NDC | 69804-045-05, 69804-045-06, 69804-045-15, 69804-045-16 |
Set ID | 4c0d9919-cc42-2508-e054-00144ff88e88 |
Category | HUMAN OTC DRUG LABEL |
Packager | ridge properties |
Generic Name | |
Product Class | Amide Local Anesthetic, Antiarrhythmic |
Product Number | |
Application Number | PART348 |
- DOSAGE & ADMINISTRATION
- WARNINGS
- KEEP OUT OF REACH OF CHILDREN
- PURPOSE
- INDICATIONS & USAGE
- ACTIVE INGREDIENT
- INACTIVE INGREDIENT
- PRINCIPAL DISPLAY PANEL
-
INGREDIENTS AND APPEARANCE
EXTRA STRENGTH PRURITIS CARE
lidocaine hcl creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:69804-045 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 COPAIBA OIL (UNII: 64VX45Y68N) 90 mg in 1000 mg BEHENTRIMONIUM METHOSULFATE (UNII: 5SHP745C61) 120 mg in 1000 mg ACHILLEA MILLEFOLIUM OIL (UNII: 97P5D0WG43) 60 mg in 1000 mg PROPOLIS WAX (UNII: 6Y8XYV2NOF) 40 mg in 1000 mg NUTMEG OIL (UNII: Z1CLM48948) 60 mg in 1000 mg PIPER METHYSTICUM WHOLE (UNII: 3P306S300W) 190 mg in 1000 mg WITCH HAZEL (UNII: 101I4J0U34) 400 mg in 1000 mg Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:69804-045-06 14200 mg in 1 JAR; Type 0: Not a Combination Product 04/03/2017 2 NDC:69804-045-05 28500 mg in 1 JAR; Type 0: Not a Combination Product 04/03/2017 3 NDC:69804-045-15 56700 mg in 1 JAR; Type 0: Not a Combination Product 04/03/2017 4 NDC:69804-045-16 113400 mg in 1 JAR; Type 0: Not a Combination Product 04/03/2017 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part348 04/03/2017 Labeler - ridge properties (029478762) Establishment Name Address ID/FEI Business Operations ridge properties 029478762 manufacture(69804-045)