Label: YOUKE AN- benzalkonium chloride disinfectant spray liquid
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Contains inactivated NDC Code(s)
NDC Code(s): 54749-001-01 - Packager: HUNAN ZONWE PHARMACEUTICAL CO., LTD.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: unapproved drug other
DISCLAIMER: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.
Drug Label Information
Updated November 20, 2020
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- ACTIVE INGREDIENT
- KEEP OUT OF REACH OF CHILDREN
- PURPOSE
- DOSAGE & ADMINISTRATION
- INDICATIONS & USAGE
- INACTIVE INGREDIENT
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WARNINGS
1.This product is one kind of solution for external use, and is never for internal usage.
2.Activity of this product may be affected by anion surfactant or soap, and cannot be used together.
3.It is forbidden for people who are allergic to this product.
4.Turbidity or deposits may appear at a low temperature. It can be placed in warm waterfor heating, or used after it is dissolved through shaking.
5.It shall be sealed and kept in a dark and dry place.
6.Mucosa disinfection is only used for diagnosis and treatment by a medical institution. - PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
YOUKE AN
benzalkonium chloride disinfectant spray liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:54749-001 Route of Administration EXTRACORPOREAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength BENZALKONIUM (UNII: 7N6JUD5X6Y) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM 0.072 mg in 60 mL Inactive Ingredients Ingredient Name Strength PROPYLENE GLYCOL (UNII: 6DC9Q167V3) SODIUM PHOSPHATE, MONOBASIC, DIHYDRATE (UNII: 5QWK665956) SODIUM PHOSPHATE DIBASIC DIHYDRATE (UNII: 94255I6E2T) WATER (UNII: 059QF0KO0R) EDETATE DISODIUM (UNII: 7FLD91C86K) Product Characteristics Color white (transparent) Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:54749-001-01 60 mL in 1 BOTTLE; Type 0: Not a Combination Product 04/06/2020 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved drug other 04/06/2020 Labeler - HUNAN ZONWE PHARMACEUTICAL CO., LTD. (547493962) Establishment Name Address ID/FEI Business Operations HUNAN ZONWE PHARMACEUTICAL CO., LTD. 547493962 manufacture(54749-001)
