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| NDC | 69804-035-13, 69804-035-14, 69804-035-15, 69804-035-16 |
| Set ID | 47a5f944-3cdc-5825-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 ITCH RELIEF
lidocaine hcl gelProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:69804-035 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 FLAX SEED (UNII: 4110YT348C) 75 mg in 1000 mg ACHILLEA MILLEFOLIUM OIL (UNII: 97P5D0WG43) 75 mg in 1000 mg WITCH HAZEL (UNII: 101I4J0U34) 200 mg in 1000 mg NUTMEG OIL (UNII: Z1CLM48948) 75 mg in 1000 mg PIPER METHYSTICUM WHOLE (UNII: 3P306S300W) 150 mg in 1000 mg ALOE VERA WHOLE (UNII: KIZ4X2EHYX) 310 mg in 1000 mg COPAIBA OIL (UNII: 64VX45Y68N) 75 mg in 1000 mg Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:69804-035-13 14200 mg in 1 BOTTLE, DISPENSING; Type 0: Not a Combination Product 02/03/2017 2 NDC:69804-035-14 28500 mg in 1 BOTTLE, DISPENSING; Type 0: Not a Combination Product 02/03/2017 3 NDC:69804-035-15 56700 mg in 1 BOTTLE, DISPENSING; Type 0: Not a Combination Product 02/03/2017 4 NDC:69804-035-16 113400 mg in 1 BOTTLE, DISPENSING; Type 0: Not a Combination Product 02/03/2017 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part348 02/03/2017 Labeler - ridge properties (029478762) Establishment Name Address ID/FEI Business Operations ridge properties 029478762 manufacture(69804-035)
