NDC | 69329-040-30 |
Set ID | 13cfbd7c-759b-73ca-e054-00144ff8d46c |
Category | HUMAN OTC DRUG LABEL |
Packager | Patchwerx Labs, Inc. |
Generic Name | |
Product Class | Amide Local Anesthetic, Antiarrhythmic |
Product Number | |
Application Number | PART348 |
- Active Ingredient Section
- ASK DOCTOR SECTION
- DO NOT USE SECTION
- KEEP OUT OF REACH OF CHILDREN
- PREGNANCY OR BREAST FEEDING
- PURPOSE
- QUESTIONS
- STOP USE SECTION
- WHEN USING SECTION
- Package Label
- Dosage and Administration These highlights do not include all the information needed to use
- Warnings
- Inactive Ingredients These highlights do not include all the information needed to use
- Indications and usage
-
INGREDIENTS AND APPEARANCE
SCADEXE
allantoin, lidocaine, petrolatum patchProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:69329-040 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength LIDOCAINE HYDROCHLORIDE (UNII: V13007Z41A) (LIDOCAINE - UNII:98PI200987) LIDOCAINE HYDROCHLORIDE 4 g in 100 g PETROLATUM (UNII: 4T6H12BN9U) (PETROLATUM - UNII:4T6H12BN9U) PETROLATUM 30 g in 100 g ALLANTOIN (UNII: 344S277G0Z) (ALLANTOIN - UNII:344S277G0Z) ALLANTOIN 2 g in 100 g Inactive Ingredients Ingredient Name Strength ONION (UNII: 492225Q21H) ALPHA-TOCOPHEROL (UNII: H4N855PNZ1) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:69329-040-30 30 in 1 BOX 1 10 g in 1 PATCH; Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.) Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part348 04/15/2015 Labeler - Patchwerx Labs, Inc. (079584480)