Label: ANTISEPTIC- benzalkonium chloride liquid
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Contains inactivated NDC Code(s)
NDC Code(s): 61010-7110-0, 61010-7110-1 - Packager: Safetec of America
- 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 July 12, 2011
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- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- SPL UNCLASSIFIED SECTION
- Active Ingredients
- Purpose
- Uses
- Warnings
- Directions
- Inactive ingredients
- PRINCIPAL DISPLAY PANEL – pouch label
- PRINCIPAL DISPLAY PANEL – box label
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INGREDIENTS AND APPEARANCE
ANTISEPTIC
benzalkonium chloride liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:61010-7110 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength benzalkonium chloride (UNII: F5UM2KM3W7) (benzalkonium - UNII:7N6JUD5X6Y) benzalkonium chloride 1.30 mL in 1 L Inactive Ingredients Ingredient Name Strength water (UNII: 059QF0KO0R) alcohol (UNII: 3K9958V90M) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:61010-7110-1 100 in 1 BOX 1 NDC:61010-7110-0 0.0025 L in 1 POUCH Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part333E 07/12/2011 Labeler - Safetec of America (874965262) Establishment Name Address ID/FEI Business Operations Safetec of America, Inc. 874965262 MANUFACTURE