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Name:Benzoin
Manufacturer:James Alexander Corporation
Category:Over-the-counter (OTC) Marketed Drugs


Drug Facts

BENZOIN  - benzoin, aloe, tolu balsam and liquidambar styraciflua resin swab 
James Alexander Corporation

Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

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Drug Facts

active ingredients each swab purpose
100 percent compound benzoin tincture usp topical bandage adhesive

uses an adhesive to hold bandages in place

warnings for external use only
allergy alert if you have had a history of contact with benzoin compounds
When using this product avoid getting in the wound

if swallowed get medical help or contact a Poison Control Center right away

an adhesive to hold bandages in place
when using this product avoid getting in the wound

clean and dry skin around the wound
gently squeeze vial to crush inner ampoule
allow tincture to saturate the tip of the vial and carefully apply a thin film of the tincture to the skin on each side of the wound allow tincture to dry 30 to 40 seconds before applying bandages

Alcohol

cmpound benzoin tincture usp dispensing solutions
James Alexander
compound outer label

BENZOIN 
benzoin swab
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:46414-8888
Route of Administration TOPICAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Benzoin (Benzoin) Benzoin 0.6 g  in 0.6 mL
Aloe (ALOE VERA LEAF) Aloe .12 g  in .12 mL
TOLU BALSAM (BALSAM PERU) TOLU BALSAM .24 g  in .24 mL
LIQUIDAMBAR STYRACIFLUA RESIN (LIQUIDAMBAR STYRACIFLUA RESIN) LIQUIDAMBAR STYRACIFLUA RESIN .48 g  in .48 mL
Inactive Ingredients
Ingredient Name Strength
Alcohol  
Product Characteristics
Color      Score     
Shape Size
Flavor Imprint Code
Contains     
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:46414-8888-2 60 mL in 1 BOX None

Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
unapproved drug other 10/25/1976

Labeler - James Alexander Corporation (040756421)
Registrant - James Alexander Corporation (040756421)
Establishment
Name Address ID/FEI Operations
James Alexander Corporation 040756421 manufacture

Revised: 04/2011 James Alexander Corporation



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


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