NDC | 0536-1202-15 |
Set ID | b34e40c8-a257-46cf-9399-f55df9b4102d |
Category | HUMAN OTC DRUG LABEL |
Packager | RUGBY LABORATORIES |
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 and apply exposed portion of patch to affected area
■ once exposed portion of patch is positioned, carefully remove remaining backing to completely apply patch to affected area
■ use one patch for up to 12 hours. Children under 12 years of age: consult a physician.
- Warnings
- Indications 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
- Active Ingredient
- Purpose
-
Warnings
For external use only.
Do not use
■ more than one patch on your body at a time
■ on cut, irritated or swollen skin
■ on puncture wounds
■ for more than one week without consulting a doctor
■ if you are allergic to any active or inactive ingredients
■ if pouch is damaged or opened.
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.
-
Directions
Directions Adults and children 12 years of age and over:
■ clean and dry affected area
■ carefully remove backing from patch starting at a corner
■ apply sticky side of patch to affected area
■ use one patch for up to 12 hours.
- Discard patch after single use
- Children under 12 years of age: consult a physician.
- Other safety information
- Inactive Ingredients
- PRINCIPAL DISPLAY PANEL
- Lidocaine Pain Relief Patch 30ct
-
INGREDIENTS AND APPEARANCE
RUGBY PAIN RELIEF PATCHES
lidocaine patchProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:0536-1202 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) POVIDONE, UNSPECIFIED (UNII: FZ989GH94E) 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:0536-1202-15 5 in 1 CARTON 04/01/2019 1 9 g in 1 PATCH; Type 0: Not a Combination Product 2 NDC:0536-1202-07 30 in 1 CARTON 05/01/2021 2 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 04/01/2019 Labeler - RUGBY LABORATORIES (079246066) Establishment Name Address ID/FEI Business Operations Foshan Aqua Gel Biotech Co.,Ltd. 529128763 manufacture(0536-1202)