Label: LIDOCAINE 4% MAXIMUM OTC STRENGTH- lidocaine patch
- NDC Code(s): 55154-7813-5
- Packager: Cardinal Health 107, LLC
- This is a repackaged label.
- Source NDC Code(s): 0536-1202
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated June 20, 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 and Usage
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Warnings
For external use only.
Do not use
■ More than one 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
■ If you are allergic to any active or inactive ingredients
■ If pouch is damaged or opened.
When using this product
■ Use only as directed
■ Read and follow all directions and warnings on this carton
■ Do not allow contact with the eyes
■ Do not use at the same time as other topical analgesics
■ Do not bandage tightly or apply local heat (such as heating pads) to the area of use
■ Do not microwave
■ Dispose of used patch in manner that always 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.
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Directions
Directions Adults and children 12 years of age and over: Clean and dry affected area, free of lotions, ointments and creams. Carefully remove backing from patch starting at a corner. Apply sticky side of patch to affected area. Do not more than use one patch in a 12 hour period. Maximum 2 patches per day. Discard patch after single use. Children under 12 years of age: consult a physician.
- Other information
- Inactive Ingredients
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Questions or comments
Call 1-866-326-1313
This product is not manufactured or distributed by Chattem Inc., owner of the registered trademark Aspercreme®.
Distributed by:
RUGBY® LABORATORIES
Indianapolis, IN 46268
Distributed By:
Cardinal Health
Dublin, OH 43017
Made in China
Questions or comments?
Call 1-800-616-2471
www.majorpharmaceuticals.com
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INGREDIENTS AND APPEARANCE
LIDOCAINE 4% MAXIMUM OTC STRENGTH
lidocaine patchProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:55154-7813(NDC:0536-1202) 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 ALUMINUM (UNII: CPD4NFA903) GLYCERIN (UNII: PDC6A3C0OX) KAOLIN (UNII: 24H4NWX5CO) METHYLPARABEN (UNII: A2I8C7HI9T) POLYACRYLIC ACID (300000 MW) (UNII: A8371R0U5J) POLYSORBATE 80 (UNII: 6OZP39ZG8H) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) PROPYLPARABEN (UNII: Z8IX2SC1OH) POVIDONE, UNSPECIFIED (UNII: FZ989GH94E) SODIUM POLYACRYLATE (2500000 MW) (UNII: 05I15JNI2J) TARTARIC ACID (UNII: W4888I119H) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) WATER (UNII: 059QF0KO0R) Product Characteristics Color Score Shape RECTANGLE Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:55154-7813-5 5 in 1 BAG 06/20/2024 1 9 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 04/01/2019 Labeler - Cardinal Health 107, LLC (118546603)