STAY SAFE HAND SANITIZER ALCOHOL FREE- benzalkonium chloride gel 
Denison Pharmaceuticals, 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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Active ingredient

Benzalkonium Chloride 0.13%

Purpose

Antimicrobial

Uses:

  • For hand sanitizing to decrease bacteria and viruses on the skin
  • Recommended for repeated use

Warnings

For external use only

When using this product avoid contact with eyes. In case of contact flush eyes with water.

Stop use or ask a doctor if irritation or redness develops or if condition persists for more than 72 hours

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away

Directions

Pump a small amount of liquid into palm of hand • Rub thoroughly over all surfaces on both hands for 15 seconds • Rinse with potable water (Optional)

Other Information

Avoid excessive heat

Inactive Ingredients

Purified water, Aloe Vera Gel 10:1 Concentrate, Edetate Disodium Dihydrate USP, Igepal CO-630, Propylene Glycol

label

STAY SAFE HAND SANITIZER ALCOHOL FREE 
benzalkonium chloride gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0295-9049
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE0.13 mg  in 100 mL
Inactive Ingredients
Ingredient NameStrength
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
NONOXYNOL-9 (UNII: 48Q180SH9T)  
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0295-9049-23177.441 mL in 1 BOTTLE; Type 0: Not a Combination Product04/27/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A04/27/2020
Labeler - Denison Pharmaceuticals, LLC (001207208)
Establishment
NameAddressID/FEIBusiness Operations
Denison Pharmaceuticals, LLC001207208manufacture(0295-9049)

Revised: 4/2020
Document Id: a44b9fb7-87e4-2185-e053-2a95a90a5b6e
Set id: a44b9fb7-87e3-2185-e053-2a95a90a5b6e
Version: 1
Effective Time: 20200427
 
Denison Pharmaceuticals, LLC