Label: SANITAXE ANTIBACTERIAL AMBER HAND 27 FL OZ- benzalkonium chloride liquid
- NDC Code(s): 76176-124-01
- Packager: NINGBO LIYUAN DAILY CHEMICAL PRODUCTS 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 September 1, 2020
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- Drug Facts Active Ingredient
- Purpose
- Uses
- Warnings
- Stop use and ask a doctor
- Keep out of reach of children.
- Directions
- Inactive ingredients:
- Loading Instructions
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
SANITAXE ANTIBACTERIAL AMBER HAND 27 FL OZ
benzalkonium chloride liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:76176-124 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 mL Inactive Ingredients Ingredient Name Strength FD&C RED NO. 40 (UNII: WZB9127XOA) METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA) WATER (UNII: 059QF0KO0R) COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX) IODOPROPYNYL BUTYLCARBAMATE (UNII: 603P14DHEB) SODIUM COCOAMPHOACETATE (UNII: W7Q5E87674) PEG-150 DISTEARATE (UNII: 6F36Q0I0AC) CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) FD&C YELLOW NO. 5 (UNII: I753WB2F1M) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:76176-124-01 800 mL in 1 BAG; Type 0: Not a Combination Product 01/01/2019 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part333A 01/01/2015 Labeler - NINGBO LIYUAN DAILY CHEMICAL PRODUCTS CO., LTD. (530766098) Registrant - NINGBO LIYUAN DAILY CHEMICAL PRODUCTS CO., LTD. (530766098) Establishment Name Address ID/FEI Business Operations NINGBO LIYUAN DAILY CHEMICAL PRODUCTS CO., LTD. 530766098 manufacture(76176-124)