Label: ANTIBACTERIAL AQUA CLEAR 2X ULTRA- benzalkonium chloride liquid
- NDC Code(s): 71020-030-30, 71020-030-64
- Packager: Sante Manufacturing Inc
- Category: HUMAN OTC DRUG LABEL
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 January 17, 2022
If you are a healthcare professional or from the pharmaceutical industry please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- ACTIVE INGREDIENT
- PURPOSE
- DOSAGE & ADMINISTRATION
- WARNINGS
- STOP USE
- WHEN USING
- KEEP OUT OF REACH OF CHILDREN
- INACTIVE INGREDIENT
- INDICATIONS & USAGE
- PRINCIPAL DISPLAY PANEL
-
INGREDIENTS AND APPEARANCE
ANTIBACTERIAL AQUA CLEAR 2X ULTRA
benzalkonium chloride liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:71020-030 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 mg in 1 mL Inactive Ingredients Ingredient Name Strength CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) WATER (UNII: 059QF0KO0R) SODIUM LAURETH SULFATE (UNII: BPV390UAP0) COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX) SODIUM CHLORIDE (UNII: 451W47IQ8X) GLYCERIN (UNII: PDC6A3C0OX) DITETRACYCLINE TETRASODIUM EDETATE (UNII: WX0A0IT7K5) METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN) METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA) FD&C BLUE NO. 1 (UNII: H3R47K3TBD) FD&C RED NO. 4 (UNII: X3W0AM1JLX) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:71020-030-64 1900 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 10/08/2016 2 NDC:71020-030-30 600 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 10/08/2016 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part333A 10/08/2016 Labeler - Sante Manufacturing Inc (242048747) Registrant - Sante Manufacturing Inc (242048747) Establishment Name Address ID/FEI Business Operations Sante Manufacturing Inc 204348627 manufacture(71020-030) Establishment Name Address ID/FEI Business Operations Brands International Corporation 243748238 manufacture(71020-030)