Label: AQUABAIN ANTIBACTERIAL RED FRUITS- benzalkonium chloride 0.13% liquid
- NDC Code(s): 62476-004-16
- Packager: Industria La Popular, S.A.
- 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 December 14, 2021
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- Official Label (Printer Friendly)
- Active Ingredient
- Purpose
- Uses
- Warnings
- When using this product
- Stop use
- Keep out of reach of children.
- Directions
- Other Information
- Inactive Ingredients
- Aquabain Antibacterial Hand Soap Red Fruits
-
INGREDIENTS AND APPEARANCE
AQUABAIN ANTIBACTERIAL RED FRUITS
benzalkonium chloride 0.13% liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:62476-004 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE 0.65 g in 500 mL Inactive Ingredients Ingredient Name Strength COCAMIDE (UNII: 3YXD33R71G) METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN) SODIUM LAURYL SULFATE (UNII: 368GB5141J) WATER (UNII: 059QF0KO0R) GLYCERIN (UNII: PDC6A3C0OX) METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA) ANHYDROUS CITRIC ACID (UNII: XF417D3PSL) SODIUM CHLORIDE (UNII: 451W47IQ8X) FD&C YELLOW NO. 5 (UNII: I753WB2F1M) FD&C RED NO. 40 (UNII: WZB9127XOA) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:62476-004-16 500 mL in 1 BOTTLE; Type 0: Not a Combination Product 08/01/2020 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part333A 08/01/2020 Labeler - Industria La Popular, S.A. (846044576)