GENRX ALL PURPOSE CLEANSING- benzalkonium chloride spray 
PureTek Corporation

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

Antiseptic

Uses

■ a no-rinse topical antiseptic that protects against bacterial contamination

Warnings

For external use only

Do not use on

■ deep or puncture wounds    ■ animal bites    ■ serious burns

When using this product

■ do not get into eyes

Stop use and ask a doctor if

■ condition worsens
■ symptoms last more than 7 days or clear up and occur again within a few days

Keep out of reach of children.

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

Directions

■ spray soiled and/or odorous (body and/or perineal) areas
■ gently wipe clean
■ repeat as necessary until all soils are removed and skin is clean    
■ pat dry (no rinsing necessary)
■ apply GenRx protectant cream or paste as necessary

Other information

■ protect from freezing    ■ avoid excessive heat

Inactive ingredients

Aloe barbadensis (Aloe vera) leaf juice, butylene glycol, disodium EDTA, fragrance, glycerin, GenRx Complex™ [consisting of: bisabolol, calcium pantothenate (vitamin B5), Carthamus tinctorius (safflower) oleosomes, maltodextrin, niacinamide (vitamin B3), pyridoxine HCl (vitamin B6), silica, sodium ascorbyl phosphate (vitamin C), sodium starch octenylsuccinate, tocopheryl acetate (vitamin E), Zingiber officinale (ginger) root extract], phenoxyethanol, polysorbate 20, purified water, sodium hyaluronate, sodium hydroxide.

GenRx All Purpose Cleansing Spray (8 oz label)

GenRx All Purpose Cleansing Spray 8 oz image

GENRX ALL PURPOSE CLEANSING 
benzalkonium chloride spray
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59088-543
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Benzalkonium Chloride (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) Benzalkonium Chloride1.3 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
GLYCERIN (UNII: PDC6A3C0OX)  
LEVOMENOL (UNII: 24WE03BX2T)  
CALCIUM PANTOTHENATE (UNII: 568ET80C3D)  
CARTHAMUS TINCTORIUS SEED OLEOSOMES (UNII: 9S60Q72309)  
MALTODEXTRIN (UNII: 7CVR7L4A2D)  
NIACINAMIDE (UNII: 25X51I8RD4)  
PYRIDOXINE HYDROCHLORIDE (UNII: 68Y4CF58BV)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
SODIUM ASCORBYL PHOSPHATE (UNII: 836SJG51DR)  
.ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8)  
GINGER (UNII: C5529G5JPQ)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
POLYSORBATE 20 (UNII: 7T1F30V5YH)  
WATER (UNII: 059QF0KO0R)  
HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
SODIUM HYDROXIDE (UNII: 55X04QC32I)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:59088-543-16237 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product01/08/201303/11/2019
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333E01/08/201303/11/2019
Labeler - PureTek Corporation (785961046)

Revised: 3/2019
Document Id: 519bc662-d877-4140-a8e0-ce4796e8612a
Set id: 7797c2ac-c1b1-459c-9114-f6cd0a4d5cf2
Version: 5
Effective Time: 20190311
 
PureTek Corporation