SORE RELIEF
lidocaine hcl gel |
| Product Information |
| Product Type | HUMAN OTC DRUG | Item Code (Source) | NDC: 69804-077 |
| Route of Administration | TOPICAL |
|
| Active Ingredient/Active Moiety |
| Ingredient Name | Basis of Strength | Strength |
| LIDOCAINE HYDROCHLORIDE (UNII: V13007Z41A) (LIDOCAINE - UNII:98PI200987) | LIDOCAINE HYDROCHLORIDE ANHYDROUS | 40 mg in 1000 mg |
|
| Inactive Ingredients |
| Ingredient Name | Strength |
| BANANA (UNII: 4AJZ4765R9) | 22 mg in 1000 mg |
| CASHEW OIL (UNII: PI97M87E46) | 22 mg in 1000 mg |
| PIPER METHYSTICUM WHOLE (UNII: 3P306S300W) | 307 mg in 1000 mg |
| NUTMEG OIL (UNII: Z1CLM48948) | 133 mg in 1000 mg |
| BORIC ACID (H3BO3), COMPD. WITH 2,2',2''-NITRILOTRIS(ETHANOL) (1:3) (UNII: 43O5OP619T) | 45 mg in 1000 mg |
| MARANTA ARUNDINACEA ROOT (UNII: FVN346W31A) | 98 mg in 1000 mg |
| CARBOMER 940 (UNII: 4Q93RCW27E) | 13 mg in 1000 mg |
| WITCH HAZEL (UNII: 101I4J0U34) | 89 mg in 1000 mg |
| COPAIBA OIL (UNII: 64VX45Y68N) | 89 mg in 1000 mg |
| BENTONITE (UNII: A3N5ZCN45C) | 9 mg in 1000 mg |
| ACHILLEA MILLEFOLIUM OIL (UNII: 97P5D0WG43) | 133 mg in 1000 mg |
|
|
| Packaging |
| # | Item Code | Package Description | Marketing Start Date | Marketing End Date |
| 1 | NDC: 69804-077-14 | 28500 mg in 1 BOTTLE, DISPENSING; Type 0: Not a Combination Product | 11/27/2017 | |
| 2 | NDC: 69804-077-15 | 56700 mg in 1 BOTTLE, DISPENSING; Type 0: Not a Combination Product | 11/27/2017 | |
| 3 | NDC: 69804-077-16 | 113400 mg in 1 BOTTLE, DISPENSING; Type 0: Not a Combination Product | 11/27/2017 | |
|
|
| Marketing Information |
| Marketing Category | Application Number or Monograph Citation | Marketing Start Date | Marketing End Date |
| OTC monograph not final | part348 | 11/27/2017 | |
|