Label: PREVANTICS SWABSTICK- chlorhexidine gluconate and isopropyl alcohol solution
- NDC Code(s): 10819-4077-1, 10819-4077-2, 10819-4077-3, 10819-4077-4
- Packager: Professional Disposables International, Inc.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: New Drug Application
Drug Label Information
Updated March 10, 2021
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Active ingredients
- Purposes
- Use
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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.
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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: 4 by 4 inches (10 by 10 cm) or moist site: 3 by 5 inches (7.5 by 12.5 cm)
- tear open the pouch to expose the swabstick
- remove the 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) half 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
- Inactive ingredients
- Package/Label Principal Display Panel
-
INGREDIENTS AND APPEARANCE
PREVANTICS SWABSTICK
chlorhexidine gluconate and isopropyl alcohol solutionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:10819-4077 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:10819-4077-4 50 in 1 BOX 06/01/2020 1 NDC:10819-4077-1 1.6 mL in 1 POUCH; Type 0: Not a Combination Product 2 NDC:10819-4077-2 500 in 1 CASE 06/01/2020 2 1.6 mL in 1 POUCH; Type 0: Not a Combination Product 3 NDC:10819-4077-3 500 in 1 CASE 06/01/2020 3 1.6 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 06/01/2020 Labeler - Professional Disposables International, Inc. (800777117) Establishment Name Address ID/FEI Business Operations Professional Disposables International, Inc. 800777117 manufacture(10819-4077)
