Drug Labeling and Warnings

Drug Details [pdf]

GOOD CLEAN SUDS ANTIBACTERIAL FOAM HAND- benzalkonium chloride soap 
Zorin Pharmaceutical Technology (Hangzhou) Co Ltd.

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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Drug Facts

Active ingredient

Benzalkonium Chloride ................. 0.13%

Purpose

Antibacterial

USE

For handwashing to decrease bacteria on skin.

Warnings

For external use only.

When using this product

keep out of eyes, if contact with eyes occurs, rinse thoroughly with water.

Stop use and ask a doctor

if irritation and rash develops.

Keep out of reach of children.

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

Directions

  • Wet hands
  • Apply foaming soap to hands and work into rich lather.
  • Rinse hands thoroughly.

Inactive ingredients

Disodium Cocoamphodiacetate, Water, Glycerin, Citric Acid, EDTA-2Na, CAB-35, Fragrance

package

label image

GOOD CLEAN SUDS ANTIBACTERIAL FOAM HAND 
benzalkonium chloride soap
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 75183-101
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
WATER (UNII: 059QF0KO0R)  
GLYCERIN (UNII: PDC6A3C0OX)  
DISODIUM COCOAMPHODIACETATE (UNII: 18L9G3U51M)  
ANHYDROUS TRISODIUM CITRATE (UNII: RS7A450LGA)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 75183-101-01259 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product11/20/202011/23/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333E11/20/202011/23/2020
Labeler - Zorin Pharmaceutical Technology (Hangzhou) Co Ltd. (554529819)
Establishment
NameAddressID/FEIBusiness Operations
Zorin Pharmaceutical Technology (Hangzhou) Co Ltd.554529819manufacture(75183-101)

Revised: 11/2020
 
Zorin Pharmaceutical Technology (Hangzhou) Co Ltd.