NDC | 69804-071-01, 69804-071-04, 69804-071-07 |
Set ID | 5de53e2c-a091-2182-e053-2991aa0af9c6 |
Category | HUMAN OTC DRUG LABEL |
Packager | ridge properties llc |
Generic Name | |
Product Class | Amide Local Anesthetic, Antiarrhythmic |
Product Number | |
Application Number | PART348 |
- DOSAGE & ADMINISTRATION
- INACTIVE INGREDIENT
- INDICATIONS & USAGE
- KEEP OUT OF REACH OF CHILDREN
- ACTIVE INGREDIENT
- PURPOSE
- WARNINGS
- PRINCIPAL DISPLAY PANEL
-
INGREDIENTS AND APPEARANCE
SUPERIOR PAIN AND ITCH RELIEF
lidocaine hcl liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:69804-071 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 BENZYL ALCOHOL (UNII: LKG8494WBH) 10 mg in 1000 mg PIPER METHYSTICUM ROOT (UNII: BOW48C81XP) 11 mg in 1000 mg PROPYLENE GLYCOL (UNII: 6DC9Q167V3) 689 mg in 1000 mg CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO) 1 mg in 1000 mg WATER (UNII: 059QF0KO0R) 69 mg in 1000 mg COPAIBA OIL (UNII: 64VX45Y68N) 180 mg in 1000 mg Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:69804-071-07 28500 mg in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product 11/27/2017 2 NDC:69804-071-01 56700 mg in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product 11/27/2017 3 NDC:69804-071-04 113400 mg in 1 BOTTLE, SPRAY; 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 Labeler - ridge properties llc (029478762) Establishment Name Address ID/FEI Business Operations ridge properties llc 029478762 manufacture(69804-071)