NDC | 51395-412-01 |
Set ID | 2f9f0d6d-2039-4c21-9d04-02757438be0a |
Category | HUMAN OTC DRUG LABEL |
Packager | Top Safety Products Company Inc |
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
TOP SAFETY FIRST AID BURN CREAM
lidocaine creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:51395-412 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:51395-412-01 2000 in 1 BOX 02/16/2016 1 0.9 g in 1 PACKET; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part348 02/07/2016 Labeler - Top Safety Products Company Inc (627999956)