SS-455 SPRING SPRUCE HAND SANITIZING REFILL- benzalkonium chloride swab 
Ez Products Of South Florida, LLC

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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SS-455 Spring Spruce Hand Sanitizing Wipe Refill

Drug Facts

Active Ingredient

Benzalkonium Chloride (BZK) 0.13%

Purpose

Antimicrobial

Uses

  • Hand sanitizer to help reduce bacteria on the skin

Warnings

For external use only.

When using this product

do not use in or near the eyes. In case of contact, rinse thoroughly with water.

Stop use and ask a doctor if

if irritation or rash appears and lasts.

Keep out of reach of children.

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

Directions

  • Wet hands thoroughly with product and allow to dry
  • Children under 6 years of age should be supervised when using this product

Inactive ingredients

Water (Aqua), Gluconolactone, Sodium Benzoate, Chlorhexidine Digluconate, Cetylpyridinium Chloride, Sodium Citrate

Package Labeling:

Label2

SS-455 SPRING SPRUCE HAND SANITIZING REFILL 
benzalkonium chloride swab
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69446-201
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE0.13 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
GLUCONOLACTONE (UNII: WQ29KQ9POT)  
SODIUM BENZOATE (UNII: OJ245FE5EU)  
CHLORHEXIDINE GLUCONATE (UNII: MOR84MUD8E)  
CETYLPYRIDINIUM CHLORIDE (UNII: D9OM4SK49P)  
SODIUM CITRATE (UNII: 1Q73Q2JULR)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:69446-201-001500 in 1 POUCH12/17/201712/18/2017
11.25 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 not finalpart333E12/17/201712/18/2017
Labeler - Ez Products Of South Florida, LLC (113456060)

Revised: 11/2018
Document Id: 7bd26081-160f-216c-e053-2991aa0afc33
Set id: 664ab52d-60f4-a8c8-e053-2a91aa0a7c40
Version: 2
Effective Time: 20181129
 
Ez Products Of South Florida, LLC