Label: BANDAGE- benzalkonium chloride swab
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Contains inactivated NDC Code(s)
NDC Code(s): 59194-001-01, 59194-001-02, 59194-001-03, 59194-001-04, view more59194-001-05, 59194-001-06, 59194-001-07, 59194-001-08, 59194-001-09 - Packager: Zhejiang Changdi Medical Co., Ltd.
- 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 August 5, 2013
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- Active Ingredients
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- Inactive Ingredient
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
BANDAGE
benzalkonium chloride swabProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:59194-001 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE 0.0012 mg in 1 mg Inactive Ingredients Ingredient Name Strength COTTON FIBER (UNII: 70LDW53ROO) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:59194-001-01 24 in 1 CARTON 1 40 in 1 BOX 1 0.0459 mg in 1 POUCH 2 NDC:59194-001-02 18 in 1 CARTON 2 25 in 1 BOX 2 0.0459 mg in 1 POUCH 3 NDC:59194-001-03 18 in 1 CARTON 3 20 in 1 BOX 3 0.0459 mg in 1 POUCH 4 NDC:59194-001-04 18 in 1 CARTON 4 15 in 1 BOX 4 0.0459 mg in 1 POUCH 5 NDC:59194-001-05 24 in 1 CARTON 5 40 in 1 BOX 5 0.0459 mg in 1 POUCH 6 NDC:59194-001-06 24 in 1 CARTON 6 20 in 1 BOX 6 0.0459 mg in 1 POUCH 7 NDC:59194-001-07 24 in 1 CARTON 7 15 in 1 BOX 7 0.0459 mg in 1 POUCH 8 NDC:59194-001-08 24 in 1 CARTON 8 20 in 1 BOX 8 0.0459 mg in 1 POUCH 9 NDC:59194-001-09 24 in 1 CARTON 9 25 in 1 BOX 9 0.0459 mg in 1 POUCH Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part333A 05/20/2013 Labeler - Zhejiang Changdi Medical Co., Ltd. (528198683) Establishment Name Address ID/FEI Business Operations Zhejiang Changdi Medical Co., Ltd. 528198683 manufacture(59194-001)
