ALCOHOL FREE HAND SANITIZER - benzalkonium chloride liquid 
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, Cetrimonium Chloride, Laurtrimonium Chloride, Dihydroxyethyl Cocamine Oxide, Glycereth-17 Cocoate, Citric Acid.

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Alcohol-free Hand Sanitizer

Powerful and Long Lasting I Gentle

1.69 FL OZ (50 mL)

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ALCOHOL FREE HAND SANITIZER 
benzalkonium chloride liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63002-005
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE0.13 g  in 100 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:63002-005-9950 mL in 1 BOTTLE; Type 0: Not a Combination Product03/11/2019
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A03/11/2019
Labeler - Advanced Hygienics LLC (065359009)
Establishment
NameAddressID/FEIBusiness Operations
Wisconsin Pharmacal Company800873986manufacture(63002-005)

Revised: 3/2019
Document Id: 43243be1-6fb3-40d0-8bea-a806bbf42eae
Set id: b9ff950e-bc8f-481b-8bd7-d41a675090ac
Version: 1
Effective Time: 20190311
 
Advanced Hygienics LLC