UNIVERSAL PAIN RELIEF- lidocaine patch

Universal PAIN RELIEF by

Drug Labeling and Warnings

Universal PAIN RELIEF by is a Otc medication manufactured, distributed, or labeled by Universal Distribution Center LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient

Lidocaine 4%

Purpose

Topical anesthetic

Uses:

For temporary relief of pain

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 days

If pregnant or breast-feeding, ask a health professional before use

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

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

• Avoid storing product in direct sunlight
• Protect product from excessive moisture

Inactive ingredients

Glycerin, Sodium Polyacrylate, Dihydroxyaluminum Aminoacetate, Disodium Ethylenediaminetetraacetic Acid, Kaolin, Titanium Dioxide, Polysorbate 80, Propylene Glycol, Tartaric Acid, Polyacrylic Acid, Polyvinylpyrrolidone K90, Methylparaben, Propylparaben, Water

SPL UNCLASSIFIED SECTION

HOT & COLD RELIEF

FAST ACTING
PAIN RELIEF

DESENSITIZE 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 skin

USE 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.com

Made in P.R.C

Packaging

INGREDIENTS AND APPEARANCE

UNIVERSAL PAIN RELIEF 
lidocaine patch

Product 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 not final	part348	06/30/2023

Labeler - Universal Distribution Center LLC (019180459)