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.

----------

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 Type HUMAN OTC DRUG Item Code (Source) NDC:59088-543
Route of Administration TOPICAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Benzalkonium Chloride (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) Benzalkonium Chloride 1.3 mg  in 1 mL
Inactive Ingredients
Ingredient Name Strength
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 Code Package Description Marketing Start Date Marketing End Date
1 NDC:59088-543-16 237 mL in 1 BOTTLE, SPRAY
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part333E 01/08/2013
Labeler - PureTek Corporation (785961046)

Revised: 1/2013
Document Id: cc97b2a3-19d0-4e18-a410-1df167aa70e4
Set id: 7797c2ac-c1b1-459c-9114-f6cd0a4d5cf2
Version: 4
Effective Time: 20130108
 
PureTek Corporation