Label: CORALITE ODOR FREE PAIN RELIEF- lidocaine patch
- NDC Code(s): 65923-149-01
- Packager: United Exchange Corporation
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated December 20, 2024
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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 warning 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
- avoid the patch getting wet for better adhesion
- dispose of used patch in manner that always keeps product away from children or pets. Used patches still contain enough lidocaine to cause serious or life-threatening problems.
- 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
- expose a portion of the patch by firmly grasping an edge or corner and gently pull apart until backing separates
- position and apply exposed portion of the 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 at a time, not more than 3 to 4 times daily
- children 12 years or younger: ask a doctor
- STORAGE AND HANDLING
- INACTIVE INGREDIENT
- QUESTIONS
- DOSAGE & ADMINISTRATION
- PRINCIPAL DISPLAY PANEL
-
INGREDIENTS AND APPEARANCE
CORALITE ODOR FREE PAIN RELIEF
lidocaine patchProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:65923-149 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 GLYCERIN (UNII: PDC6A3C0OX) DIHYDROXYALUMINUM AMINOACETATE ANHYDROUS (UNII: 1K713C615K) ALCOHOL (UNII: 3K9958V90M) KAOLIN (UNII: 24H4NWX5CO) METHYLPARABEN (UNII: A2I8C7HI9T) PROPYLPARABEN (UNII: Z8IX2SC1OH) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) TARTARIC ACID (UNII: W4888I119H) SODIUM POLYACRYLATE (2500000 MW) (UNII: 05I15JNI2J) POLYSORBATE 80 (UNII: 6OZP39ZG8H) WATER (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:65923-149-01 1 in 1 POUCH 10/29/2018 1 1 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 10/29/2018 Labeler - United Exchange Corporation (840130579)