SANI SMART ALOE FORMULA ANTIBACTERIAL- benzalkonium chloride soap 
K7 Design Group 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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SANI SMART Antibacterial Hand Soap

Active Ingredient

Benzalkonium Chloride 0.13%

Purpose

Antiseptic

Use

for hand-washing to decrease bacteria on the skin.

Warnings

For external use only

When using this product

■ do not get into eyes.

■ if contact occurs, rinse eyes thoroughly with water.

Stop use and ask a doctor if

■ irritation and redness develops

Keep out of reach of children

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

Directions

■ Squeeze into hands and lather with water. Rinse well

Inactive ingredients

Water, Sodium Laureth Sulfate, Cocamidopropyl Betaine, Sodium Chloride, Glyceryl Laurate, Phenoxyethanol, Fragrance, PEG-150 Distearate, Aloe Barbadensis Leaf Juice, Disodium EDTA, Citric Acid, Magnesium Chloride, Methylchloroisothiazolinone, Magnesium Nitrate, Methylisothiazolinone

Package Label

Package Label

SANI SMART ALOE FORMULA  ANTIBACTERIAL
benzalkonium chloride soap
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:74177-002
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
METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)  
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
PEG-150 DISTEARATE (UNII: 6F36Q0I0AC)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
MAGNESIUM NITRATE (UNII: 77CBG3UN78)  
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
MAGNESIUM CHLORIDE (UNII: 02F3473H9O)  
METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN)  
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
WATER (UNII: 059QF0KO0R)  
GLYCERYL LAURATE (UNII: Y98611C087)  
SODIUM LAURETH SULFATE (UNII: BPV390UAP0)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:74177-002-08236 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product04/22/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A04/22/2020
Labeler - K7 Design Group Inc. (080357784)

Revised: 4/2020
Document Id: a4486701-017a-7b8e-e053-2a95a90af7d3
Set id: a44866c8-aa2e-3f8d-e053-2995a90a46c5
Version: 1
Effective Time: 20200427
 
K7 Design Group Inc.