Active ingredients

Chlorhexidine gluconate 3.15% w/v

Isopropyl alcohol 70% v/v

Purpose

Antiseptic

Use

for the preparation of the patient's skin prior to an 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 swab is approximately 2.5 by 2.5 inches (6 by 6 cm)
tear open packet and remove swab. Do not unfold swab.
prior to injection, apply swab to the procedure site by holding swab between thumb and index finger. Apply swab to skin using repeated back-and-forth strokes for 15 seconds.
allow the prepped area to air dry for 30 seconds
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

Reorder No. B10800
NDC 10819-1080-1

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

Antiseptic

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 an injection
Helps reduce bacteria that potentially can cause skin infection
Latex free
For hospital and professional use only

IMPORTANT: See carton for complete Drug Facts and safety information.

Packet Label packet

Box Label box

PREVANTICS SWAB
chlorhexidine gluconate and isopropyl alcohol solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:10819-1080
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
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

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

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:10819-1080-1	100 in 1 BOX	01/15/2013
1		1 mL in 1 POUCH; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
NDA	NDA021524	01/15/2013

Labeler - Professional Disposables International, Inc. (800777117)

Name	Address	ID/FEI	Business Operations
Establishment
Professional Disposables International, Inc.		800777117	manufacture(10819-1080)

B10800 NDC 10819-1080-1