemptfalse
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 Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Countertrue

Customer Support Contacts

Phone877-992-7425
Emailsupport@clnwash.com
Phone877-992-7425
Emailsupport@clnwash.com
Phone877-992-7425
Emailsupport@clnwash.com
Phone877-992-7425
Emailsupport@clnwash.com
Phone877-992-7425
Emailsupport@clnwash.com
Phone877-992-7425
Emailsupport@clnwash.com
Phone877-992-7425
Emailsupport@clnwash.com
Phone877-992-7425
Emailsupport@clnwash.com
Phone877-992-7425
Emailsupport@clnwash.com
Phone877-992-7425
Emailsupport@clnwash.com
Phone877-992-7425
Emailsupport@clnwash.com
Phone877-992-7425
Emailsupport@clnwash.com
Phone877-992-7425
Emailsupport@clnwash.com

Device Dimensions

Total Volume8.5 Fluid Ounce
Total Volume8.5 Fluid Ounce
Total Volume8.5 Fluid Ounce
Total Volume8.5 Fluid Ounce
Total Volume8.5 Fluid Ounce
Total Volume8.5 Fluid Ounce
Total Volume8.5 Fluid Ounce
Total Volume8.5 Fluid Ounce
Total Volume8.5 Fluid Ounce
Total Volume8.5 Fluid Ounce
Total Volume8.5 Fluid Ounce
Total Volume8.5 Fluid Ounce
Total Volume8.5 Fluid Ounce

Operating and Storage Conditions

Special Storage Condition, SpecifyBetween 0 and 0 *Store at room temperature away from direct sunlight and heat. Thaw and shake the contents before use if frozen.
Special Storage Condition, SpecifyBetween 0 and 0 *Store at room temperature away from direct sunlight and heat. Thaw and shake the contents before use if frozen.
Special Storage Condition, SpecifyBetween 0 and 0 *Store at room temperature away from direct sunlight and heat. Thaw and shake the contents before use if frozen.
Special Storage Condition, SpecifyBetween 0 and 0 *Store at room temperature away from direct sunlight and heat. Thaw and shake the contents before use if frozen.
Special Storage Condition, SpecifyBetween 0 and 0 *Store at room temperature away from direct sunlight and heat. Thaw and shake the contents before use if frozen.
Special Storage Condition, SpecifyBetween 0 and 0 *Store at room temperature away from direct sunlight and heat. Thaw and shake the contents before use if frozen.
Special Storage Condition, SpecifyBetween 0 and 0 *Store at room temperature away from direct sunlight and heat. Thaw and shake the contents before use if frozen.
Special Storage Condition, SpecifyBetween 0 and 0 *Store at room temperature away from direct sunlight and heat. Thaw and shake the contents before use if frozen.
Special Storage Condition, SpecifyBetween 0 and 0 *Store at room temperature away from direct sunlight and heat. Thaw and shake the contents before use if frozen.
Special Storage Condition, SpecifyBetween 0 and 0 *Store at room temperature away from direct sunlight and heat. Thaw and shake the contents before use if frozen.
Special Storage Condition, SpecifyBetween 0 and 0 *Store at room temperature away from direct sunlight and heat. Thaw and shake the contents before use if frozen.
Special Storage Condition, SpecifyBetween 0 and 0 *Store at room temperature away from direct sunlight and heat. Thaw and shake the contents before use if frozen.
Special Storage Condition, SpecifyBetween 0 and 0 *Store at room temperature away from direct sunlight and heat. Thaw and shake the contents before use if frozen.

Device Identifiers

Device Issuing AgencyDevice ID
GS100856447003674 [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 Date2025-12-09
Device Publish Date2025-12-01

Devices Manufactured by TOPMD SKIN CARE, INC.

00856447003629 - CLn Hypochlorous Spray 3 fl oz2025-12-09 Hypochlorous Acid, HOCL, 0.013% solution
00856447003674 - CLn Hypochlorous Spray 8.5 fl oz2025-12-09Hypochlorous Acid, HOCL, 0.013% solution
00856447003674 - CLn Hypochlorous Spray 8.5 fl oz2025-12-09 Hypochlorous Acid, HOCL, 0.013% solution

© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.