NDC | 46122-450-21 |
Set ID | 614f1e56-891f-4620-be10-0c075a1dbc3f |
Category | HUMAN OTC DRUG LABEL |
Packager | Amerisource Bergen |
Generic Name | |
Product Class | Amide Local Anesthetic, Antiarrhythmic |
Product Number | |
Application Number | PART348 |
- Active Ingredients
- Purpose
-
Dosage and Administration
Directions Adults and children over 12 years:
■ clean and dry affected area
■ remove backing from patch by firmly grasping both ends and gently pulling until backing separates in middle
■ carefully remove smaller portion of backing from patch starting at corner
■ apply sticky side of patch to affected area
■ use one patch for up to 12 hours. Children under 12 years of age: consult a physician.
- Warnings
- Idications and Usage
-
When using this product
■ use only as directed
■ read and follow all directions and warnings on this carton
■ do not allow contact with the eyes
■ do not use at the same time as other topical analgesics
■ do not bandage tightly or apply local heat (such as heating pads) to the area of use
■ do not microwave
■ dispose of used patch in manner that always keeps product away from children and pets. Used patches still contain the drug product that can produce serious adverse effects if a child or pet chews or ingests this patch.
- Stop use and consult a doctor
- PREGNANCY OR BREAST FEEDING
- Do not Use
- Keep out of reach of children and pets.
- Other Safety Information
- Inactive Ingredients
- Questions
- PRINCIPAL DISPLAY PANEL
-
INGREDIENTS AND APPEARANCE
PAIN RELIEF PATCHES
lidocaine patchProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:46122-450 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987) LIDOCAINE 4 g in 100 g Inactive Ingredients Ingredient Name Strength Aluminum (UNII: CPD4NFA903) Glycerin (UNII: PDC6A3C0OX) Kaolin (UNII: 24H4NWX5CO) Methylparaben (UNII: A2I8C7HI9T) POLYACRYLIC ACID (300000 MW) (UNII: A8371R0U5J) POLYSORBATE 80 (UNII: 6OZP39ZG8H) Propylene Glycol (UNII: 6DC9Q167V3) Propylparaben (UNII: Z8IX2SC1OH) PVP/VA COPOLYMER (UNII: D9C330MD8B) SODIUM POLYACRYLATE (2500000 MW) (UNII: 05I15JNI2J) TARTARIC ACID (UNII: W4888I119H) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) WATER (UNII: 059QF0KO0R) Product Characteristics Color Score Shape RECTANGLE Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:46122-450-21 5 in 1 CARTON 07/01/2017 1 9 g in 1 PATCH; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part348 07/01/2017 Labeler - Amerisource Bergen (007914906) Establishment Name Address ID/FEI Business Operations Foshan Aqua Gel Biotech Co.,Ltd. 529128763 manufacture(46122-450)