Drug Labeling and Warnings

Drug Details [pdf]

SAFE HANDS U-357- benzalkonium chloride soap 
Whisk Products, 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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Active Ingredient

Benzalkonium Chloride 0.13%

Purpose

Antimicrobial

Uses

  • For hand washing to decrease bacteria on the skin
  • Recommended for repeated use

Warnings

For external use only.

When using this product avoid contact with eyes.  In case of eye contact, flush eyes with water.

Stop use and ask a doctor if irritation or redness develops, 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 right away.

Directions

  • Pump a small amount of foam into palm of hand.
  • Rub thoroughly over all surfaces of both hands for fifteen seconds.
  • Rinse with potable water.

Inactive Ingredients

Water, Coco-Glucoside, Laurtrimonium Chloride, Cocamidopropylamine Oxide, Citric Acid

Case Label M-4

SAFE HANDS U-357 
benzalkonium chloride soap
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 65585-512
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)  
COCO GLUCOSIDE (UNII: ICS790225B)  
LAURTRIMONIUM CHLORIDE (UNII: A81MSI0FIC)  
COCAMIDOPROPYLAMINE OXIDE (UNII: M4SL82J7HK)  
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
Product Characteristics
Colorwhite (water-white, dispensed as a white foam) Score    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 65585-512-014 in 1 BOX06/26/201304/26/2019
14000 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333E06/26/201304/26/2019
Labeler - Whisk Products, Inc. (834270639)
Establishment
NameAddressID/FEIBusiness Operations
Whisk Products, Inc.834270639manufacture(65585-512)

Revised: 4/2019
Document Id: c0058791-b0c5-4384-8321-a7dd7355be5e
Set id: 72170827-cbec-401a-9fb9-c549024878fc
Version: 2
Effective Time: 20190426
 
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