ALCOHOL - isopropyl alcohol swab
Sion Biotext Medical Ltd

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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Active Ingredient Purpose

Isopropyl Alcohol 70% v/v Antiseptic

Uses: alcohol

Antiseptic cleanser.

Warnings:

FOR EXTERNAL USE ONLY

Do not use:

In the eyes.
With electrocautery procedures.

Stop use and ask a doctor:

If irritation and redness develop
If condition persists for more than 72 hours, consult a physician.

Keep Out Of Reach Of Children

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

Directions:

Tear at notch, remove swab, use only once.

Wipe injection site vigorously and discard.

Inactive Ingredient:

Inactive Ingredient: Water

Indications and Usage:

For use as an

antiseptic

Principal display panel

Sion Sterile Alcohol Prep Pad

Sion_sterile_alcohol_prep_pad

ALCOHOL
alcohol swab

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:68786-120
Route of Administration	TOPICAL	DEA Schedule

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ISOPROPYL ALCOHOL (ISOPROPYL ALCOHOL)	ISOPROPYL ALCOHOL	0.7 mL in 1 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:68786-120-14	20 BOX ( BOX) in 1 CASE	contains a BOX
1		100 POUCH ( POUCH) in 1 BOX	This package is contained within the CASE (68786-120-14) and contains a POUCH
1		3 mL in 1 POUCH	This package is contained within a BOX and a CASE (68786-120-14)
2	NDC:68786-120-13	10 BOX ( BOX) in 1 CASE	contains a BOX
2		200 POUCH ( POUCH) in 1 BOX	This package is contained within the CASE (68786-120-13) and contains a POUCH
2		3 mL in 1 POUCH	This package is contained within a BOX and a CASE (68786-120-13)
3	NDC:68786-120-16	10 BOX ( BOX) in 1 CASE	contains a BOX
3		100 POUCH ( POUCH) in 1 BOX	This package is contained within the CASE (68786-120-16) and contains a POUCH
3		3 mL in 1 POUCH	This package is contained within a BOX and a CASE (68786-120-16)

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part344	12/19/2011

Labeler - Sion Biotext Medical Ltd (532775194)

Revised: 12/2011 Sion Biotext Medical Ltd