NDC | 69804-040-01, 69804-040-04, 69804-040-07, 69804-040-08 |
Set ID | 4821f59f-4f9d-155d-e054-00144ff8d46c |
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 NATURALLY HL SUNBURN RELIEF
lidocaine hcl liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:69804-040 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 NUTMEG OIL (UNII: Z1CLM48948) 75 mg in 1000 mg PIPER METHYSTICUM WHOLE (UNII: 3P306S300W) 200 mg in 1000 mg ACHILLEA MILLEFOLIUM OIL (UNII: 97P5D0WG43) 75 mg in 1000 mg WITCH HAZEL (UNII: 101I4J0U34) 510 mg in 1000 mg COPAIBA OIL (UNII: 64VX45Y68N) 100 mg in 1000 mg Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:69804-040-08 14200 mg in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product 02/10/2017 2 NDC:69804-040-07 28500 mg in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product 02/10/2017 3 NDC:69804-040-04 113400 mg in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product 02/10/2017 4 NDC:69804-040-01 56700 mg in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product 02/10/2017 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part348 02/10/2017 Labeler - ridge properties (029478762) Establishment Name Address ID/FEI Business Operations ridge properties 029478762 manufacture(69804-040)