NDC | 76348-416-02 |
Set ID | 4d0fc18f-1381-5103-e054-00144ff88e88 |
Category | HUMAN OTC DRUG LABEL |
Packager | Renu Laboratories, Inc. |
Generic Name | |
Product Class | Amide Local Anesthetic, Antiarrhythmic |
Product Number | |
Application Number | PART348 |
- DOSAGE & ADMINISTRATION
- ACTIVE INGREDIENT
- STOP USE
- ASK DOCTOR
- DO NOT USE
- INDICATIONS & USAGE
- PURPOSE
- PREGNANCY OR BREAST FEEDING
- WARNINGS
- INACTIVE INGREDIENT
- KEEP OUT OF REACH OF CHILDREN
- PRINCIPAL DISPLAY PANEL
-
INGREDIENTS AND APPEARANCE
TLC PLUS ANESTHETIC G
lidocaine gel gelProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:76348-416 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength LIDOCAINE HYDROCHLORIDE (UNII: V13007Z41A) (LIDOCAINE - UNII:98PI200987) LIDOCAINE HYDROCHLORIDE ANHYDROUS 2.36 g in 59 g Inactive Ingredients Ingredient Name Strength ALCOHOL (UNII: 3K9958V90M) WATER (UNII: 059QF0KO0R) GLYCERIN (UNII: PDC6A3C0OX) ALOE (UNII: V5VD430YW9) EDETATE DISODIUM (UNII: 7FLD91C86K) BENZYL ALCOHOL (UNII: LKG8494WBH) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:76348-416-02 59 g in 1 JAR; Type 0: Not a Combination Product 07/28/2017 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part348 07/28/2017 Labeler - Renu Laboratories, Inc. (945739449) Establishment Name Address ID/FEI Business Operations Renu Laboratories, Inc. 945739449 manufacture(76348-416)