Label: LIDOCAINE patch
- NDC Code(s): 81877-514-15
- Packager: FORREAL PHARMACEUTICALS LLC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: unapproved drug other
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Drug Label Information
Updated June 6, 2024
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- ACTIVE INGREDIENT
- PURPOSE
- INDICATIONS & USAGE
- WARNINGS
- DO NOT USE
- WHEN USING
- STOP USE
- PREGNANCY OR BREAST FEEDING
- KEEP OUT OF REACH OF CHILDREN
-
DOSAGE & ADMINISTRATION
Directions
Adults and children 12 years of age and over:
- Clean and dry the affected area
- Open pouch and remove one patch
- Apply 1 patch at a time to affected area; not more than 3 to 4 times daily
- Reseal pouch containing unused patches after each use
- Remove patch from the skin after at most 8-hour application
Children under 12 years of age: Consult a doctor
- Other information:
- INACTIVE INGREDIENT
- PRINCIPAL DISPLAY PANEL
-
INGREDIENTS AND APPEARANCE
LIDOCAINE
lidocaine patchProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:81877-514 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 BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K) CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311) GLYCERIN (UNII: PDC6A3C0OX) SORBITOL (UNII: 506T60A25R) EDETATE DISODIUM (UNII: 7FLD91C86K) ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS) KAOLIN (UNII: 24H4NWX5CO) SILODRATE ANHYDROUS (UNII: 59110L5W24) 2-ETHYLHEXYL ACRYLATE (UNII: HR49R9S6XG) METHYLPARABEN (UNII: A2I8C7HI9T) POLYACRYLIC ACID (250000 MW) (UNII: 9G2MAD7J6W) POLYSORBATE 80 (UNII: 6OZP39ZG8H) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) PROPYLPARABEN (UNII: Z8IX2SC1OH) WATER (UNII: 059QF0KO0R) SODIUM POLYACRYLATE (2500000 MW) (UNII: 05I15JNI2J) SORBITAN SESQUIOLEATE (UNII: 0W8RRI5W5A) TARTARIC ACID (UNII: W4888I119H) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) UREA (UNII: 8W8T17847W) Product Characteristics Color Score Shape RECTANGLE (White Flexible Patch) Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:81877-514-15 3 in 1 BOX 06/27/2022 1 1 g in 1 POUCH; 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 unapproved drug other 06/27/2022 Labeler - FORREAL PHARMACEUTICALS LLC (118029197)