Label: PAIN RELIEF LIDOCAINE- lidocaine patch
- NDC Code(s): 55319-959-01
- Packager: FAMILY DOLLAR
- Category: HUMAN OTC DRUG LABEL
DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
Drug Label Information
Updated March 31, 2022
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- 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)