Label: ANTISEPTIC FORMULA FILLED SWAB - lidocaine hydrochloride and benzalkonium chloride liquid
- 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
NOTE: Most over the counter (OTC) are not reviewed and approved by the FDA. However, they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
Updated March 29, 2013
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- Active ingredients
Benzalkonium Chloride 0.11%
Lidocaine Hydrochloride 1.0%Close
Benzalkonium Chloride for Antiseptic
Lidocaine Hydrochloride for Pain reliefClose
Uses First aid to help prevent infection, and temporarily relieve pain and itching associated with minor cuts, scrapes and burns.Close
- Keep out of reach of children
If swallowed, get medical help or contact a Poison Control Center right away.Close
- 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.
- 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.
- For adult and children 2 and older:Clean affected area and apply 1 to 3 times daily. May be covered with a bandage.
- Children under 2 years of age: Do not use, consult a doctor.
- Other information
Store at room temperature.Avoid direct sunlight, excessive heat and moistgure.Close
- Inactive ingredients
Dizolidinyl Urea, Methylparaben, Propylparben, water.Close
Patented and manufactured by Swabplus Inc. Rancho Cucamonga, CA 91730 Made in USA
The COLOR RING is copyrighted by Swabplus Inc. ©2007 SWABPLUS INC.Close
- Package and Label
Image of antiseptic carton label
- INGREDIENTS AND APPEARANCE
ANTISEPTIC FORMULA FILLED SWAB
lidocaine hydrochloride, benzalkonium chloride liquid
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:65734-270 Route of Administration TOPICAL DEA Schedule 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)