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Name:B4 Hand Sanitizer
Manufacturer:Midway Advanced Products, Llc
Category:Over-the-counter (OTC) Marketed Drugs


Drug Facts

B4  HAND SANITIZER - 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

  • To sanitize hands without water.
  • Kills 99% of most common bacteria.

Warnings

FLAMMABLE

For external use only.

When using this product

  • keep away from fire or flame.
  • 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 unsoiled hands.
  • rub in thoroughly until hands are dry.
  • do not wipe or use water rinse.

Other information

  • Store at room temperature.

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

packet label - front
packet label - back

Principal Display Panel - Box

B4
HAND SANITIZER
A Healthy Beginning to Every Meal
Contains 25 single-use liquid packets
1.2 ml per packet (total 30 mls)
ENRICHED WITH ALOE | KILLS GERMS | ANTIBACTERIAL

Box label - front


B4   HAND SANITIZER
ethyl alcohol gel
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:52490-100
Route of Administration TOPICAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Alcohol (Alcohol) Alcohol 42 mg  in 25 mL
Inactive Ingredients
Ingredient Name Strength
Water  
ALOE VERA LEAF  
CARBOMER HOMOPOLYMER TYPE C  
Diisopropylamine  
Glycerin  
Isopropyl Myristate  
Phenoxyethanol  
D&C YELLOW NO. 10  
FD&C YELLOW NO. 5  
FD&C BLUE NO. 1  
Product Characteristics
Color      Score     
Shape Size
Flavor Imprint Code
Contains     
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:52490-100-12 25 PACKET ( PACKET) in 1 BOX contains a PACKET
1 1.2 mL in 1 PACKET This package is contained within the BOX (52490-100-12)
2 NDC:52490-100-13 50 PACKET ( PACKET) in 1 BOX contains a PACKET
2 1.2 mL in 1 PACKET This package is contained within the BOX (52490-100-13)
3 NDC:52490-100-14 100 PACKET ( PACKET) in 1 BOX contains a PACKET
3 1.2 mL in 1 PACKET This package is contained within the BOX (52490-100-14)

Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part333A 09/15/2010

Labeler - Midway Advanced Products, LLC (962765009)

Revised: 04/2011 Midway Advanced Products, LLC



Source: http://dailymed.nlm.nih.gov
Reproduced with permission of U.S. National Library of Medicine


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