Alcohol by Sion Biotext Medical Ltd / Sion Biotext Mexico SAPI de CV ALCOHOL swab

Alcohol by

Drug Labeling and Warnings

Alcohol by is a Otc medication manufactured, distributed, or labeled by Sion Biotext Medical Ltd, Sion Biotext Mexico SAPI de CV. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredient

Isopropyl Alcohol 70% v/v

Purpose

Antiseptic

Uses

First aid to help prevent infection in minor cuts, scrapes and burns

For preparation of the skin prior to an injection

Warnings

• For external use only
• Flammable, keep away from flame or fire

Do not use

• in the eyes or over large areas of the body
• longer than 1 week unless directed by doctor
• with electrocautery procedures

Ask a doctor before use if you have

deep or puncture wounds, animal bites or serious burns

Stop use an ask a doctor if

conditions persists for more than 72 hours or gets worse

Keep out of reach of children.

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

Directions:

• When used for first aid: Clean the affected area. Apply a small amount of this product on the area 1 to 3 times daily. May be covered with a sterile bandage. If bandaged, let dry first.
• When used to prepare an injection site: Apply product to the injection site prior to injection.

Other Information:

• Store at room temperature
• Avoid excessive heat

Inactive Ingredient

Water

Principal Display Panel

NDC: 68786-300-01

4'' saturated

50 individual packs

NDC: 68786-300-02

4" saturated

3 per packet

25 packet

INGREDIENTS AND APPEARANCE

ALCOHOL 
alcohol swab

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 68786-300
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: 68786-300-01	10 in 1 CASE	10/09/2020
1		50 in 1 BOX
1		1 in 1 POUCH
1		1.4 mL in 1 PATCH; Type 0: Not a Combination Product
2	NDC: 68786-300-02	10 in 1 CASE	10/09/2020
2		75 in 1 BOX
2		3 in 1 POUCH
2		1.4 mL in 1 PATCH; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M003	10/09/2020

Labeler - Sion Biotext Medical Ltd (532775194)

Registrant - Sion Biotext Mexico SAPI de CV (951575186)