B4  HAND SANITIZER- ethyl alcohol 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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Drug Facts

Active ingredient

Ethyl Alcohol 62% w/w

Purpose

Antimicrobial

Uses

Warnings

FLAMMABLE

For external use only.

When using this product

Keep out of reach of children.

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

Directions


Other information

Inactive ingredients

Water, Aloe Vera Gel, Carbomer, Diisopropylamine, Glycerin, Isopropyl Myristate, Fragrance, Phenoxyethanol, Tocopheryl Acetate, D and C Yellow #10, FD and C Yellow #5, FD and C Blue #1

Distributed by

Midway Advanced Products, LLC
1-713-629-5200
800 Town and Country Blvd,  Suite 200, Houston, TX 77024

Principal Display Panel

B4

HAND SANITIZER
ENRICHED WITH ALOE
KILLS GERMS | ANTIBACTERIAL
Over 50% of after tax profits from B4
support Green and charitable causes.
B4products.com

Net 18.0 Fl Oz (532 ml)

Bottle Label

B4   HAND SANITIZER
ethyl alcohol gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:52490-100
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Alcohol (UNII: 3K9958V90M) (Alcohol - UNII:3K9958V90M) Alcohol42 mg  in 25 mL
Inactive Ingredients
Ingredient NameStrength
Water (UNII: 059QF0KO0R)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
CARBOMER HOMOPOLYMER TYPE C (UNII: 4Q93RCW27E)  
Diisopropylamine (UNII: BR9JLI40NO)  
Glycerin (UNII: PDC6A3C0OX)  
Isopropyl Myristate (UNII: 0RE8K4LNJS)  
Phenoxyethanol (UNII: HIE492ZZ3T)  
D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:52490-100-11532 mL in 1 BOTTLE, PUMP
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A09/15/2010
Labeler - Midway Advanced Products, LLC (962765009)

Revised: 3/2011
Document Id: d120f92e-5df5-4cde-a1ab-ff8c0eb77884
Set id: eb12fe9c-4050-4432-91a4-48792f29fa48
Version: 1
Effective Time: 20110324
 
Midway Advanced Products, LLC