Label: PREVANTICS SWAB- chlorhexidine gluconate and isopropyl alcohol solution
- NDC Code(s): 10819-1080-2
- Packager: Professional Disposables International, Inc.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: New Drug Application
Updated October 13, 2023
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- Active ingredients
- For external use only
- Flammable, keep away from fire or flame
- Do not use with electrocautery procedures
This product may cause a severe allergic reaction. Symptoms may inlcude:
- wheezing/difficulty breathing
- facial swelling
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 ingredients 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.
- 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
- Inactive ingredients
- Package/Label Principal Display Panel
INGREDIENTS AND APPEARANCE
chlorhexidine gluconate and isopropyl alcohol solution
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:10819-1080 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:10819-1080-2 3000 in 1 CASE 01/15/2013 1 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 01/15/2013 Labeler - Professional Disposables International, Inc. (800777117) Establishment Name Address ID/FEI Business Operations Professional Disposables International, Inc. 800777117 manufacture(10819-1080)