B4 HAND SANITIZER ALCOHOL-FREE- benzalkonium chloride gel 
MIDWAY ADVANCED PRODUCTS 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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B4 HAND SANITIZER ALCOHOL FREE

DRUG FACTS
ACTIVE INGREDIENTS

BENZALKONIUM CHLORIDE 0.13%

PURPOSE

ANTIMICROBIAL

USES

to sanitize hands without water

kills 99% of most common bacteria

WARNINGS

For external use only.

WHEN USING

When using this product

Do not use in the eyes

Discontinue use if irritation or redness develop

KEEP OUT OF REACH OF CHILDREN

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

DIRECTIONS

Tear open packet and apply entire amount of gel to unsoild hands

Rub in thoroughly until hands are dry.

Do not rub or use water rinse

OTHER INFORMATION

store at room temperature

INACTIVE INGREDIENTS

Water, Butylene Glycol, Glycerin, Caeesolpinia Spinosa Gum, Sodium Lauryl Sulfate, Fragrance.

DISTRIBUTED BY

Midway Advanced Products

800 Town & Country Blvd., Suite 200

Houston, TX 77024

888.238.9284

PRODUCT LABELING

Label1

label2

B4 HAND SANITIZER ALCOHOL-FREE 
benzalkonium chloride gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:52490-300
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE1.3 mg  in 100 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
CAESALPINIA SPINOSA RESIN (UNII: WL3883U2PO)  
GLYCERIN (UNII: PDC6A3C0OX)  
SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:52490-300-0715 mL in 1 TUBE; Type 0: Not a Combination Product10/21/201512/01/2017
2NDC:52490-300-06500 in 1 BOX10/21/201512/01/2017
21.2 mL in 1 PACKET; Type 0: Not a Combination Product
3NDC:52490-300-272000 in 1 BOX10/21/201512/01/2017
32 mL in 1 PACKET; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333E10/21/201512/01/2017
Labeler - MIDWAY ADVANCED PRODUCTS LLC (962765009)

Revised: 12/2017
Document Id: 5fc47cf3-56ab-7807-e053-2a91aa0ac541
Set id: 22a10ee9-d617-3639-e054-00144ff8d46c
Version: 3
Effective Time: 20171207
 
MIDWAY ADVANCED PRODUCTS LLC