HAND SANITIZER - benzalkonium chloride solution 
Advanced Hygienics LLC

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

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 the reach of children.

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

Directions

Pump a small amount of foam onto hands.

Rub thoroughly over all surfaces of both hands.

Rub hands together briskly until dry.

Inactive ingredients

Water, Polyaminopropyl Biguanide, C8-10 Alkyl Polyglucoside, C12-15 Pareth-7, Dimethicone, Cetrimomium Chloride, Laurtrimonium Chloride, Dihydroxyethyl Cocamine Oxide, Glycereth-17 Cocoate, Citric Acid

Questions?

1-866-443-4509

American

Red Cross

Always Ready

Hand Sanitizer

Antibacterial Foaming

Alcohol-Free

Powerful and Long Lasting

Gentle

16.9 FL OZ (500 mL)

container label

HAND SANITIZER 
benzalkonium chloride solution
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63002-004
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE1.3 g  in 1 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
POLIHEXANIDE (UNII: 322U039GMF)  
CAPRYLYL GLUCOSIDE (UNII: V109WUT6RL)  
C12-15 PARETH-7 (UNII: 3XY03A79QH)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
CETRIMONIUM CHLORIDE (UNII: UC9PE95IBP)  
LAURTRIMONIUM CHLORIDE (UNII: A81MSI0FIC)  
DIHYDROXYETHYL COCAMINE OXIDE (UNII: 8AR51R3BL5)  
GLYCERETH-17 COCOATE (UNII: 3057VPT0KC)  
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:63002-004-339.76 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product05/18/2017
2NDC:63002-004-9950 mL in 1 BOTTLE; Type 0: Not a Combination Product05/18/2017
3NDC:63002-004-50500 mL in 1 BOTTLE; Type 0: Not a Combination Product05/18/2017
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A05/18/2017
Labeler - Advanced Hygienics LLC (065359009)
Establishment
NameAddressID/FEIBusiness Operations
Wisconsin Pharmacal Company800873986manufacture(63002-004)

Revised: 5/2017
Document Id: bfc689ba-d7f8-4c16-9a13-4bd7b859bbf5
Set id: 1b225968-aff7-4959-89e1-a8edabb4d670
Version: 2
Effective Time: 20170522
 
Advanced Hygienics LLC