NDC | 69538-100-01, 69538-100-02, 69538-100-03, 69538-100-04 |
Set ID | 9d177958-2b50-4a3e-b7b8-27b86eab88ef |
Category | HUMAN OTC DRUG LABEL |
Packager | CANADIA USA CORPORATION |
Generic Name | |
Product Class | |
Product Number | |
Application Number | PART333A |
- Active ingredient
- Purpose
- Uses
- Warnings:
- Directions:
- SPL UNCLASSIFIED SECTION
- Inactive ingredients:
- Principal Display Panel
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INGREDIENTS AND APPEARANCE
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benzalkonium chloride swabProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:69538-100 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) ALOE VERA LEAF (UNII: ZY81Z83H0X) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) POLIHEXANIDE (UNII: 322U039GMF) HYDROGENATED CASTOR OIL (UNII: ZF94AP8MEY) SODIUM CITRATE (UNII: 1Q73Q2JULR) EDETATE DISODIUM (UNII: 7FLD91C86K) CETYLPYRIDINIUM (UNII: CUB7JI0JV3) PHENOXYETHANOL (UNII: HIE492ZZ3T) GLYCINE (UNII: TE7660XO1C) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:69538-100-01 36 in 1 BOX 1 8 in 1 PACKAGE 1 3 g in 1 PACKET; Type 0: Not a Combination Product 2 NDC:69538-100-02 4 in 1 BOX 2 10 in 1 CARTON 2 8 in 1 PACKAGE 2 3 g in 1 PACKET; Type 0: Not a Combination Product 3 NDC:69538-100-03 8 in 1 BOX 3 10 in 1 CARTON 3 8 in 1 PACKAGE 3 3 g in 1 PACKET; Type 0: Not a Combination Product 4 NDC:69538-100-04 12 in 1 BOX 4 10 in 1 CARTON 4 8 in 1 PACKAGE 4 3 g in 1 PACKET; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part333A 08/21/2015 Labeler - CANADIA USA CORPORATION (012119600) Establishment Name Address ID/FEI Business Operations Nox-Bellcow (Zhongshan) Nonwo ven Chemical Ltd 528103343 manufacture(69538-100)