Your browser does not support JavaScript! SANISUDS FOAM HAND SANITIZER (BENZALKONIUM CHLORIDE) SOAP [PALMER FIXTURE COMPANY]
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SANISUDS FOAM HAND SANITIZER (benzalkonium chloride) soap
[Palmer Fixture Company]


Category DEA Schedule Marketing Status
HUMAN OTC DRUG LABEL OTC monograph not final
NOTE: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.
Drug Label Sections

Active Ingredient

Benzalkonium Chloride 0.1%

Purpose

Antimicrobial

Uses

  • For hand sanitizing 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.
  • Rub hands together briskly until dry.

Inactive Ingredients

Water, cetrimonium chloride, laurtrimonium chloride, dihydroxyethyl cocamine oxide, glycereth-17 cocoate, citric acid, fragrance

Case Label - 3 x 1200 mL Bags

SANISUDS FOAM HAND SANITIZER 
benzalkonium chloride soap
Product Information
Product TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:48417-750
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Benzalkonium Chloride (Benzalkonium) Benzalkonium Chloride1.00 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
WATER 
CETRIMONIUM CHLORIDE 
LAURTRIMONIUM CHLORIDE 
DIHYDROXYETHYL COCAMINE OXIDE 
CITRIC ACID MONOHYDRATE 
GLYCERETH-17 COCOATE 
Product Characteristics
Colorwhite (water white - colorless, dispensed as a white foam) Score    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:48417-750-023 in 1 BOX
11200 mL in 1 BAG
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333E04/07/2009
Labeler - Palmer Fixture Company (185454241)

Revised: 3/2014
 
Palmer Fixture Company

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