INDUSTRIAL FOAMING HAND SANITIZER- benzalkonium chloride aerosol, foam 
R & R Lotion, 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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Industrial Foaming Hand Sanitizer

Drug Facts

Active Ingredient

Benzalkonium Chloride 0.1%

Purpose

Antimicrobial

Uses

Warnings

For external use only

When using this product avoid contact with eyes. If contact with eyes, flush 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

Inactive Ingredients

DI Water, Cetrimonium Chloride, Laurtrimonium Chloride, Dihydroxyethyl Cocamine Oxide, Glycereth-17 Cocoate, Citric Acid

Questions or Comments

Call (480) 443-9255

PRINCIPAL DISPLAY PANEL - 591 ML Bottle Label

STRENGTH

INDUSTRIAL
FOAMING SANITIZER

KILLS GERMS

20 FL. OZ. (591ML) e

Principal Display Panel - 591 ML Bottle Label
INDUSTRIAL FOAMING HAND SANITIZER 
benzalkonium chloride aerosol, foam
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59555-402
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Benzalkonium Chloride (UNII: F5UM2KM3W7) (Benzalkonium - UNII:7N6JUD5X6Y) Benzalkonium Chloride1 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
Water (UNII: 059QF0KO0R)  
Cetrimonium Chloride (UNII: UC9PE95IBP)  
Laurtrimonium Chloride (UNII: A81MSI0FIC)  
Dihydroxyethyl Cocamine Oxide (UNII: 8AR51R3BL5)  
Glycereth-17 Cocoate (UNII: 3057VPT0KC)  
Citric Acid Monohydrate (UNII: 2968PHW8QP)  
Product Characteristics
ColorWHITEScore    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:59555-402-12591 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
2NDC:59555-402-113785 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product
3NDC:59555-402-1350 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 FINALpart333A12/21/2015
Labeler - R & R Lotion, Inc (062979000)

Revised: 12/2015
Document Id: 8b10430b-1e2a-4d05-bc0a-0d377cc51c88
Set id: e9db74b4-337a-4ae0-80bd-3f6014c34890
Version: 1
Effective Time: 20151204
 
R & R Lotion, Inc