Label: UNIVERSAL PAIN RELIEF- lidocaine patch
- NDC Code(s): 52000-407-01
- Packager: Universal Distribution Center LLC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated October 14, 2024
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- Official Label (Printer Friendly)
- Active ingredient
- Purpose
- Uses:
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Warnings
For external use only
Do not use: • More than 1 patch at a time • On wounds or damaged skin • With a heating pad • If you are allergic to any ingredients of this product
When using this product: • Use only as directed • Avoid contact with the eyes, mucous membranes or rashes • Do not bandage tightly
Stop use and ask a doctor if: • localized skin reactions occur, such as rash, itching, redness, irritation, pain, swelling and blistering
• Conditions worsen
• Symptoms persists for more than 7 days
• Symptoms clear up and occur again within a few daysIf pregnant or breast-feeding, ask a health professional before use
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Directions
Adult and Children 12 years of age and over:
- Clean and dry affected area
- Remove film from patch and apply to the skin (see illustration)
- Apply 1 patch at a time to affected area, not more than 3 to 4 times daily
- Remove patch from the skin after at most 8-hour application
Children under 12 years of age: Consult a doctor
- Other information
- Inactive ingredients
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SPL UNCLASSIFIED SECTION
HOT & COLD RELIEF
FAST ACTING
PAIN RELIEFDESENSITIZE AGGRAVATED NERVES
- Back
- Neck
- Shoulders
- Knees & Elbows
APPLY FOR 8 HOURS
CONTAINS FIVE 5.5"X3.94" INDIVIDUALLY PACKED PATCHES
HOW TO APPLY
1. Remove patch from outer package
2. Partially peel back protective film
3. Place on affected area
4. Remove remaining film while pressing patch to skinUSE COLD
For temporary relief of pain associated with:
- Swelling
- Sprains & Strains
- Bumps & Bruises
- Sports injury
- Toothache
- Fever
USE HOT
For temporary relief of pain associated with:
- Muscle aches
- Mild Arthritis
- Menstrual cramps
- Joint stiffness
- Sports injury
Mfd and Distributed By:
Universal Distribution Center
96 Distribution Boulevard, Edison, NJ 08817
www.universaldc.comMade in P.R.C
- Packaging
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INGREDIENTS AND APPEARANCE
UNIVERSAL PAIN RELIEF
lidocaine patchProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:52000-407 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987) LIDOCAINE 0.04 g in 1 g Inactive Ingredients Ingredient Name Strength GLYCERIN (UNII: PDC6A3C0OX) SODIUM POLYACRYLATE (2500000 MW) (UNII: 05I15JNI2J) DIHYDROXYALUMINUM AMINOACETATE ANHYDROUS (UNII: 1K713C615K) EDETATE DISODIUM (UNII: 7FLD91C86K) KAOLIN (UNII: 24H4NWX5CO) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) POLYSORBATE 80 (UNII: 6OZP39ZG8H) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) TARTARIC ACID (UNII: W4888I119H) POLYACRYLIC ACID (250000 MW) (UNII: 9G2MAD7J6W) POVIDONE K90 (UNII: RDH86HJV5Z) METHYLPARABEN (UNII: A2I8C7HI9T) PROPYLPARABEN (UNII: Z8IX2SC1OH) WATER (UNII: 059QF0KO0R) Product Characteristics Color white Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:52000-407-01 5 in 1 BOX 06/30/2023 1 1 in 1 BAG 1 12 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 06/30/2023 Labeler - Universal Distribution Center LLC (019180459)
