Label: LIDOCAINE 4% PAIN RELIEF GEL PATCH patch
- NDC Code(s): 55629-024-15
- Packager: ONE2ZEE LIMITED LIABILITY COMPANY
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated March 3, 2025
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- Official Label (Printer Friendly)
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Active ingredient
Lidocaine 4%
Purpose
Topical Anesthetic
Use
Temporarily relieves minor pain
Warnings
For external use only
Do not use:
- more than 1 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
- at the same time as other topical analgesics
When using this product:
• use only as directed.
• read and follow all directions and warnings on this label
• rare cases of serious burns have been reported with products of this type.
• do not apply to wounds or damaged, broken
• eyes and mucous membranes
• do not bandage tightly or apply local heat (such as
• the same time as other topical analgesics
• 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.
• a transient burning sensation may occur upon application but generally disappears in several days
• if a severe burning sensation occurs, discontinue use immediately.
• discontinue use at least 1 hour before a bath or shower.
• do not use immediately after a bath or shower.Stop use and ask doctor if: • condition worsen
• redness is present
• irritation develops
• symptoms persist for more than 7 days or clear up and occur again within a few days
• you experience signs of skin injury, such as pain, swelling, or blistering where this product is applied
if pregnant or breast feeding, ask a health professional before use.
keep out of reach of children and pets If swallowed, get medical help or contact a Poison Control Center right away.
Directions: Adult and children over 12years:
- Clean and dry affected area
- remove backing from patch by firmly grasping both ends and
- gently pulling until back separates in middle
- Carefully remove smaller portion of backing from the patch and apply exposed portion of
- patch to affected area
- use 1 patch for up to 12 hours
Inactive ingredients: Alpha Tocopherol, Aluminum Sulphate, Borax, Carbomer, Colloidal Silicon Dioxide, DMDM Hydantoin, Glycerin, Kaolin, Polyacrylic Acid, Polyvinyl Alcohol, Polyvinylpyrrolidone , Propylene Glycol, Purified Water, Sodium Carboxymethyl Cellulose, Sodium Ethylenediaminetetraacetic Acid, Sodium Polyacrylate, Sorbitol, Sorbitol Monooleate , Tartaric Acid & Titanium Dioxide, Butylated Hydroxytoluene, Polysorbate
- Package Label Box
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INGREDIENTS AND APPEARANCE
LIDOCAINE 4% PAIN RELIEF GEL PATCH
lidocaine 4% pain relief gel patch patchProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:55629-024 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987) LIDOCAINE 40 mg Inactive Ingredients Ingredient Name Strength ALUMINUM GLYCINATE (UNII: 1K713C615K) ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0) ALUMINUM BORATE (UNII: 2C1HEM26VZ) CARBOMER (UNII: 0A5MM307FC) DMDM HYDANTOIN (UNII: BYR0546TOW) ALUMINUM SULFATE (UNII: 34S289N54E) GLYCERIN (UNII: PDC6A3C0OX) KAOLIN (UNII: 24H4NWX5CO) POLYACRYLIC ACID (250000 MW) (UNII: 9G2MAD7J6W) POLYVINYL ALCOHOL (100000 MW) (UNII: 949E52Z6MY) POVIDONE K27 (UNII: H7AGY1OJO8) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) WATER (UNII: 059QF0KO0R) CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311) MAGNESIUM DISODIUM EDTA (UNII: NDT563S5VZ) SODIUM POLYACRYLATE (2500000 MW) (UNII: 05I15JNI2J) SORBITOL (UNII: 506T60A25R) SORBITOL MONOOLEATE (UNII: 658271J00C) TARTARIC ACID (UNII: W4888I119H) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K) POLYSORBATE 20 (UNII: 7T1F30V5YH) Product Characteristics Color white Score Shape RECTANGLE Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:55629-024-15 15 in 1 BOX 03/03/2025 1 1 in 1 POUCH; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M 03/03/2025 Labeler - ONE2ZEE LIMITED LIABILITY COMPANY (078656111) Registrant - ONE2ZEE LIMITED LIABILITY COMPANY (078656111) Establishment Name Address ID/FEI Business Operations DR. SABHARWAL'S WOUND CARE 862184668 manufacture(55629-024)
