PREVANTICS MAXI SWABSTICK- chlorhexidine gluconate and isopropyl alcohol solution

Prevantics Maxi Swabstick by

Drug Labeling and Warnings

Prevantics Maxi Swabstick by is a Otc medication manufactured, distributed, or labeled by Professional Disposables International, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredients

Chlorhexidine gluconate 3.15% w/v

Isopropyl alcohol 70% v/v

Purposes

Antiseptic

Antiseptic

Use

for the preparation of the patient's skin prior to surgery or injection

Warnings

• For external use only
• Flammable, keep away from fire or flame
• Do not use with electrocautery procedures

Allergy alert

This product may cause a severe allergic reaction. Symptoms may include:

• wheezing/difficulty breathing
• shock
• facial swelling
• hives
• rash

If an allergic reaction occurs, stop use and seek medical help right away.

Do not use

• on patients allergic to chlorhexidine gluconate or any other ingredient in this product
• for lumbar puncture or in contact with the meninges
• on open skin wounds or as a general skin cleanser
• under occlusive patch

When using this product

keep out of eyes, ears, mouth and mucous membranes. May cause serious or permanent injury if permitted to enter and remain.

If contact occurs, rinse with cold water right away and contact a doctor.

Stop use and ask a doctor if

irritation, sensitization, or allergic reaction occurs. These may be signs of a serious condition.

Keep out of reach of children.

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

Directions

• use with care in premature infants or infants under 2 months of age. These products may cause irritation or chemical burns.
• maximum treatment area for one maxi swabstick is approximately: dry site: 7 by 7 inches (18 by 18 cm) or moist site: 3 by 7.5 inches (7.5 by 19 cm)
• open the pouch to expose the swabstick
• remove swabstick from package. Do not touch the foam tip.
• prior to surgery or injection, apply one flat side of foam tip to the proposed skin site and prep the skin in vigorous back-and-forth repeated strokes , turning the swabstick over (unused side of the foam tip) hlf way in the procedure
• dry site: scrub repeatedly back and forth for 15 seconds with each side of the applicator for a total of 30 seconds. Allow to air dry for approximately 30 seconds.
• moist site: scrub repeatedly back and forth for 1 minute with each side of the applicator for a total of 2 minutes. Allow to air dry for approximately 1.5 minutes.
• do not blot or wipe dry
• discard after a single use

Other information

• store between 68-77°F (20-25°C)
• avoid freezing and excessive heat above 104°F (40°C)
• for hospital and professional use only

Inactive ingredients

USP purified water

Package/Label Principal Display Panel

Prevantics(R) Maxi Swabstick
[Chlorhexidine Gluconate (3.15%) and Isopropyl Alcohol (70%) Swab]

Patient preoperative skin preparation
Non-sterile solution

• For external use only
• Single step, broad spectrum, persistent antiseptic that significantly reduces the number of microorganisms on intact skin
• Use for the preparation of the patient's skin prior to surgery or injection
• Helps reduce bacteria that potentially can cause skin infection
• Latex free
• For hospital and professional use only

IMPORTANT: See carton for complete Drug Factsand safety information.

Packet Label

Box Label

Packet (bulk):

Insert:

INGREDIENTS AND APPEARANCE

PREVANTICS MAXI SWABSTICK 
chlorhexidine gluconate and isopropyl alcohol solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 10819-4076
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
CHLORHEXIDINE GLUCONATE (UNII: MOR84MUD8E) (CHLORHEXIDINE - UNII:R4KO0DY52L)	CHLORHEXIDINE GLUCONATE	31.5 mg  in 1 mL
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: 10819-4076-4	30 in 1 BOX	01/01/2020
1		5.1 mL in 1 POUCH; Type 0: Not a Combination Product
2	NDC: 10819-4076-3	300 in 1 CASE	01/01/2020
2		5.1 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
NDA	NDA021524	01/01/2020

Labeler - Professional Disposables International, Inc. (800777117)

Establishment
Name	Address	ID/FEI	Business Operations
Professional Disposables International, Inc.		800777117	manufacture(10819-4076)