NDC | 52564-330-17 |
Set ID | a15fedd5-8a55-43ef-a2d9-0b4e338b1d44 |
Category | HUMAN OTC DRUG LABEL |
Packager | Mueller Sports Medicine, Inc. |
Generic Name | |
Product Class | Amide Local Anesthetic, Antiarrhythmic |
Product Number | |
Application Number | PART348 |
- ACTIVE INGREDIENT
- DOSAGE & ADMINISTRATION
- WARNINGS
- INACTIVE INGREDIENT
- INDICATIONS & USAGE
- KEEP OUT OF REACH OF CHILDREN
- PURPOSE
- PRINCIPAL DISPLAY PANEL
-
INGREDIENTS AND APPEARANCE
MUELLER FIRST AID ANTISEPTIC
benzalkonium chloride, lidocaine hydrochloride sprayProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:52564-330 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength LIDOCAINE HYDROCHLORIDE (UNII: V13007Z41A) (LIDOCAINE - UNII:98PI200987) LIDOCAINE 2 g in 100 mL BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE 0.13 g in 100 mL Inactive Ingredients Ingredient Name Strength TEA TREE OIL (UNII: VIF565UC2G) TROLAMINE (UNII: 9O3K93S3TK) WATER (UNII: 059QF0KO0R) HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO) OCTOXYNOL-9 (UNII: 7JPC6Y25QS) METHYLPARABEN (UNII: A2I8C7HI9T) DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4) EDETATE DISODIUM (UNII: 7FLD91C86K) GLYCERIN (UNII: PDC6A3C0OX) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) PROPYLPARABEN (UNII: Z8IX2SC1OH) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:52564-330-17 59 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product 08/16/2013 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part348 08/16/2013 Labeler - Mueller Sports Medicine, Inc. (006426316)