Label: ANTIBACTERIAL- benzalkonium chloride 0.13% liquid
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Contains inactivated NDC Code(s)
NDC Code(s): 76772-006-80 - Packager: TSM ITHALAT IHRACAT SANAYI VE DIS TICARET LIMITED SIRKETI
- 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 May 1, 2020
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- Active ingredients
- Purpose
- Use
- Warnings
- When using this product
- Stop use and ask a doctor if
- Keep out of reach of children
- Directions
- inactive ingredientsc
- Adverse Reactions
- principal display panel
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INGREDIENTS AND APPEARANCE
ANTIBACTERIAL
benzalkonium chloride 0.13% liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:76772-006 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE 1.3 g in 1 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) SODIUM LAURETH SULFATE (UNII: BPV390UAP0) COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX) POLYQUATERNIUM-10 (1000 MPA.S AT 2%) (UNII: GMR4PEN8PK) SODIUM CHLORIDE (UNII: 451W47IQ8X) METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA) GLYCERIN (UNII: PDC6A3C0OX) COCAMIDOPROPYL PG-DIMONIUM CHLORIDE (UNII: 205Z54J075) METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN) CITRIC ACID ACETATE (UNII: DSO12WL7AU) EDETIC ACID (UNII: 9G34HU7RV0) FD&C BLUE NO. 1 (UNII: H3R47K3TBD) D&C RED NO. 33 (UNII: 9DBA0SBB0L) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:76772-006-80 500 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product 04/15/2015 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part333A 04/15/2015 Labeler - TSM ITHALAT IHRACAT SANAYI VE DIS TICARET LIMITED SIRKETI (533120570)