Label: LORIS BZK ANTISEPTIC WIPES- benzalkonium chloride swab
- NDC Code(s): 68356-126-01, 68356-126-02, 68356-126-03, 68356-126-04
- Packager: LernaPharm Loris 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.
Updated May 9, 2013
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- Active Ingredients
Benzalkonium chloride, 0.13% v/vClose
First Aid AntisepticClose
First aid to help reduce the risk of infection in minor cuts, scrapes, and burns.Close
For External Use Only
- Do not use in the eyes or apply over large areas of the body.
- In case of deep or puncture wounds, animal bites, or serious burns, consult a doctor.
- Stop use and consult a doctor if the condition persists or gets worse.
- Do not use for longer than 1 week unless directed by a doctor.
Keep out of reach of children. If swallowed get medical help or contact a Poison Control Center right away.
- Tear open pouch and use as part of your daily cleansing routine.
- Clean the affected area.
- Apply this product on the area 1 to 3 times daily.
- May be covered with a sterile bandage.
- If bandaged, let dry first.
- Other Information
Store at room temperature between 59-86oF (15-30oC). If contact with eyes occurs, flush eyes with water.Close
- Inactive Ingredients
- Questions or comments?
Call 1-866-322-4634, weekdays between 8:00 am and 6:00 pm ESTClose
- PRINCIPAL DISPLAY PANEL
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- INGREDIENTS AND APPEARANCE
LORIS BZK ANTISEPTIC WIPES
benzalkonium chloride swab
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:68356-126 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE 0.13 g in 100 g Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:68356-126-01 100 in 1 BOX 1 NDC:68356-126-02 2.6 g in 1 PACKET 2 NDC:68356-126-04 2.6 g in 1 PACKET 3 NDC:68356-126-03 3 in 1 PACKAGE 3 2.5 g in 1 APPLICATOR Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part333A 11/21/2012 Labeler - LernaPharm Loris Inc. (206940905) Establishment Name Address ID/FEI Business Operations LernaPharm Loris Inc. 206940905 manufacture(68356-126) , label(68356-126)