alcohol by Sion Biotext Medical Ltd ALCOHOL swab

alcohol by

Drug Labeling and Warnings

alcohol by is a Otc medication manufactured, distributed, or labeled by Sion Biotext Medical Ltd. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

​Active Ingredient

Isopropyl Alcohol 70% v/v                         

Purpose

Antiseptic

Uses

For preparation of skin prior to an injection

Warnings:

• For External Use Only
• Flammable, keep away from fire or flame
• Sterile unless pouch is opened or damaged

Do not use:

• With electrocautery procedures
• In the eyes.

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:

• Wipe injection site vigorously and discard.

Other Information

• Avoid excessive heat
• Store at room temperature 15o​-30o C (59o-86o F)

Inactive Ingredients

Water

Principal display panel

NDC: 68786-120-13

Sion Biotext Medical Ltd.

Alcohol Prep Pad

Sterile- Medium 2 Ply

One pad saturated with 70% Isopropyl Alcohol

INGREDIENTS AND APPEARANCE

ALCOHOL 
alcohol swab

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

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ISOPROPYL ALCOHOL (UNII: ND2M416302) (ISOPROPYL ALCOHOL - UNII:ND2M416302)	ISOPROPYL ALCOHOL	0.7 mL  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 68786-120-14	20 in 1 CASE	12/19/2011
1		100 in 1 BOX
1		3 mL in 1 POUCH; Type 0: Not a Combination Product
2	NDC: 68786-120-13	10 in 1 CASE	12/19/2011
2		200 in 1 BOX
2		3 mL in 1 POUCH; Type 0: Not a Combination Product
3	NDC: 68786-120-16	10 in 1 CASE	12/19/2011
3		100 in 1 BOX
3		3 mL in 1 POUCH; Type 0: Not a Combination Product

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)

Registrant - Sion Biotext Medical Ltd (532775194)

Establishment
Name	Address	ID/FEI	Business Operations
Sion Biotext Medical Ltd		532775194	manufacture(68786-120)