NDC | 55319-959-01 |
Set ID | 75502ecb-15ae-15aa-e053-2991aa0a5acb |
Category | HUMAN OTC DRUG LABEL |
Packager | FAMILY DOLLAR |
Generic Name | |
Product Class | Amide Local Anesthetic, Antiarrhythmic |
Product Number | |
Application Number | PART348 |
- ACTIVE INGREDIENT
- PURPOSE
- WARNINGS
- DO NOT USE
-
WHEN USING
When using this product
■ use only as directed. Read and follow all directions and
warnings on this label. ■ do not allow contact with the eyes
■ do not bandage tightly or apply local heat (such as heating
pads) to the area of use
■ discontinue use at least 1 hour before a bath or shower
■ do not use immediately after a bath or shower
■ dispose of used patch in manner that always keeps product
away from children or 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
- PREGNANCY OR BREAST FEEDING
- KEEP OUT OF REACH OF CHILDREN
-
INDICATIONS & USAGE
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 1 patch for up to 12 hours
■ children 12 years or younger: ask a doctor - STORAGE AND HANDLING
- INACTIVE INGREDIENT
- DOSAGE & ADMINISTRATION
- PRINCIPAL DISPLAY PANEL
-
INGREDIENTS AND APPEARANCE
PAIN RELIEF LIDOCAINE
lidocaine patchProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:55319-959 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987) LIDOCAINE 40 mg in 1 g Inactive Ingredients Ingredient Name Strength DIHYDROXYALUMINUM AMINOACETATE ANHYDROUS (UNII: 1K713C615K) GLYCERIN (UNII: PDC6A3C0OX) METHYLPARABEN (UNII: A2I8C7HI9T) POLYSORBATE 80 (UNII: 6OZP39ZG8H) PROPYLPARABEN (UNII: Z8IX2SC1OH) WATER (UNII: 059QF0KO0R) SODIUM POLYACRYLATE (2500000 MW) (UNII: 05I15JNI2J) TARTARIC ACID (UNII: W4888I119H) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) ALCOHOL (UNII: 3K9958V90M) KAOLIN (UNII: 24H4NWX5CO) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:55319-959-01 1 in 1 POUCH 09/07/2018 1 0.04 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 09/07/2018 Labeler - FAMILY DOLLAR (024472631)