Label: REFILL 2- benzalkonium chloride, bacitracin zinc, neomycin sulfate, polymyxin b sulfate kit
- NDC Code(s): 49687-0011-1, 49687-0013-0, 49687-0016-0
- Packager: CMC Group, Inc.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated December 21, 2023
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- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Drug Facts - Antiseptic Towelettes
- Active Ingredient:
- Use:
- Warnings:
- Directions:
- Inactive ingredient:
- Drug Facts - Antibiotic Application
- Active ingredients (in each gram)
- Use
- Warnings
- Directions
- Inactive ingredients
- Antiseptic Towelettes (49687-0016-0) Labeling:
- Antibiotic Application (49687-0013-0) Labeling:
- Refill 2 (49687-0016-0) Labeling:
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INGREDIENTS AND APPEARANCE
REFILL 2
benzalkonium chloride, bacitracin zinc, neomycin sulfate, polymyxin b sulfate kitProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:49687-0016 Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:49687-0016-0 1 in 1 KIT 08/10/2016 Quantity of Parts Part # Package Quantity Total Product Quantity Part 1 20 PATCH 18 g Part 2 10 PACKAGE 9 g Part 1 of 2 ANTISEPTIC TOWELETTES
benzalkonium chloride clothProduct Information Item Code (Source) NDC:49687-0011 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 2 in 1 BOX 1 NDC:49687-0011-1 10 in 1 BOX 1 0.9 g in 1 PATCH; Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.) Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M003 08/10/2016 Part 2 of 2 ANTIBIOTIC APPLICATION
bacitracin zinc, neomycin sulfate, polymyxin b sulfate ointmentProduct Information Item Code (Source) NDC:49687-0013 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength BACITRACIN ZINC (UNII: 89Y4M234ES) (BACITRACIN - UNII:58H6RWO52I) BACITRACIN 400 [iU] in 1 g NEOMYCIN SULFATE (UNII: 057Y626693) (NEOMYCIN - UNII:I16QD7X297) NEOMYCIN 3.5 mg in 1 g POLYMYXIN B SULFATE (UNII: 19371312D4) (POLYMYXIN B - UNII:J2VZ07J96K) POLYMYXIN B 5000 [iU] in 1 g Inactive Ingredients Ingredient Name Strength MINERAL OIL (UNII: T5L8T28FGP) PETROLATUM (UNII: 4T6H12BN9U) WATER (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:49687-0013-0 10 in 1 KIT 1 0.9 g in 1 PACKAGE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M004 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug part333 08/10/2016 Labeler - CMC Group, Inc. (117201448)