NDC | 67777-412-01 |
Set ID | b3fe8c85-03cd-44d9-8c28-edb9c05a8115 |
Category | HUMAN OTC DRUG LABEL |
Packager | Dynarex Corporation |
Generic Name | |
Product Class | Amide Local Anesthetic, Antiarrhythmic |
Product Number | |
Application Number | PART348 |
- Active Ingredients
- Purpose
- Uses
- Warnings
- KEEP OUT OF REACH OF CHILDREN
- Stop Use
- Do Not Use
- Directions
- Inactive ingredients
- Other Information
- Principal Display Panel
-
INGREDIENTS AND APPEARANCE
DYNAREX BURN CREAM
lidocaine creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:67777-412 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength LIDOCAINE HYDROCHLORIDE (UNII: V13007Z41A) (LIDOCAINE - UNII:98PI200987) LIDOCAINE HYDROCHLORIDE ANHYDROUS 0.5 g in 100 g BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE 0.13 g in 100 g Inactive Ingredients Ingredient Name Strength ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS) METHYLCELLULOSE (25 MPA.S) (UNII: BI55GG2WLI) CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S) GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4) DIMETHICONE (UNII: 92RU3N3Y1O) CETETH-20 (UNII: I835H2IHHX) BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K) METHYLPARABEN SODIUM (UNII: CR6K9C2NHK) PROPYLPARABEN SODIUM (UNII: 625NNB0G9N) GLYCERIN (UNII: PDC6A3C0OX) EDETATE SODIUM (UNII: MP1J8420LU) WATER (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:67777-412-01 0.9 g in 1 PACKET; Type 0: Not a Combination Product 09/16/2015 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part348 09/01/2015 Labeler - Dynarex Corporation (008124539) Registrant - Dynarex Corporation (008124539) Establishment Name Address ID/FEI Business Operations Galentic Pharma (India) Pvt. Ltd. 650970176 manufacture(67777-412)