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

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S40750- NDC 10819-4077-1
S40750- NDC 10819-4077-4
S32450- NDC 10819-4077-2
S42850- NDC 10819-4077-3

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

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

Packet Label

packet label

Box Label

Box label

Packet (bulk)

bulk label

bulk label 2

Insert

insert

insert 2

PREVANTICS SWABSTICK 
chlorhexidine gluconate and isopropyl alcohol solution
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:10819-4077
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:10819-4077-450 in 1 BOX06/01/2020
1NDC:10819-4077-11.6 mL in 1 POUCH; Type 0: Not a Combination Product
2NDC:10819-4077-2500 in 1 CASE06/01/2020
21.6 mL in 1 POUCH; Type 0: Not a Combination Product
3NDC:10819-4077-3500 in 1 CASE06/01/2020
31.6 mL in 1 POUCH; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
NDANDA02152406/01/2020
Labeler - Professional Disposables International, Inc. (800777117)
Establishment
NameAddressID/FEIBusiness Operations
Professional Disposables International, Inc.800777117manufacture(10819-4077)

Revised: 3/2021
Document Id: bd3387ac-3695-1fb0-e053-2a95a90a161f
Set id: 9841200b-d4c6-b40c-e053-2995a90a5596
Version: 2
Effective Time: 20210310
 
Professional Disposables International, Inc.