Label: LIDOCAINE patch
- NDC Code(s): 79643-005-01
- Packager: PHARMACURE LLC
- Category: HUMAN OTC DRUG LABEL
Drug Label Information
Updated December 16, 2024
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- Official Label (Printer Friendly)
- Active Ingredient
- Purpose
- Uses
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Warnings
Do not use on the face or rashes, on wounds or damaged skin, in the eyes, mouth, or other mucous membranes, on genitals, with a heating pad, any patch from a pouch that has been opened for 7 or more days.
Ask a doctor before use if you are allergic to topical products, you are taking a diuretic, you have high blood pressure, heart disease, kidney disease, or you are pregnant.
When using this product wash hands after applying or removing patch. Avoid contact with eyes. If eye contact occurs, rinse thoroughly with water.
Stop use and consult your physician if rash, irritation, or itching develops, or condition worsens.
If pregnant or breastfeeding, ask a doctor before use while breastfeeding and during the first 6 months of pregnancy. Do not use during the last 3 months of pregnancy because it may cause problems in the unborn child or complications during delivery.
For external use only
- KEEP OUT OF REACH OF CHILDREN
- Directions
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SPL UNCLASSIFIED SECTION
INSTRUCTIONS FOR USE
- Determine area of patch application. If the pain area is smaller than the patch, patches may be cut into smaller sizes with scissors
- Safely discard the remaining unused pieces of cut patches where children and pets cannot reach
- Remove the transparent protective film (clear plastic barrier) before application of patches to the skin
- Apply immediately after removing the protective film Apply 1 patch to the affected area so that the patch covers all or most of the painful area
- Remove patch if irritation occurs
Children under 12 years of age: Consult a doctor.
- Inactive ingredients
- Other information
- Product label
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INGREDIENTS AND APPEARANCE
LIDOCAINE
lidocaine patchProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:79643-005 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 DIHYDROXYALUMINUM AMINOACETATE (UNII: DO250MG0W6) EDETATE DISODIUM (UNII: 7FLD91C86K) GLYCERIN (UNII: PDC6A3C0OX) ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS) POLYACRYLIC ACID (250000 MW) (UNII: 9G2MAD7J6W) PROPYLPARABEN (UNII: Z8IX2SC1OH) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) SODIUM POLYACRYLATE (2500000 MW) (UNII: 05I15JNI2J) TARTARIC ACID (UNII: W4888I119H) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) POLYSORBATE 80 (UNII: 6OZP39ZG8H) WATER (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:79643-005-01 10 in 1 BOX 11/29/2024 1 14 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 Drug M017 11/29/2024 Labeler - PHARMACURE LLC (055983858)