PURELOGIC FOAMING HAND SANITIZER FRENCH LAVENDER- benzalkonium chloride solution 
Argento sc by sicura inc.

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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AB0028 FL foaming

Active Ingredient(s)

Benzalkonium Chloride 0.13%

Purpose: 

Antibacterial

Use

Hand sanitizer to help reduce bacteria on skin that could cause disease

Recommended for repeated use

Warnings

For external use on hands only.

When using this product

When using this product, keep out of eyes. In case of contact with eyes, flush thoroughly with water

Do not ingest or inhale

Avoid contact with broken skin

Stop use and ask a doctor

if irrigation and redness develop 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 immediately

Directions

Other information

To prevent discoloration, avoid contact with clothing

Inactive ingredients

Water, Sodium lauroamphoacetate, Cocamidopropylamine oxide, Cocamidopropyl betaine, Glycerin, Olea europaea (olive) leaf extract, Polyminopropyl biguanide, Citric acid, Disodium EDTA, Benzophenone-3, Methylchloroisothiazolinone, Methylisothiazolinone, Fragrance, Cetylpyridinium chloride, Red 33 (CI17200), Blue 1 (CI42090)

image description

PURELOGIC FOAMING HAND SANITIZER FRENCH LAVENDER 
benzalkonium chloride solution
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:77731-055
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE0.13 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
SODIUM LAUROAMPHOACETATE (UNII: SLK428451L)  
COCAMIDOPROPYLAMINE OXIDE (UNII: M4SL82J7HK)  
WATER (UNII: 059QF0KO0R)  
D&C RED NO. 33 (UNII: 9DBA0SBB0L)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
GLYCERIN (UNII: PDC6A3C0OX)  
OLEA EUROPAEA LEAF (UNII: MJ95C3OH47)  
CETYLPYRIDINIUM CHLORIDE (UNII: D9OM4SK49P)  
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
DISODIUM HEDTA (UNII: KME849MC7A)  
BENZOPHENONE (UNII: 701M4TTV9O)  
METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN)  
METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:77731-055-01500 mL in 1 BOTTLE; Type 0: Not a Combination Product07/31/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A07/31/2020
Labeler - Argento sc by sicura inc. (168718778)

Revised: 8/2020
Document Id: abd41285-dafc-14a4-e053-2a95a90af6ea
Set id: 174fd0e5-9969-4275-9f21-29a81bd3fa86
Version: 1
Effective Time: 20200801
 
Argento sc by sicura inc.