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Name:Alcohol Swabstick
Manufacturer:Dynarex Corporation
Category:Over-the-counter (OTC) Marketed Drugs


Alcohol Swabstick & Pads

ALCOHOL SWABSTICK  - isopropyl alcohol swab 
Dynarex Corporation

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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Alcohol Swabstick & Pads

Active Ingredient                                       Purpose

Isopropyl Alcohol 70% v/v                         Antiseptic


Use:

For preparation of the skin prior to injection.

Warnings:

  • For external use only
  • Flammable, keep away from flame or fire
  • Not for use with electrocautinary devices or procedures
  • Do not use in eyes

Indications and Usage:

Stop use and ask a doctor if:

  • Irritation or redness develops
  • condition persists for more than 72 hours
  • Cleansing of an injection site

Keep out of reach of children.

In case of accidental ingestion, seek professional assistance or consult a poison control center immediately.

Directions:

Wipe injection site vigorously and discard

Other information:

  • Store at room temperature: 15 deg C to 30 deg C   59 deg F to 86 deg F
  • avoid excessive heat

Inactive Ingredient

Inactive Ingredient

  • Water

Principal Display Alcohol Swabstick

Principal Display

Alcohol_Swabstick


ALCOHOL SWABSTICK 
alcohol swabstick swab
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:67777-120
Route of Administration TOPICAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ISOPROPYL ALCOHOL (ISOPROPYL ALCOHOL) ISOPROPYL ALCOHOL 1.4 mL
Inactive Ingredients
Ingredient Name Strength
WATER  
Product Characteristics
Color      Score     
Shape Size
Flavor Imprint Code
Contains     
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:67777-120-10 10 BOX ( BOX) in 1 CASE contains a BOX
1 50 SWAB ( SWAB) in 1 BOX This package is contained within the CASE (67777-120-10)
2 NDC:67777-120-09 10 BOX ( BOX) in 1 CASE contains a BOX
2 75 SWAB ( SWAB) in 1 BOX This package is contained within the CASE (67777-120-09)
3 NDC:67777-120-03 20 BOX ( BOX) in 1 CASE contains a BOX
3 100 SWAB ( SWAB) in 1 BOX This package is contained within the CASE (67777-120-03)
4 NDC:67777-120-04 10 BOX ( BOX) in 1 CASE contains a BOX
4 200 SWAB ( SWAB) in 1 BOX This package is contained within the CASE (67777-120-04)
5 NDC:67777-120-05 10 BOX ( BOX) in 1 CASE contains a BOX
5 100 SWAB ( SWAB) in 1 BOX This package is contained within the CASE (67777-120-05)
6 NDC:67777-120-13 20 BOX ( BOX) in 1 CASE contains a BOX
6 200 SWAB ( SWAB) in 1 BOX This package is contained within the CASE (67777-120-13)

Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph final part344 03/01/2010

Labeler - Dynarex Corporation (008124539)
Registrant - Dynarex Corporation (008124539)
Establishment
Name Address ID/FEI Operations
Nantong Strip Medical Supply Co., Ltd 546585519 manufacture
Establishment
Name Address ID/FEI Operations
Sion Biotext Medical Ltd 532775194 manufacture
Establishment
Name Address ID/FEI Operations
Taizhou Kanglin Health Porduces Co. Ltd 530576131 manufacture
Establishment
Name Address ID/FEI Operations
Shanghai Yinjing Medical SuppliesCo., Ltd. 530501535 manufacture

Revised: 03/2011 Dynarex Corporation



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


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