ROUGH AND SMOOTH HEAVY DUTY ANTISEPTIC HAND SANITIZER- benzalkonium chloride cloth 
Orbizorb LLC

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Rough and Smooth Heavy Duty Antiseptic Hand Sanitizer

Drug Facts

Active ingredient

Benzalkonium chloride 0.13%

Purpose

Antiseptic

Use

Warnings

For external use only

Do not use

in the eyes

Stop use and ask a doctor if

  • irritation and redness develop.
  • If condition persists for more than 72 hours consult a doctor.

Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center right away.

Directions

Inactive ingredients

Water, Estasol, Poloxalene, PEG-75 Lanolin, Glycerin, Aloe Barbadensis Extract, Polyethylene glycol, Lauryl Glycosides, Fragrance, Disodium EDTA, 2-bromo-2-nitropropane-1,3-diol, 1,2-benzisothiazolin-3-one.

Package Labeling:

Updated 80ct Label

Package Labeling:2wipes

Label

Package Labeling:40wipes

Label2

ROUGH AND SMOOTH HEAVY DUTY ANTISEPTIC HAND SANITIZER 
benzalkonium chloride cloth
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:90119-001
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE1.3 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
POLOXALENE (UNII: V8B3K56SW0)  
PEG-75 LANOLIN (UNII: 09179OX7TB)  
GLYCERIN (UNII: PDC6A3C0OX)  
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
LAURYL GLUCOSIDE (UNII: 76LN7P7UCU)  
EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)  
BRONOPOL (UNII: 6PU1E16C9W)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:90119-001-8080 in 1 CANISTER08/30/2020
1612.48 g in 1 PATCH; Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.)
2NDC:90119-001-022 in 1 PACKAGE09/20/2020
27.656 g in 1 PATCH; Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.)
3NDC:90119-001-4040 in 1 PACKAGE09/20/2020
37.656 g in 1 PATCH; Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.)
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph Drug505G(a)(3)08/30/2020
Labeler - Orbizorb LLC (117447551)

Revised: 10/2023
Document Id: 08aae52c-2d0c-377b-e063-6294a90a0635
Set id: ad67aa59-1fe5-0d75-e053-2995a90ac7e0
Version: 4
Effective Time: 20231026
 
Orbizorb LLC