PREVANTICS MAXI SWABSTICK- chlorhexidine gluconate and isopropyl alcohol solution 
Professional Disposables International, Inc.

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S27350- NDC 10819-4076-3
S41950- NDC-10819-4076-4

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

To reduce the risk of fire, PREP CAREFULLY:

​​​

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

Other information

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

Packaging is sterile when in sterile kit

*equivalent to 161 mg of Chlorhexidine Gluconate per pouch

IMPORTANT: See carton for complete Drug Factsand safety information.

Packet Label

packet 1

Box Label

box 1

Packet (bulk):

Packet 2

Insert:

Product Insert

PREVANTICS MAXI SWABSTICK 
chlorhexidine gluconate and isopropyl alcohol solution
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:10819-4076
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CHLORHEXIDINE GLUCONATE (UNII: MOR84MUD8E) (CHLORHEXIDINE - UNII:R4KO0DY52L) CHLORHEXIDINE GLUCONATE31.5 mg  in 1 mL
ISOPROPYL ALCOHOL (UNII: ND2M416302) (ISOPROPYL ALCOHOL - UNII:ND2M416302) ISOPROPYL ALCOHOL0.7 mL  in 1 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:10819-4076-430 in 1 BOX12/01/2023
15.1 mL in 1 POUCH; Type 0: Not a Combination Product
2NDC:10819-4076-3300 in 1 CASE09/01/2023
25.1 mL in 1 POUCH; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
NDANDA02152401/01/2020
Labeler - Professional Disposables International, Inc. (800777117)
Establishment
NameAddressID/FEIBusiness Operations
Professional Disposables International, Inc.800777117manufacture(10819-4076)

Revised: 6/2023
Document Id: f5aff4be-ddc9-63ad-e053-2a95a90a426b
Set id: 93ca3c07-40b4-3a91-e053-2995a90a0afd
Version: 4
Effective Time: 20230630
 
Professional Disposables International, Inc.