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Name:Native Green Foaming Hand Sanitizer
Manufacturer:Native Green
Category:Over-the-counter (OTC) Marketed Drugs


Drug Facts

NATIVE GREEN FOAMING HAND SANITIZER - benzalkonium chloride solution 
Native Green

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 0.1%

Purpose

Antimicrobial

Uses

  • For hand sanitizing to decrease bacteria on the skin

Warning

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

Directions

  • Pump a small amount of foam into palm of hand
  • Rub thoroughly over all surfaces of both hands
  • Rub hands together briskly until dry

Inactive Ingredients Water, dihydroxpropyl PEG-5
linoleammonium chloride, glycereth-2 cocoate, behentrimonium
chloride, dihydroxyethyl cocamine oxide, fragrance

Principal Display Panel – Bottle Label

NATIVE GREEN
FOAMING HAND SANITIZER
ALCOHOL-FREE – WITH MOISTURIZERS

Cleaner, Greener

SEE SIDE PANEL FOR ADDITIONAL INFORMATION.

Principal Display Panel – Bottle Label

NATIVE GREEN FOAMING HAND SANITIZER 
benzalkonium chloride solution
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:50409-514
Route of Administration TOPICAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
benzalkonium chloride (benzalkonium) benzalkonium chloride 1 g  in 1000 mL
Inactive Ingredients
Ingredient Name Strength
water  
dihydroxypropyl peg-5 linoleammonium chloride  
glycereth-2 cocoate  
behentrimonium chloride  
dihydroxyethyl cocamine oxide  
Product Characteristics
Color      Score     
Shape Size
Flavor Imprint Code
Contains     
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:50409-514-82 550 mL in 1 BOTTLE None
2 NDC:50409-514-42 50 mL in 1 BOTTLE None

Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part333 04/21/2010

Labeler - Native Green (791610038)
Establishment
Name Address ID/FEI Operations
Canberra Corporation 068080621 MANUFACTURE

Revised: 04/2010 Native Green



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


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