Label: ANTISEPTIC FORMULA FILLED SWAB- lidocaine hydrochloride, benzalkonium chloride liquid
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Contains inactivated NDC Code(s)
NDC Code(s): 65734-270-00, 65734-270-72 - Packager: Swabplus Inc.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not final
DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
Drug Label Information
Updated March 29, 2013
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Active ingredients
- Purpose
- Uses
- Keep out of reach of children
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Directions
- Hold the swan vertically, with the color tip upwards. Hold in the center of the tube with one hand and at the color ring with the other.
- Gently snap the tip with the color ring. Formula inside the tube flows down and fills the opposite tip.
- Apply the product to the affected area.
- Discard swab after use.
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Warnings
- For external use only. Keep out of eyes and ear canal. Non-Sterile. Discontinue use if irritation occurs.
- Do not use. longer than one week unless directed by a doctor.
- Stop use and ask a doctor if you have deep or puncture wounds, or serious burns, redness, irritation, swelling or pain continues or increase, infection occurs.
- Administration
- Other information
- Inactive ingredients
- Patent
- Package and Label
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INGREDIENTS AND APPEARANCE
ANTISEPTIC FORMULA FILLED SWAB
lidocaine hydrochloride, benzalkonium chloride liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:65734-270 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Lidocaine Hydrochloride (UNII: V13007Z41A) (Lidocaine - UNII:98PI200987) LIDOCAINE HYDROCHLORIDE ANHYDROUS 100 mg in 10 mL BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE 11 mg in 10 mL Inactive Ingredients Ingredient Name Strength Water (UNII: 059QF0KO0R) DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4) Methylparaben (UNII: A2I8C7HI9T) Propylparaben (UNII: Z8IX2SC1OH) Propylene Glycol (UNII: 6DC9Q167V3) Product Characteristics Color white (Colorless) Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:65734-270-72 72 in 1 PACKET 1 NDC:65734-270-00 0.15 mL in 1 APPLICATOR Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part348 03/01/2003 Labeler - Swabplus Inc. (876441549) Registrant - Swabplus Inc (876441549) Establishment Name Address ID/FEI Business Operations Swabplus Inc 876441549 manufacture(65734-270) , relabel(65734-270) , repack(65734-270)
